Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Sponsor: Daiichi Sankyo

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CLINICAL STUDY PROTOCOL 
PHASE 3 RANDOMIZED STUDY OF DS-1062A VERSUS 
DOCETAXEL IN PREVIOUSLY TREATED ADVANCED 
OR METASTATIC NON-SMALL CELL LUNG CANCER 
WITH OR WITHOUT ACTIONABLE GENOMIC 
ALTERATIONS (TROPION-LUNG01) 
(DS-1062a Versus Docetaxel in Previously Treated 
Advanced or Metastatic Non-Small Cell Lung Cancer) 
 
PROTOCOL NUMBER: DS1062-A-U301F 
(TROPION-LUNG01) 
 
IND 136626 
EudraCT NUMBER 2020-004643-80  
NCT Number: NCT04656652 
 
VERSION 5.0, Date 09 OCT 2023 
 
DAIICHI SANKYO, INC. 
211 MOUNT AIRY ROAD 
BASKING RIDGE, NEW JERSEY 07920 
 
CONFIDENTIALITY STATEMENT 
Information contained in this document is proprietary to Daiichi Sankyo, Inc.  The information is 
provided to you in confidence which is requested under an agreed upon and signed 
Confidentiality and Disclosure Agreement.  Do not give this document or any copy of it or reveal 
any proprietary information contained in it to any third party (other than those in your 
organization who are assisting you in this work and are bound by the Confidentiality and 
Disclosure Agreement) without the prior written permission of an authorized representative of 
Daiichi Sankyo, Inc. 

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INVESTIGATOR AGREEMENT 
PHASE 3 RANDOMIZED STUDY OF DS-1062A VERSUS DOCETAXEL IN 
PREVIOUSLY TREATED ADVANCED OR METASTATIC NON-SMALL 
CELL LUNG CANCER WITH OR WITHOUT ACTIONABLE GENOMIC 
ALTERATIONS (TROPION-LUNG01) 
 
 
 
 
Investigator’s Signature: 
I have fully discussed the objectives of this study and the contents of this protocol with the Sponsor’s 
representative. 
I understand that information contained in or pertaining to this protocol is confidential and should not be 
disclosed, other than to those directly involved in the execution or the ethical review of the study, without 
written authorization from the Sponsor.  It is, however, permissible to provide information to a subject in 
order to obtain consent. 
I agree to conduct this study according to this protocol and to comply with its requirements, subject to 
ethical and safety considerations and guidelines, and to conduct the study in accordance with International 
Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) 
Guideline for Good Clinical Practice (ICH E6[R2]), which has its foundations in the Declaration of 
Helsinki, and applicable regional regulatory requirements. 
I agree to make available to Sponsor personnel, their representatives and relevant regulatory authorities, my 
subjects’ study records in order to verify the data that I have entered into the case report forms.  I am aware 
of my responsibilities as a Principal Investigator as provided by the Sponsor. 
I understand that the Sponsor may decide to suspend or prematurely terminate the study at any time for 
whatever reason; such a decision will be communicated to me in writing. 
Conversely, should I decide to withdraw from execution of the study, I will communicate my intention 
immediately in writing to the Sponsor. 
 
 
Print Name 
Signature 
 
 
Title 
Date (DD MMM YYYY) 
 

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DOCUMENT HISTORY 
Version Number 
Version Date 
5.0 
09 Oct 2023 
4.0 
20 Jan 2022 
3.0 
01 Oct 2021 
2.0 
03 Mar 2021 
1.0 
05 Oct 2020 
 

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SUMMARY OF CHANGES 
Please refer to the comparison document for protocol Version 4.0 (dated 20 Jan 2022) versus 
protocol Version 5.0 (09 Oct 2023) for the actual changes in text.  The summary of changes 
below is a top-line summary of major changes in the current DS1062-A-U301 clinical study 
protocol (Version 5.0) by section. 
Amendment Rationale: 
The main purpose of this amendment is to update the safety information for the DS-1062a 
investigational product. 
CONVENTIONS USED IN THIS SUMMARY OF CHANGES 
All locations (section numbers and/or paragraph/bullet numbers) refer to the current protocol 
version, which incorporates the items specified in this Summary of Changes document. 
Minor edits, such as update to language that does not alter original meaning, update to version 
numbering, updates to references, formatting, change in font color, corrections to 
typographical errors, use of abbreviations, moving verbiage within a section or table, change in 
style, or change in case, are not noted in the table below. 

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Section # and Title 
Description of Change 
Brief Rationale 
1.3 Schedule of Events 
Tables 1.1, 1.2, and 6.4 
2.3.1 Benefit-Risk in Regard to 
COVID-19 
6.5 Guidelines for Dose 
Modification 
8.4.1.2 Adverse Events of 
Special Interest 
(Dose) “interrupted” was replaced with “delayed”, with the new term “infusion 
interruption” meaning stopping a dose during an infusion. 
To clarify whether a subject had 
an interruption of an infused 
dose versus having an upcoming 
dose delayed, eg, due to an 
adverse event.  
1.3 Schedule of Events 
6.5.1 DS-1062a 
8.4.1.2 Adverse Events of 
Special Interest 
For suspected ILD/pneumonitis events, the following changes in evaluations were 
made: 
 
  
To reflect the most recent safety 
information. 
1.3 Schedule of Events 
6.1 Study Drug Description 
6.2.1 DS-1062a 
6.5.1 DS-1062a 
Added “If a subject doesn’t experience any IRR during or after the first 2 cycles, the 
post-infusion observation period can be shortened to at least 30 minutes for subsequent 
cycles. Subjects with identified IRR related to the study drug should be observed post-
infusion for at least 1 hour for the 2 cycles after the IRR event and for at least 30 
minutes at each subsequent cycle.” 
To shorten the 1-hour 
observation period after infusion, 
if appropriate 
6.5 Guidelines for Dose 
Modification 
6.5.1 DS-1062a 
10.7 Appendix 8: Instructions 
Related to Coronavirus 
Disease 2019 (COVID-19) 
Increased allowed dose delay time from 49 to 84 days from last dose. 
The following text was edited to reflect this: 
 
To allow those subjects receiving 
clinical benefit but requiring 
more recovery time to continue 
to receive treatment without 
being discontinued. 

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Section # and Title 
Description of Change 
Brief Rationale 
1.3 Schedule of Events 
Tables 1.1, 1.2 
Section 6.5.1 
Table 6.4 
The following statement was added: The importance of multiple daily mouth rinses 
during treatment (eg, prior to dosing) and up to the first follow-up visit should be 
emphasized. 
To aid in preventing oral 
mucositis/stomatitis AEs, 
respectively. 
1.3 Schedule of Events 
Tables 1.1, 1.2 
The following statement was added: It should be strongly recommended that subjects 
avoid the use of contact lenses starting on the day of the first DS-1062a dose and to use 
artificial tears (preferably preservative-free) 4 times per day as preventative measure 
and up to 8 times per day as clinically needed. 
To prevent ocular surface 
toxicity AEs. 
2.2 Study Rationale 
2.3 Benefit and Risk 
Assessment 
4.3 Justification for Dose 
6.5 DS-1062a 
Table 6.4 
8.4.1.1 Serious Adverse Event 
Reporting 
8.4.1.2. Adverse Events of 
Special Interest 
In many cases, the term “IRR including anaphylaxis” was changed to “IRR.” 
Anaphylaxis is no longer 
considered an appreciable IRR. 
8.4.1.2. Adverse Events of 
Special Interest 
The terms stomatitis and mucosal inflammation were clarified to mean: 
Oral mucositis/stomatitis TEAEs and mucosal inflammation TEAEs occurring in the 
GI tract. 
These terms are similar but need 
clarification for classification as 
AESIs. 
4.1.1 Design Overview 
8.3 Efficacy Assessments 
Added “To ensure accurate survival data are available at the time of any database lock, 
updated survival status may be requested during the course of the study by the 
Sponsor. For example, updated survival status may be requested prior to, but not 
limited to, an IDMC review. Upon Sponsor notification, all subjects who do not/will 
not have a scheduled study visit or study contact during the sponsor-defined period 
will be contacted for their survival status (excluding subjects who have a previously 
recorded death event in the collection tool).” 
To ensure survival data are 
accurately documented. 
6.2 Preparation, Handling, 
Storage, and Accountability 
for Study Drug 
6.2.2 Docetaxel 
The storage of docetaxel was clarified, with the following edits: 
 
For enhanced clarity 

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Section # and Title 
Description of Change 
Brief Rationale 
6.5.1 DS-1062a 
Table 6.4 
Dose modifications for DS-1062a were updated by grade for IRR, hematologic, 
pulmonary, ocular surface, GI, and oral toxicities. 
To reflect the most recent safety 
information. 
6.6 Prior and Concomitant 
Medications 
Added, “All concomitant medications administered during the study should be 
recorded in the eCRF until the end of the Safety Follow-Up Period. Concomitant 
medications administered as treatment for drug-related AESIs should be recorded until 
either event resolution, end of study, study termination, withdrawal of consent, or 
subject death.” 
To reinforce the importance of 
following all AESIs. 
6.6 Prior and Concomitant 
Medications 
Updated permitted therapies to remove restriction on using bisphosphonates and 
RANKL targeting agents. Added language to highly recommend the use of anti-emetic 
agents prior to DS-1062a treatment. 
To reflect updated safety 
information. 
6.6 Prior and Concomitant 
Medications 
The following changes were made for when the Sponsor needs to be notified for 
concomitant use of corticosteroids: 
 
> 10 mg/day of prednisone or an 
equivalent is an important cutoff 
the Sponsor is monitoring 
7.2 Subject 
Withdrawal/Discontinuation 
from the Study 
Added, “If the subject refuses routine follow-up, the Investigator should discuss with 
the subject if sparse survival follow-up by telephone or verification of medical records 
is permitted prior to database locks.” 
To clarify the option of sparse 
contacts for survival follow-up 
only. 
8.4.1.1 Serious Adverse Event 
Reporting 
Section title changed to “8.4.1.1. Adverse Event Reporting”. 
Added Grade ≥ 2 keratitis events (including keratitis, punctate keratitis, and ulcerative 
keratitis) to be reported in 24 hours upon occurrence. 
To reflect updated safety 
information. 
8.4.1.2. Adverse Events of 
Special Interest 
Added, “All AESIs, regardless of severity or seriousness, must be followed until either 
event resolution, end of study including any post-treatment follow-up (if applicable), 
study termination, withdrawal of consent, or subject death.” 
To ensure all AESIs are followed 
to resolution. 
8.4.1.2. Adverse Events of 
Special Interest 
Added “An autopsy in cases of Grade 5 ILD/pneumonitis is encouraged.” 
An autopsy may provide 
valuable safety information. 
2.2 Study Rationale 
2.3 Benefit and Risk 
Assessment 
4.3 Justification for Dose 
8.4.1.2. Adverse Events of 
Special Interest 
IRR was downgraded from an important identified risk to an identified risk 
Current safety data suggests the 
incidence and severity of IRR 
events meet the standards for an 
identified risk. 
No additional pharmacovigilance 
(PV) or risk minimization (RM) 
activities are planned and IRR is 

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Section # and Title 
Description of Change 
Brief Rationale 
integrated and managed through 
standard clinical practice. 
Table 6.4  
Toxicity Management Guidelines: 
The management guidelines for IRR TEAE grades were updated focusing on reducing 
infusion rates by 50%, yielding a doubling in total infusion times.   
This strategy allows full doses 
while minimizing the severities 
and durations of IRR TEAEs. 
For Grade 4 decreased ANC and WBC, delay dose until ≤ Grade 2, then maintain dose 
if this occurs ≤ 14 days or decrease by one dose level if this occurs > 14 days 
These cutoffs have been 
determined from current safety 
data. 
8.4.2 Pregnancy 
Added, “Women must not get pregnant, breastfeed, or donate/retrieve ova during the 
study and for at least 7 months after stopping DS-1062a or for at least 6 months after 
stopping docetaxel.” 
To match text present in the 
informed consent form. 

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TABLE OF CONTENTS 
INVESTIGATOR AGREEMENT...................................................................................................2 
DOCUMENT HISTORY.................................................................................................................3 
SUMMARY OF CHANGES ...........................................................................................................4 
Amendment Rationale: ....................................................................................................................4 
1. 
PROTOCOL SUMMARY ..............................................................................................15 
1.1. 
Protocol Synopsis ............................................................................................................15 
1.2. 
Study Schema ..................................................................................................................29 
1.3. 
Schedules of Events .........................................................................................................30 
2. 
INTRODUCTION ...........................................................................................................53 
2.1. 
Background ......................................................................................................................53 
2.1.1. 
Non-Small Cell Lung Cancer ..........................................................................................53 
2.1.2. 
DS-1062a .........................................................................................................................54 
2.2. 
Study Rationale ...............................................................................................................54 
2.3. 
Benefit and Risk Assessment ..........................................................................................57 
2.3.1. 
Benefit-Risk in Regard to COVID-19 .............................................................................58 
3. 
OBJECTIVES, OUTCOME MEASURES, AND ENDPOINTS ....................................59 
3.1. 
Rationale for Selection of Primary and Secondary Endpoints ........................................63 
4. 
STUDY DESIGN ............................................................................................................64 
4.1. 
Overall Design .................................................................................................................64 
4.1.1. 
Design Overview .............................................................................................................64 
4.1.2. 
Study Completion ............................................................................................................67 
4.1.3. 
Dose Regimen .................................................................................................................67 
4.1.3.1. DS-1062a .........................................................................................................................67 
4.1.3.2. Docetaxel .........................................................................................................................68 
4.1.4. 
Duration ...........................................................................................................................68 
4.2. 
Rationale for Study Design .............................................................................................69 
4.3. 
Justification for Dose .......................................................................................................71 
5. 
STUDY POPULATION ..................................................................................................73 
5.1. 
Inclusion Criteria .............................................................................................................73 
5.2. 
Exclusion Criteria ............................................................................................................77 
5.3. 
Screening Failures, Rescreening, and Subject Replacement ...........................................80 

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6. 
STUDY TREATMENT ...................................................................................................81 
6.1. 
Study Drug Description ...................................................................................................81 
6.1.1. 
DS-1062a .........................................................................................................................81 
6.1.2. 
Docetaxel .........................................................................................................................82 
6.2. 
Preparation, Handling, Storage, and Accountability for Study Drug ..............................82 
6.2.1. 
DS-1062a .........................................................................................................................82 
6.2.2. 
Docetaxel .........................................................................................................................84 
6.3. 
Measure to Minimize Bias: Randomization and Blinding ..............................................85 
6.4. 
Treatment Compliance ....................................................................................................85 
6.5. 
Guidelines for Dose Modification ...................................................................................85 
6.5.1. 
DS-1062a .........................................................................................................................86 
6.5.2. 
Docetaxel .........................................................................................................................97 
6.6. 
Prior and Concomitant Medications ................................................................................99 
7. 
STUDY DRUG DISCONTINUATION AND DISCONTINUATION FROM 
THE STUDY .................................................................................................................102 
7.1. 
Discontinuation of Study Treatment .............................................................................102 
7.2. 
Subject Withdrawal/Discontinuation from the Study ....................................................104 
7.3. 
Lost to Follow-Up .........................................................................................................105 
8. 
STUDY PROCEDURES ...............................................................................................106 
8.1. 
Eligibility Assessment ...................................................................................................106 
8.2. 
Randomization ...............................................................................................................108 
8.3. 
Efficacy Assessments ....................................................................................................109 
8.4. 
Safety Assessments .......................................................................................................111 
8.4.1. 
Adverse Event ...............................................................................................................111 
8.4.1.1. Adverse Event Reporting ..............................................................................................113 
8.4.1.2. Adverse Events of Special Interest ................................................................................115 
8.4.1.3. Hepatic Events ...............................................................................................................118 
8.4.2. 
Pregnancy ......................................................................................................................118 
8.4.3. 
Clinical Laboratory Evaluations ....................................................................................119 
8.4.4. 
Other Safety ...................................................................................................................119 
8.5. 
Pharmacokinetic Assessments .......................................................................................121 
8.6. 
Biomarker and Pharmacodynamic Assessments ...........................................................122 
8.6.1. 
Exploratory Biomarker Assessments in Blood Samples ...............................................123 

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8.6.2. 
Exploratory Biomarker Assessments in Tumor Tissues ...............................................123 
8.6.3. 
Additional Exploratory Biomarker Assessments ..........................................................124 
8.6.4. 
TROP2 Immunohistochemistry Analysis ......................................................................124 
8.6.5. 
Pharmacogenomic (Inherited Genetic) Analysis ...........................................................124 
8.6.5.1. Banking of Specimens for Inherited Genetic Analysis .................................................125 
8.6.6. 
Immunogenicity .............................................................................................................125 
9. 
STATISTICAL CONSIDERATIONS ..........................................................................126 
9.1. 
General Statistical Considerations .................................................................................126 
9.2. 
Statistical Hypothesis ....................................................................................................126 
9.3. 
Sample Size Determination ...........................................................................................127 
9.4. 
Population for Analysis Sets .........................................................................................127 
9.5. 
Statistical Analysis ........................................................................................................128 
9.5.1. 
Efficacy Analyses ..........................................................................................................128 
9.5.1.1. Primary Efficacy Analyses ............................................................................................128 
9.5.1.2. Secondary Efficacy Analyses ........................................................................................129 
9.5.1.3. Exploratory Efficacy Analyses ......................................................................................130 
9.5.1.4. Multiplicity Adjustment ................................................................................................130 
9.5.2. 
Safety Analyses .............................................................................................................131 
9.5.3. 
Other Analyses ..............................................................................................................132 
9.6. 
Interim Analyses ............................................................................................................133 
10. 
APPENDICES – SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ....................................................................................................134 
10.1. 
Appendix 1 Regulatory and Ethical Considerations .....................................................134 
10.1.1. Regulatory Compliance .................................................................................................134 
10.1.2. Informed Consent ..........................................................................................................135 
10.1.3. Subject Confidentiality ..................................................................................................136 
10.1.4. Data Integrity and Quality Assurance ...........................................................................136 
10.1.5. Committees ....................................................................................................................137 
10.1.6. Study Documentation and Storage ................................................................................138 
10.1.7. Finances .........................................................................................................................139 
10.1.8. Publication, Public Disclosure Policy, and Data Sharing ..............................................140 
10.1.9. Protocol Deviations .......................................................................................................140 
10.1.10. Study and Site Closure ..................................................................................................140 

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10.1.11. Product Complaints .......................................................................................................141 
10.2. 
Appendix 2: Laboratory Tests .......................................................................................141 
10.3. 
Appendix 3: Reference Standards .................................................................................142 
10.3.1. Cockcroft-Gault Equation .............................................................................................142 
10.3.2. New York Heart Association .........................................................................................143 
10.3.3. Eastern Cooperative Oncology Group Performance Status ..........................................143 
10.3.4. Highly Effective Contraception .....................................................................................144 
10.4. 
Appendix 4: Response Evaluation Criteria in Solid Tumors (Version 1.1.) .................144 
10.5. 
Appendix 6: General Information – Adverse Events ....................................................152 
10.5.1. Definition of Adverse Event ..........................................................................................152 
10.5.2. Serious Adverse Event ..................................................................................................153 
10.5.3. Grade Assessment .........................................................................................................154 
10.5.4. Causality Assessment ....................................................................................................155 
10.5.5. Action Taken Regarding Study Drug ............................................................................155 
10.5.6. Other Action Taken for Event .......................................................................................156 
10.5.7. Adverse Event Outcome ................................................................................................156 
10.6. 
Appendix 7: Key Data Analysis Requirements .............................................................156 
10.7. 
Appendix 8: Instructions Related to Coronavirus Disease 2019 (COVID-19) .............157 
10.8. 
Appendix 9: Patient-reported Outcomes .......................................................................159 
10.8.1. EORTC-QLQ-C30 ........................................................................................................159 
10.8.2. EORTC-QLQ-LC13 ......................................................................................................159 
10.8.3. EQ-5D-5L ......................................................................................................................159 
10.8.4. PRO-CTCAE 1-3; 24; 28-29; 51; 74 .............................................................................159 
10.9. 
Appendix 10: Country-specific Protocol Text ..............................................................159 
10.9.1. Czech Republic ..............................................................................................................159 
10.9.2. Argentina .......................................................................................................................160 
11. 
REFERENCES ..............................................................................................................161 
12. 
LIST OF ABBREVIATIONS .......................................................................................164 
 

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LIST OF TABLES 
Table 1.1: Schedule of Events for Screening and Cycles 1 through 3 of the Treatment 
Period ..........................................................................................................................30 
Table 1.2: Schedule of Events for Cycle 4 and Subsequent Cycles of the Treatment 
Period, End of Treatment, and Follow-up Period .......................................................42 
Table 3.1: Description of Objectives, Outcome Measures, and Endpoints .................................59 
Table 6.1: DS-1062a Dosing Information ...................................................................................81 
Table 6.2: Docetaxel Dosing Information ...................................................................................82 
Table 6.3: Dose Reduction Levels for DS-1062a ........................................................................86 
Table 6.4: Dose Modifications for Non-hematologic and Hematologic Toxicity Related 
to DS-1062a ................................................................................................................88 
Table 6.5: Dose Reduction Levels for Docetaxel ........................................................................98 
Table 8.1: Pharmacokinetic Sampling Collection .....................................................................122 
Table 10.1: Clinical Laboratory Tests .........................................................................................141 
Table 10.2: New York Heart Association Classifications ...........................................................143 
Table 10.3: Eastern Cooperative Oncology Group Performance Status ......................................143 
Table 10.4: Time Point Response: Subjects with Target (±Non-target) Disease ........................150 
Table 10.5: Overall Response: Subjects with Non-target Disease Only .....................................150 
Table 10.6: Overall Best Overall Response When Confirmation of CR and PR Required .........151 
Table 10.7: COVID-19 Dose Modification Criteria ....................................................................157 
 

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LIST OF FIGURES 
Figure 1.1: Study Level Flow Diagram .........................................................................................29 
 

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Title: DCR 
Description:  
DCR as assessed by BICR and 
Investigator per RECIST v1.1. 
Time frame:  
At the time of the primary 
analyses of PFS and OS.  
DCR is defined as the 
proportion of subjects 
who achieved a BOR 
of CR, PR, or SD.  
Efficacy 
Title: TTR 
Description:  
TTR as assessed by BICR and 
Investigator per RECIST v1.1. 
Time frame:  
At the time of the primary 
analyses of PFS and OS.  
TTR is defined as the 
time from 
randomization to the 
date of the first 
documentation of 
objective response 
(CR or PR) in 
responding subjects. 
Efficacy 
Title: TTD 
Description:  
TTD in any of the 3 
symptoms, chest pain, cough, 
or dyspnea.  
Time frame:  
At the time of the primary 
analyses of PFS and OS. 
 
EORTC-QLQ-LC13 
(except questions 36 
and 37) 
The TTD is defined as 
the time from 
randomization to first 
onset of a ≥10-point 
increase in cough, 
chest pain, or dyspnea, 
confirmed by a second 
≥10-point increase 
from randomization in 
the same symptom at 
the next scheduled 
assessment, or 
confirmed by death 
within 21 days of the 
first ≥10-point 
increase from 
randomization. 
Efficacy 
To further evaluate 
the safety of 
DS-1062a 
compared with 
docetaxel 
Title: TEAEs and other safety 
parameters during the study 
Description:  
Descriptive statistics of safety 
endpoints. 
Time frame:  
Continuous monitoring and 
reported at the time of the 
primary analyses of PFS and 
OS. 
 
TEAEs, SAEs, AESIs, 
ECOG PS, vital sign 
measurements, 
standard clinical 
laboratory parameters 
(hematology, serum 
chemistry, and 
urinalysis), ECG 
parameters, 
ECHO/MUGA scan 
findings, and 
ophthalmologic 
findings.  AEs will be 
coded by the most 
Safety 

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used to treat 
NSCLC. 
expression, protein 
expression, and 
pharmacogenomics 
may be measured in 
tumor and blood 
samples. 
To explore how 
changes in 
biomarkers may 
relate to exposure 
and clinical 
outcomes. 
Not applicable 
Biomarkers will be 
assessed in cell-free 
DNA pre- and 
post-treatment. 
Biomarkers 
To evaluate 
exposure-response 
relationships for 
efficacy and safety 
endpoints. 
Not applicable 
Characterize 
population PK and its 
relationship with 
efficacy and safety 
endpoints, and 
evaluate the effects of 
covariates (eg, body 
weight) on PK, 
efficacy, and safety. 
PK 
To evaluate PRO 
endpoints for DS-
1062a compared 
with that of 
docetaxel. 
Title: Patient-reported 
Outcomes 
• 
Change from baseline in 
QLQ-C30 functioning 
scales. 
• 
Change from baseline in 
global health (QLQ-C30 
question No. 29). 
• 
Change from baseline in 
quality of life (QLQ-C30 
question No. 30). 
• 
Change from baseline in 
overall health status 
(EQ-5D Visual Analog 
Scale). 
• 
Summary statistics (ie, 
frequency distributions) 
for each PRO-CTCAE. 
Time frame: At the time of 
the primary analyses of PFS 
and OS. 
EORTC-QLQ-C30 
EORTC-QLQ-LC13 
(except questions 36 
and 37) 
EQ-5D-5L 
PRO-CTCAE 1-3; 
24;28-29;51;74 
Patient-reported outcomes 
ADA = antidrug antibody; AE = adverse event; AESI = adverse event of special interest; AUCinf = area under 
the plasma concentration-time curve up to infinity; AUClast = area under the plasma concentration-time curve up 
to the last quantifiable time; AUCtau = area under the plasma concentration-time curve during dosing interval; 
BICR = blinded independent central review; BOR = best overall response; CBR = clinical benefit rate; CL = total 
body clearance; Cmax = maximum plasma concentration; CR = complete response; DCR = disease control rate; 
DoR = duration of response; ECG = electrocardiogram; ECHO = echocardiogram; ECOG PS = Eastern 
Cooperative Oncology Group performance status; EORTC-QLQ-C30 = European Organisation for Research and 
Treatment of Cancer Quality of Life Questionnaire Core 30; EORTC-QLQ-LC13 = European Organisation for 
Research and Treatment of Cancer Quality of Life Lung Cancer 13; EQ-5D-5L = EuroQol Questionnaire- 5 

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Key Inclusion Criteria:  
Subjects eligible for inclusion in the study must meet all inclusion criteria for this study within 28 days before 
randomization.  Below is a list limited to the key inclusion criteria: 
• 
Subject has pathologically documented Stage IIIB, IIIC or Stage IV NSCLC with or without AGA (note: 
NSCLC subjects with AGA are eligible under Protocol version 4.0) at the time of randomization (based on 
the American Joint Committee on Cancer, Eighth Edition) and meets the following criteria for NSCLC: 
Subjects without AGA: 
1. Subjects must have documented negative test results for EGFR and ALK genomic alterations.  If 
test results for EGFR and ALK are not available, subjects are required to undergo testing performed 
locally for these genomic alterations.  
2. Subjects have no known genomic alterations in ROS1, NTRK, BRAF, MET exon 14 skipping, or 
RET. 
▪ 
In Argentina only, please see Section 10.9.2 for modified text applicable to Argentina. 
3. Subjects with known KRAS mutations (testing during screening is not mandatory), in the absence 
of any driver genomic alterations, are eligible and must meet the prior therapy requirements for 
subjects without actionable genomic alterations described below.  These subjects must be stratified 
as NSCLC without AGA at the time of randomization. 
Subjects with AGA: 
1. Subjects must have one or more documented actionable genomic alteration: EGFR, ALK, ROS1, 
NTRK, BRAF, MET exon 14 skipping, or RET.  
• 
Subjects with documentation of radiographic disease progression while on or after receiving the most recent 
treatment regimen for advanced or metastatic NSCLC.   
• 
Subjects must meet the following prior therapy requirements: 
Subjects without AGA must meet ONE of the following prior therapy requirements for advanced or 
metastatic NSCLC:  
a. Received platinum-based chemotherapy in combination with α-PD-1/α-PD-L1 monoclonal 
antibody as the only prior line of therapy. 
▪ 
Includes subjects who received prior platinum-based chemotherapy with or without 
radiotherapy with maintenance α-PD-1/α-PD-L1 monoclonal antibody for Stage III disease 
and relapsed/progressed within 6 months from the last dose of platinum-based 
chemotherapy. 
▪ 
Includes subjects who received prior platinum-based chemotherapy with or without 
radiotherapy (with or without maintenance α-PD-1/α-PD-L1 monoclonal antibody) for 
Stage III disease and subsequently received α-PD-1/α-PD-L1 monoclonal antibody therapy 
(with or without platinum-based chemotherapy) for recurrent disease. 
OR 
b. Received platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody (in either 
order) sequentially as the only 2 prior lines of therapy. 
NOTE: 
i. Subjects who received α-PD-1/α-PD-L1 monoclonal antibody as frontline therapy may have 
received the combination of platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal 
antibody in the second line. 
ii. Subjects with known KRAS mutations, in the absence of other AGA, who received KRAS-
approved target therapy (eg, sotorasib) as a separate line of therapy in addition to the prior therapy 
requirements described above are not eligible. 
Subjects with AGA must meet the following for advanced or metastatic NSCLC: 

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a. 
Subjects who have been treated with 1 or 2 prior lines of applicable targeted therapy that is 
locally approved for the subject’s genomic alteration at the time of screening; OR one or more of 
the agents specified in the table below: 
▪ 
Subjects who have tumors with EGFR L858R or exon 19 deletion mutations must 
have received prior Osimertinib. 
▪ 
Those who received a targeted agent as adjuvant therapy for early-stage disease must 
have relapsed or progressed while on the treatment or within 6 months of the last dose 
OR received at least one additional course of targeted therapy for the same genomic 
alteration (which may or may not be same agent used in the adjuvant setting) for 
relapsed/progressive disease. 
▪ 
Subjects who have been treated with a prior TKI must receive additional approved 
targeted therapy, if locally available and clinically appropriate, for the applicable 
genomic alteration, or the subject will not be allowed in the study. 
 
Genomic Alterations 
Applicable Targeted Agents 
EGFR 
erlotinib, gefitinib, afatinib, dacomitinib, and osimertinib 
EGFR exon 20 insertion 
amivantamab, mobocertinib 
EGFR T790M 
osimertinib 
ALK fusion 
crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib 
ROS-1 fusion 
entrectinib, lorlatinib, ceritinib, and crizotinib 
NTRK fusion 
entrectinib and larotrectinib 
BRAF V600E 
dabrafenib, alone or in combination with trametinib 
MET exon 14 skipping 
capmatinib and tepotinib 
RET rearrangement 
selpercatinib and pralsetinib  
ALK = anaplastic lymphoma kinase; BRAF = proto-oncogene B-raf; EGFR = epidermal growth factor 
receptor; MET = mesenchymal-epithelial transition; NTRK = neurotrophic tyrosine receptor kinase; 
RET = rearranged during transfection; ROS-1 = ROS proto-oncogene 1; TKI = tyrosine kinase inhibitor 
 
b. Subjects who have received platinum-based chemotherapy as the only prior line of cytotoxic 
therapy: 
▪ 
One platinum-containing regimen for advanced disease  
▪ 
Those who received a platinum-containing regimen as adjuvant therapy for early-stage 
disease must have relapsed or progressed while on the treatment or within 6 months of 
the last dose OR received at least one additional course of platinum-containing therapy 
(which may or may not be same as in the adjuvant setting) for relapsed/progressive 
disease. 
c. 
May have received up to one α-PD-1/α-PD-L1 monoclonal antibody alone or in combination 
with a cytotoxic agent.  
• 
Must undergo a pre-treatment tumor biopsy procedure. 
OR 
If available, tumor tissue previously retrieved from a biopsy procedure performed within 2 years prior to the 
subject signing informed consent and that has a minimum of 10 × 4 micron sections or a tissue block 
equivalent of 10 × 4 micron sections may be substituted for the pre-treatment biopsy procedure during 
Screening.  If a documented law or regulation prohibits (or does not approve) sample collection, then such 
samples will not be collected/submitted. 
Note: Results from the TROP2 testing or any other results of the pre-treatment tumor biopsy will not be used 
to determine eligibility for the study.  
• 
Has measurable disease based on local imaging assessment using RECIST v1.1. 
• 
Has an Eastern Cooperative Oncology Group performance status of 0 or 1 at Screening. 
• 
Within 7 days before randomization, has adequate bone marrow function defined as: 

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1. Platelet count ≥100,000/mm3 (platelet transfusion is not allowed within 1 week prior to Screening 
assessment) 
2. Hemoglobin ≥9.0 g/dL (red blood cell/plasma transfusion is not allowed within 1 week prior to 
Screening assessment) 
3. Absolute neutrophil count ≥1500/mm3 (granulocyte-colony stimulating factor [G-CSF] 
administration is not allowed within 1 week prior to Screening assessment). 
(See Section 6.5.2 and Section 6.6 for use of G-CSF and erythropoietin) 
• 
Within 7 days before randomization, has adequate hepatic function defined as: 
1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal 
(ULN) or AST and ALT ≤5.0 × ULN if transferase elevation is due to liver metastases) AND 
2. Total bilirubin ≤1.5 × ULN (or <3.0 × ULN in the presence of documented Gilbert’s syndrome 
[unconjugated hyperbilirubinemia] or liver metastases at baseline).  Note: The Investigator should 
follow local practice guidelines and/or the docetaxel label approved in the country of drug 
administration for assessing eligibility of subjects for the study. 
• 
Within 7 days before randomization, has adequate renal function, including mild or moderate renal function, 
defined as: 
1. Creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation. 
• 
Has left ventricular ejection fraction (LVEF) ≥50% by either echocardiogram (ECHO) or multigated 
acquisition (MUGA) scan within 28 days before randomization.  
• 
Has adequate blood clotting function defined as international normalized ratio/prothrombin time and either 
partial thromboplastin or activated partial thromboplastin time ≤1.5 × ULN. 
• 
Has an adequate treatment washout period before randomization defined as: 
Treatment 
Washout Period 
Major surgery 
≥3 weeks 
Radiation therapy including 
palliative radiation to chest 
≥4 weeks  
≥2 weeks (palliative radiation therapy to other 
areas [ie, limited field and 10 or fewer days or 
fractions] including whole brain radiotherapy) 
Anticancer chemotherapy 
(Immunotherapy 
[non-antibody-based therapy]), 
retinoid therapy 
≥2 weeks or 5 times the terminal elimination half-
life (t1/2) of the chemotherapeutic agent, 
whichever is longer; ≥6 weeks for nitrosoureas or 
mitomycin C; ≥1 week for tyrosine kinase 
inhibitors approved for the treatment of NSCLC-
baseline computed tomography (CT) scan should 
be completed after discontinuation of tyrosine 
kinase inhibitors.  
Antibody-based anticancer 
therapy 
≥4 weeks 
Chloroquine/Hydroxychloroquine 
>14 days 
In Czech Republic only, please see Section 10.9.1 for modified text applicable to sites in Czech Republic. 
 
Key Exclusion Criteria: 
Subjects meeting any exclusion criteria for this study will be disqualified from entering the study.  Below is a list 
limited to the key exclusion criteria: 
• 
Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as 
untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated 
symptoms.  Subjects with clinically inactive brain metastases may be included in the study.  Subjects with 

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treated brain metastases who are no longer symptomatic and who require no treatment with corticosteroids or 
anticonvulsants may be included in the study if they have recovered from the acute toxic effect of 
radiotherapy.  A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and 
study enrollment.  Note: A CT or magnetic resonance imaging (MRI) scan of the brain at baseline is required 
for all subjects.  For those subjects in whom CNS metastases are first discovered at the time of Screening, 
the treating Investigator should consider delay of study treatment to document stability of CNS metastases 
with repeat imaging at least 4 weeks later (in which case, repeat of all Screening activity may be required). 
• 
Has leptomeningeal carcinomatosis or metastasis. 
• 
Had prior treatment with:  
1. Any agent, including antibody-drug conjugate (ADC), containing a chemotherapeutic agent 
targeting topoisomerase I. 
2. TROP2-targeted therapy. 
3. Docetaxel. 
• 
Has uncontrolled or significant cardiac disease, including:  
1. Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) prolongation 
>470 msec (based on the average of Screening triplicate 12-lead electrocardiogram [ECG] 
determinations). 
2. Myocardial infarction or uncontrolled/unstable angina within 6 months before randomization. 
3. Congestive heart failure (CHF) (New York Heart Association Class II to IV) at Screening.  Subjects 
with a history of Class II to IV CHF prior to Screening, must have returned to Class I CHF and have 
LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to 
be eligible. 
4. Uncontrolled or significant cardiac arrhythmia. 
5. LVEF <50% by ECHO or MUGA scan within 28 days before randomization. 
6. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure 
>110 mmHg) within 28 days before randomization. 
• 
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has 
current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. 
• 
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not 
limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months before randomization, 
severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.), 
or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, 
rheumatoid arthritis, Sjogren’s syndrome, sarcoidosis, etc.), or prior pneumonectomy. 
• 
Clinically significant corneal disease. 
• 
Has a history of malignancy, other than NSCLC except a) adequately resected non-melanoma skin cancer, 
b) curatively treated in situ disease, or c) other solid tumors curatively treated, with no evidence of disease 
for ≥3 years. 
• 
Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients 
(including but not limited to polysorbate 80) of DS-1062a or docetaxel.  

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OS will also be analyzed at the primary analysis of PFS (OS IA). The efficacy boundary will be determined using 
a group sequential design with Lan-DeMets procedure with O'Brien Fleming stopping boundary.  It is projected 
that approximately 293 deaths will be observed at the IA, ie, 71% of information fraction (IF, ie, 293 out of the 
target 413 OS events).  The study may be stopped at OS IA if the pre-specified superiority boundary is crossed. 
The study will continue until the required number of deaths (413 OS events) is reached for the primary analysis 
of OS at approximately 33 months after the first subject is randomized. 
Efficacy Analyses 
The primary efficacy analysis of PFS and OS will compare the DS-1062a and docetaxel arms using a stratified 
log-rank test stratified by the randomization stratification factors.  
PFS and OS will be summarized and graphically presented using the Kaplan-Meier method by treatment arm 
with median and corresponding confidence interval (CI) for the median using the Brookmeyer and Crowley 
method.  In addition, the event-free probability at different time points (eg, 3, 6, 9, 12 months) will be estimated 
with corresponding CIs using the Greenwood formula for variance derivation. 
The stratified Cox regression model, stratified by the randomization stratification factors, will be fitted to 
estimate the hazard ratio of PFS and OS between the treatment versus the control arm (docetaxel) and the 
corresponding CI. 
The secondary efficacy endpoints include PFS as assessed by Investigator, overall response rate (ORR), duration 
of response (DoR), disease control rate (DCR), and time to response (TTR), each as assessed by BICR and by 
Investigator per RECIST v1.1.  
PFS as assessed by Investigator will be analyzed in a similar manner as PFS as assessed by BICR. 
The estimate of ORR and its 2-sided 95% exact (Clopper-Pearson) CI will be provided by treatment arm. 
DoR will be analyzed in a similar manner as the primary endpoints, except that a hazard ratio will not be 
generated for DoR. 
The estimate of DCR and its 2-sided 95% exact (Clopper-Pearson) CI will be provided by treatment arm. 
TTR will be summarized descriptively. 
The exploratory efficacy endpoint second progression-free survival (PFS2) will be analyzed in a similar manner 
as PFS. 
Subgroup analyses will be conducted for PFS, OS, ORR, and DoR based on randomization period (before and 
after protocol version 4.0 to include subjects with actionable genomic alterations) as well as by presence of 
actionable genomic alterations (present versus absent).  
Safety Analyses 
Safety analyses, in general, will be descriptive and will be presented in tabular format with summary statistics 
presented by treatment arm for the Safety Analysis Set. 
Pharmacokinetic Analyses 
Plasma concentrations for DS-1062a (antibody-drug conjugate), total anti-TROP2 antibody, and MAAA-1181a 
will be listed, plotted, and summarized using descriptive statistics. The following PK parameters will be 
calculated for each subject in the full PK sampling cohort using non-compartmental analysis of concentration 
time data of DS-1062a, total anti-TROP2 antibody, and MAAA-1181a: maximum plasma concentration, time to 
reach maximum plasma concentration, area under the plasma concentration-time curve up to the last quantifiable 
time, area under the plasma concentration-time curve during dosing interval, and if data permit, area under the 
plasma concentration-time curve up to infinity, t1/2, total body clearance, volume of distribution at steady state, 
volume of distribution based on the terminal phase, and elimination rate constant associated with the terminal 
phase. 
Population PK and exposure-response (ER) analyses will be performed to characterize the relationships of dose, 
exposure, efficacy, and safety endpoints.  The effects of intrinsic (eg, body weight) and extrinsic covariates on 
PK and ER relationship will be evaluated.  The results of the population PK and ER analyses will be reported 
separately from the clinical study report. 

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Immunogenicity 
Immunogenicity will be assessed through characterization of incidence and titer of antidrug antibodies (ADA). 
The number and proportion of subjects having pre-existing ADA at baseline and treatment-emergent ADA will 
be summarized. 
Patient-reported Outcomes 
The Kaplan-Meier method will be used to estimate the distribution of TTD in any of the 3 symptoms, cough, 
chest pain, or dyspnea.  The median TTD along with the 95% CI will be presented by treatment arm. 
Descriptive analysis will be conducted on Patient-reported Outcomes (PRO) score, including subjects in the Full 
Analysis Set without a missing baseline PRO score and at least 1 post-baseline score. 
All PRO instruments will be scored according to their corresponding scoring manual. 
 

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1.2. 
Study Schema 
Figure 1.1: 
Study Level Flow Diagram 
 
AGA = actionable genomic alteration; DoR = duration of response; DCR = disease control rate; ECOG PS = Eastern 
Cooperative Oncology Group performance status; NSCLC = non-small cell lung cancer; OS = overall survival; 
ORR = overall response rate; PFS = progression-free survival; PK = pharmacokinetic; PRO = Patient-reported 
Outcomes; Q3W = every 3 weeks; RECIST v1.1 = Response Evaluation Criteria in Solid Tumors, Version 1.1; 
ROW = rest of world.; TTR = time to response 
a Randomization will be stratified by documented actionable genomic alteration (present versus absent), histology 
(squamous versus nonsquamous), most immediate prior therapy included anti-PD-1/anti-PD-L1 immunotherapy 
(yes versus no), and geographical region (US/Japan/Western Europe versus ROW).  
b Only protocol deviations that are deemed significant by the Investigator with or without consultation with the 
Sponsor may lead to permanent study drug discontinuation. 
c Subjects who discontinue study treatment without radiographic disease progression will continue to undergo tumor 
assessments every 6 weeks (±7 days) during follow-up until radiographic disease progression as assessed by 
Investigator, death, lost to follow-up, or withdrawal of consent.  
Note: Two independent primary endpoints: PFS as assessed by BICR per RECIST v1.1 and OS.  
Secondary endpoints: PFS as assessed by Investigator; ORR, DoR, DCR, and TTR each as assessed by BICR and by 
Investigator per RECIST v1.1; safety; PK; immunogenicity; PRO. 
The primary completion date of progression-free survival (PFS) endpoint is the date when the pre-specified 
number of PFS events as assessed by BICR is reached and at least 4 months after the last subject has been 
randomized. This date is used as the data cutoff (DCO) for the primary analysis of PFS. 
The primary completion date of overall survival (OS) endpoint is the date when the pre-specified number of 
deaths (413 OS events) is reached. This date is used as the DCO for the primary analysis of OS.  
All subjects still on study treatment and continuing to derive benefit at the primary completion date of PFS or OS 
will continue to follow the study Schedule of Events until the overall end of study (EOS) is reached.  
The overall EOS will occur after all subjects have discontinued the study or have died, an alternative study becomes 
available for subjects continuing to derive benefit from treatment with DS-1062a where the drug is offered to these 
subjects, or the study is discontinued by the Sponsor for other reasons.  A final analysis may be conducted at the 
overall EOS. 

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Note: For prevention of oral mucositis/stomatitis, initiate a daily oral care protocol (OCP) (see Section 6.2.1). The importance of multiple daily mouth rinses during treatment (eg, 
prior to dosing) and up to the first follow-up visit should be emphasized. 
Note: For prevention of ocular surface toxicity, it should be strongly recommended that subjects avoid the use of contact lenses starting on the day of the first DS-1062a dose and 
to use artificial tears (preferably preservative-free) 4 times per day as preventative measure and up to 8 times per day as clinically needed. 
Note: Ophthalmologic assessments including visual acuity testing, slit lamp examination, intraocular pressure measurement, fundoscopy, and fluorescein staining will be 
performed at screening, as clinically indicated, and at the EOT visit by an ophthalmologist, or if unavailable, another licensed eye care provider. 

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2. 
INTRODUCTION 
2.1. 
Background 
2.1.1. 
Non-Small Cell Lung Cancer 
Lung cancer is the most common cancer and the leading cause of cancer-related mortality 
worldwide, with an estimated 2.1 million new cases of lung cancer in 2018 (11.6% of all new 
cases) and 1.8 million deaths (18.4% of all cancer deaths) globally based on GLOBOCAN data.1  
Advances in early detection of lung cancer have been slow, and more than half of lung cancers 
are still diagnosed at an advanced stage.2  Only 18.6% of all patients with lung cancer are alive 
5 years or more after diagnosis.3  Non-small cell lung cancer (NSCLC) accounts for 80% to 85% 
of all lung cancers.4  
The introduction of targeted therapies and checkpoint inhibitors in recent years has improved the 
treatment landscape and patients with metastatic NSCLC are now surviving longer.5,6  A number 
of genomic alterations that have an impact on therapy selection have been identified in NSCLC 
and molecular testing is part of the standard of care in the evaluation of NSCLC.6  These include 
epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) 
gene rearrangements, ROS proto-oncogene 1 (ROS1) rearrangements, neurotrophic tyrosine 
receptor kinase (NTRK) gene fusions, and proto-oncogene B-raf (BRAF) point mutations.6 
The expression of programmed cell death ligand 1 (PD-L1) is often assessed to select patients for 
immune checkpoint inhibitors.6  For patients with metastatic NSCLC, negative test results for 
EGFR and ALK, and PD-L1 levels of 50% or more (approximately 27% of patients), the 
National Comprehensive Cancer Network (NCCN) guidelines6 recommend the immune 
checkpoint inhibitor pembrolizumab monotherapy in first-line therapy.  The recommended 
first-line option for patients with metastatic NSCLC, negative or unknown test results for EGFR 
and ALK, and PD-L1 expression levels of 1% to 49% (approximately 32% of patients) depends 
on the background histology: for patients with nonsquamous NSCLC, the standard of care is a 
combination regimen of pembrolizumab plus carboplatin/cisplatin plus pemetrexed based on the 
results from the KEYNOTE-189 study.7  For patients with squamous NSCLC, the standard of 
care is a combination regimen of pembrolizumab plus carboplatin plus paclitaxel (or nab 
paclitaxel) based on results from the KEYNOTE-407 study.8  For patients with less than 1% 
expression of PD-L1, first-line therapy usually includes platinum-based chemotherapy with or 
without immunotherapy.6 
Among patients relapsing or progressing after frontline platinum-containing doublet therapy, the 
Checkmate-017 and -057 studies demonstrated superior OS of nivolumab over docetaxel 
monotherapy in patients with squamous and nonsquamous NSCLC, respectively.9,10  Notably, 
the median progression-free survival (PFS) of the docetaxel control arms were 2.8 months and 
4.2 months, respectively, and the median OS were 6.0 months and 9.4 months, respectively.9,10 
As a result of these and similar studies, patients with NSCLC generally receive platinum 
doublets and immune checkpoint inhibitors, either in combination or in sequence, as the first 1 or 
2 lines of therapy.  None of these therapies, however, are considered curative, and once patients 
have progressed after them, therapeutic options are generally limited to cytotoxic agents 
deployed as monotherapy, and median survival times are less than 1 year.  In the multicenter, 
double-blind, randomized Phase 3 study (REVEL)11 of docetaxel plus ramucirumab or placebo 

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as second-line treatment for patients with Stage IV NSCLC after platinum-based therapy, the 
median OS for patients treated with ramucirumab plus docetaxel versus those treated with 
placebo plus docetaxel was 10.5 months versus 9.1 months, respectively, and the median PFS 
was 4.5 months versus 3.0 months, respectively.10  However, the addition of ramucirumab to 
docetaxel adds significant toxicities and the relevance of the results to a population that has 
failed prior immune checkpoint inhibitors remains unclear.  As such, global usage of 
ramucirumab with docetaxel remains limited, despite broad regulatory approval. 
For patients who have actionable genomic alterations (eg, EGFR, ALK, ROS1, BRAF, MET 
exon 14 skipping, or RET kinase inhibitors), targeted therapies are recommended during the 
course of treatment as systemic treatments for the subset of patients with NSCLC whose tumors 
have driver genomic alterations.  However, once patients have developed acquired resistance to 
the various targeted therapies and platinum-based chemotherapy, there are limited treatment 
options.  
Docetaxel monotherapy remains perhaps the most widely used treatment for patients whose 
NSCLC has progressed after platinum-based chemotherapy and immune checkpoint inhibitors 
(in the case of NSCLC without AGA), or targeted therapies (in the case of NSCLC with AGA), 
consistent with NCCN guidelines.6  The Checkmate 017, Checkmate 057, and REVEL studies 
suggest that these patients have median PFS of 3 months to 4 months and median survival of 
6 months to 9 months.  Therefore, there remains significant unmet need in patients with 
advanced or metastatic NSCLC. 
2.1.2. 
DS-1062a 
Trophoblast cell surface protein 2 (TROP2), also known as tumor-associated calcium signal 
transducer 2, is a 36-kDa single-pass transmembrane protein expressed primarily in a variety of 
epithelial cells.  TROP2 has several binding partners, including claudin 1, claudin 7, cyclin D1, 
protein kinase C, phosphatidylinositol 4,5 biphosphate, and insulin-like growth factor 1.  TROP2 
is highly expressed in various epithelial tumors, including NSCLC.12  TROP-2 expression has 
been correlated with aggressive tumor behavior and has been used as a prognostic factor in 
several types of cancer.12,13,14 
DS-1062a (datopotamab deruxtecan; Dato-DXd) is an antibody-drug conjugate (ADC) that 
comprises a recombinant humanized anti TROP2 immunoglobulin 1 monoclonal antibody, 
MAAP-9001a, which is covalently conjugated to a drug linker, MAAA-1162a, via thioether 
bonds.  The released drug, MAAA-1181a, inhibits DNA topoisomerase I and leads to apoptosis 
of the target cells. To date, there have not been any registrational studies for TROP2-directed 
ADCs in the advanced or metastatic setting for NSCLC. 
2.2. 
Study Rationale 
DS-1062a is a TROP2-targeted antibody and topoisomerase I inhibitor conjugate.  High 
expression levels of TROP2 have been reported in NSCLC15,16 and other solid tumors17 and have 
been shown to indicate a poor prognosis for these patients.12 
DS-1062a showed antitumor activity in both in vitro and in vivo nonclinical studies and a mean 
terminal half-life (t1/2) of 4.62 days (6.0 mg/kg) in humans, which allows a once-every-3-weeks 
(Q3W) dosing schedule.18  

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Clinical data are available from the ongoing Phase 1 first-in-human study, DS1062-A-J101, 
evaluating escalating doses of DS-1062a (0.27 mg/kg to 10.0 mg/kg) in unselected subjects with 
advanced NSCLC relapsed or refractory to standard of care therapy.  As described in the IB,18 
dose-limiting toxicities occurred in 3 subjects:  2 subjects at 10.0 mg/kg (1 subject with Grade 3 
stomatitis and 1 subject with Grade 3 mucosal inflammation), and 1 subject at 6.0 mg/kg 
(Grade 3 maculo-papular rash).  The maximum tolerated dose (MTD) was determined at 
8.0 mg/kg. 
As of the data cutoff (DCO) date of 04 Sep 2020, data are available for 208 subjects treated with 
DS-1062a in the 0.27 mg/kg to 10.0 mg/kg Q3W cohorts, including 50 subjects treated at 
4.0 mg/kg, 46 subjects at 6.0 mg/kg, and 82 subjects at 8.0 mg/kg doses.18  The median duration 
of treatment was 2.76 months (range: 0.7 to 20.0) across all doses; 2.09 months (range: 0.7 to 
20.0) in the 4.0 mg/kg dose group; 2.07 months (range: 0.7 to 19.7 months) in the 6.0 mg/kg 
dose group; and 3.19 months (range: 0.7 to 13.5 months) in the 8.0 mg/kg dose group.  As of the 
DCO, study treatment was ongoing in 72 subjects at the 4.0 mg/kg, 6.0 mg/kg, and 8.0 mg/kg 
dose levels. 
As of the DCO date of 04 Sep 2020, 189 subjects were evaluable for response assessments, 
defined as subjects who received at least 1 dose of DS-1062a and had pre-treatment and at least 
1 post-treatment tumor assessment or discontinued from study treatment.18  The overall response 
rate (ORR) by blinded independent central review (BICR) was 17.5% (7 PR in 40 subjects) in 
the 4.0 mg/kg dose group, 15.4% (6 partial responses [PRs] in 39 subjects) in the 6.0 mg/kg dose 
group, and 23.8% (19 PRs in 80 subjects) in the 8.0 mg/kg dose group.  The disease control rate 
(DCR) was 72.5% (7 PRs and 21 stable diseases [SDs] in 40 subjects) in the 4.0 mg/kg dose 
group, 66.7% (6 PRs and 18 SDs in 39 subjects) in the 6.0 mg/kg dose group, and 80.0% (19 PRs 
and 43 SDs in 80 subjects) in the 8.0 mg/kg dose group.  Results for DS-1062a among NSCLC 
subjects with AGA have become available with a DCO of 06 Apr 2021. The ORR by BICR was 
35.3% (12/34 [95% CI, 19.7-53.5]) among the 34 subjects treated with DS-1062a at doses of 
4, 6, or 8 mg/kg. The overall DCR was 82.4%, and the median DoR was 9.5 months (95% CI, 
3.3-NE) in this subgroup. These results support the inclusion of NSCLC subjects with AGA into 
this Phase 3 study.33 
As of 04 Sep 2020, treatment-emergent adverse events (TEAEs) were reported in 199 (96%) of 
208 subjects, including 48 (96%) of 50 subjects in the 4.0 mg/kg dose group, 42 (91%) of 
46 subjects in the 6.0 mg/kg dose group, and 81 (99%) of 82 subjects in the 8.0 mg/kg dose 
group.18  The most frequent (≥20% of subjects) TEAEs across all doses, all grades, regardless of 
dose and causality were: nausea (47%), stomatitis (39%), fatigue (34%), alopecia (34%), 
decreased appetite (25%), vomiting (23%), and constipation (21%).   
A total of 89 (43%) of 208 subjects experienced at least 1 ≥Grade 3 TEAE regardless of 
causality including 11 (22%) of 50 subjects in the 4.0 mg/kg dose group, 17 (37%) of 46 subjects 
in the 6.0 mg/kg dose group, and 46 (56%) of 82 subjects in the 8.0 mg/kg dose group.  The 
frequency of ≥Grade 3 TEAEs appears to be dose-related (22%, 4.0 mg/kg; 37%, 6.0 mg/kg; and 
56%, 8.0 mg/kg dose group).   
Forty-two (20%) of 208 subjects experienced ≥Grade 3 TEAEs assessed by the Investigator as 
study drug related, including 5 (10%) of 50 subjects in the -4.0 mg/kg dose group, 7 (15%) of 
46 subjects in the 6.0 mg/kg dose group, and 27 (33%) of 82 subjects in the 8.0 mg/kg dose 

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group.18  A dose-related effect was noted with an observed increase in the proportion of subjects 
reporting ≥Grade 3 TEAEs assessed by the Investigator as study drug related with a higher dose 
of DS-1062a compared with the lower dose groups.  The most frequently reported ≥Grade 3 
TEAE (≥5 subjects) assessed by the Investigator as study drug-related across all doses was 
mucosal inflammation (6 subjects [3%]). 
A numeric increase by dose was observed in TEAEs associated with study drug withdrawal, 
reduction, and interruption (4.0 mg/kg compared to 6.0 mg/kg or 8.0 mg/kg).  A total of 
20 (10%) of 208 subjects experienced TEAEs associated with study drug withdrawal, including 
4 (8%) of 50 subjects in the 4.0 mg/kg dose group, 4.0 (9%) of 46 subjects in the 6.0 mg/kg dose 
group, and 12 (15%) of 82 subjects in the 8.0 mg/kg dose group.  The most frequent TEAE 
across all doses leading to study drug withdrawal was pneumonitis (8 subjects [4%]).  A total of 
35 (17%) of 208 subjects experienced TEAEs associated with dose reduction, including 1 (2%) 
of 50 subjects in the 4.0 mg/kg dose group, 4 (9%) of 46 subjects in the 6.0 mg/kg dose group, 
and 25 (31%) of 82 subjects in the 8.0 mg/kg dose group.  The most frequent (≥5 subjects) 
TEAEs associated with dose reduction across all doses were stomatitis (12 subjects [6%]) and 
mucosal inflammation (7 subjects [3%]).  A total of 28 (14%) of 208 subjects experienced 
TEAEs associated with dose interruption including 2 (4%) of 50 subjects in the 4.0 mg/kg dose 
group, 9 (20%) of 46 subjects in the 6.0 mg/kg dose group, and 16 (20%) of 82 subjects in the 
8.0 mg/kg dose group.  The most frequent (≥4 subjects) TEAEs across all doses associated with 
dose interruption were lung infection and pneumonitis (4 subjects [2%] each).   
As of 04 Sep 2020 across all doses, there were 14 subjects (7%) with interstitial lung disease 
(ILD)/pneumonitis events that were independently adjudicated as drug-related: 12 subjects 
(15%) on 8.0 mg/kg, 1 subject (2%) on 6.0 mg/kg, and 1 subject (2%) on 4.0 mg/kg.  Of the 
14 subjects with events adjudicated as drug-related ILD, 3 (1%) who had Grade 5 events; these 
3 subjects were in the 8.0 mg/kg dose group.  
Across all doses, 40 (19%) of 208 subjects treated have experienced TEAEs of infusion-related 
reaction.18  All events of infusion-related reaction, were Grade 1 or Grade 2 except for 2 Grade 3 
events (1 at 4.0 mg/kg and 1 at 6.0 mg/kg).  All occurred during Cycle 1 or 2 of study treatment 
and were manageable.  
ILD/pneumonitis is an important identified risk for DS-1062a.  Other identified risks include 
IRR, fatigue, anaemia, stomatitis/mucosal inflammation, diarrhoea, nausea, decreased appetite, 
alopecia, vomiting, dry eye, and rash/rash maculopapular. Potential risks include keratitis, skin 
pigmentation, AST increased, ALT increased, and constipation.  Adverse events of special 
interest (AESIs) include ILD/pneumonitis, stomatitis/mucosal inflammation, infusion-related 
reaction, and ocular surface toxicity.  Established treatment guidelines are in place to manage 
these and other toxicities associated with DS-1062a.   
Refer to the most recent IB for additional DS-1062a information.18 
There is a significant unmet medical need for patients with advanced or metastatic NSCLC after 
receiving platinum-based chemotherapy and an α (anti)-programmed cell death 1 
(PD-1)/α-PD-L1 monoclonal antibody (patients without actionable genomic alterations) or with 
additional lines of target therapy specific to actionable genomic alterations (patients with 
actionable genomic alterations).  DS-1062a has the potential to offer a treatment option for 
patients with advanced or metastatic NSCLC with and without actionable genomic alterations.  

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This Phase 3 study will be conducted to evaluate the efficacy and safety of DS-1062a versus 
control treatment with docetaxel in this population.  Docetaxel is a microtubule inhibitor that is 
approved globally as a single agent for the treatment of locally advanced or metastatic NSCLC 
after failure of prior platinum-based chemotherapy.6,9,10,19,20,21 
2.3. 
Benefit and Risk Assessment 
A total of 208 subjects have been treated with DS-1062a in the ongoing DS1062-A-J101 Phase 1 
study.18  Data from this study show efficacy across dose groups with tumor responses observed 
at starting doses of 4.0-, 6.0-, and 8.0-mg/kg and an acceptable and manageable toxicity profile.  
As of the DCO date of 04 Sep 2020, DS-1062a has demonstrated response rates across these 
3 dose cohorts with confirmed and durable responses as described in Section 2.2. 
Based on cumulative review of safety data, important identified risks for DS-1062a are 
ILD/pneumonitis.  Other identified risks include IRR, fatigue, anaemia, stomatitis/mucosal 
inflammation, diarrhoea, nausea, decreased appetite, alopecia, vomiting, dry eye, and rash/rash 
maculopapular.  The potential risks include keratitis, skin pigmentation, AST increased, ALT 
increased, and constipation. 
The identified/potential risks have been generally manageable through dose modification and 
routine clinical practice.  As with any therapeutic antibodies, there is a possibility of IRRs and 
immune responses causing allergic or anaphylactic reactions of DS-1062a. 
In the DS-1062a clinical program, inclusion/exclusion criteria and monitoring/management 
guidelines are currently included in the study protocols to mitigate the identified and potential 
risks of DS-1062a, including the important identified risk of ILD/pneumonitis.  
Potential ILD cases are monitored closely for signs/symptoms of ILD and reviewed by an 
independent ILD Adjudication Committee (AC) established for the DS-1062a program.  The 
study protocols include detailed dose modification and supportive care guidelines for the 
proactive management of ILD.  In the ongoing DS1062-A-J101 Phase 1 study, the majority of 
drug-induced ILD occurred at 8.0 mg/kg. 
Infusion-related reactions are also monitored closely in the DS-1062a clinical program.  Protocol 
eligibility criteria excluding potential subjects with a history of hypersensitivities reaction to any 
of the DS-1062a excipients, guidance on required premedication, and detailed dose modification 
guidelines are provided to mitigate the risk of IRR.  In the ongoing DS1062-A-J101 Phase 1 
study, all observed IRR, except for one Grade 3 event, have been mild or moderate, and 
manageable by close observation and dose modification.  
Overall, the DS-1062a safety profile remains acceptable and manageable and supports continued 
clinical development of DS-1062a in NSCLC.  Ongoing review of emerging Phase 1 study data 
has allowed a closer evaluation of benefit:risk by dose.  Based on the most recent review of 
safety and efficacy data, DS-1062a is less tolerated at the 8.0 mg/kg dose compared to the 
4.0 mg/kg and 6.0 mg/kg doses, and thus, 8.0 mg/kg is not an optimal dose for further 
evaluation.  In addition, DS-1062a at the 6.0 mg/kg dose has a more favorable benefit:risk profile 
compared with that of the 8.0 mg/kg and 4.0 mg/kg doses, respectively.  Subject to continual 
review of emerging data, current evaluation of benefit:risk supports the selection of 6.0 mg/kg as 
the optimal dose for further development of DS-1062a in patients with advanced or metastatic 
NSCLC. 

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For additional information on justification for dose selected in this study, see Section 4.3. 
2.3.1. 
Benefit-Risk in Regard to COVID-19 
With the emergence of the Coronavirus disease 2019 (COVID-19) comes an increased safety 
risk for all subjects.  As a result of the potential impact of COVID-19 on the lung, the Sponsor 
has developed a monitoring plan to limit and manage the potential risk of COVID-19 to 
DS-1062a and docetaxel study subjects.  For any subjects with suspected or confirmed 
COVID-19, study treatment will be delayed until they fully recover for treatment resumption (as 
outlined in the dose modification guidance; Section 6.5).  All clinical study protocols have been 
updated to include language on dose modification for COVID-19. 
As the subjects included in this study are at high risk of recurrence, and improved therapies are 
still needed for this population, the Sponsor considers the potential benefit of DS-1062a for 
subjects in this study outweighs any potential risks associated with COVID-19. 

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ADA = antidrug antibody; AE = adverse event; AESI = adverse event of special interest; AUCinf = area under the 
plasma concentration-time curve up to infinity; AUClast = area under the plasma concentration-time curve up to the 
last quantifiable time; AUCtau = area under the plasma concentration-time curve during dosing interval; 
BICR = blinded independent central review; BOR = best overall response; CBR = clinical benefit rate; CL = total 
body clearance; Cmax = maximum plasma concentration; CR = complete response; DCR = disease control rate; 
DoR = duration of response; ECG = electrocardiogram; ECHO = echocardiogram; ECOG PS = Eastern Cooperative 
Oncology Group performance status; EORTC-QLQ-C30 = European Organisation for Research and Treatment of 
Cancer Quality of Life Questionnaire Core 30; EORTC-QLQ-LC13 = European Organisation for Research and 
Treatment of Cancer Quality of Life Lung Cancer 13; EQ-5D-5L = EuroQol Questionnaire- 5 dimensions-5 levels; 
Kel = elimination rate constant associated with the terminal phase; MAAA-1181a = released drug; 
MedDRA = Medical Dictionary for Regulatory Activities; MUGA = multigated acquisition; 
NCI-CTCAE = National Cancer Institute - Common Terminology Criteria for Adverse Events; NSCLC = non-small 
cell lung cancer; ORR = overall response rate; OS = overall survival; PFS = progression-free survival; 
PFS2 = second progression-free survival; PK = pharmacokinetics; PR = partial response; PRO = Patient-reported 
Outcomes; PRO-CTCAE = Patient-reported Outcomes version of the Common Terminology Criteria for Adverse 
Events; RECIST v1.1 = Response Evaluation Criteria in Solid Tumors version 1.1; SAE = serious adverse event; SD 
= stable disease; t1/2 = terminal half-life; TEAE = treatment-emergent adverse event; Tmax = time to reach 
maximum plasma concentration; TROP2 = trophoblast cell surface protein 2; TTD = time to deterioration; TTR = 
time to response; Vss = volume of distribution at steady-state; Vz = volume of distribution based on the terminal 
phase 
3.1. 
Rationale for Selection of Primary and Secondary Endpoints 
This study has 2 independent primary endpoints of OS and PFS.  The study will be considered 
positive if the hypothesis test for either one of these primary endpoints is successful.  
PFS is a relevant measure of clinical benefit for a randomized Phase 3 trial that demonstrates 
superiority of a new antineoplastic therapy, especially if the magnitude of effect is large and the 
therapy has an acceptable risk-benefit profile.22  PFS is also not confounded by subsequent 
therapies and is a direct measure of therapeutic agent’s direct benefit.  
Historically, OS is a clinically meaningful and direct measure of overall efficacy in incurable, 
metastatic NSCLC disease and is considered the gold standard. The majority of drug approvals 
for NSCLC have been based on a significant improvement in OS.22  However, it can take longer 
to read and potentially can be confounded by the use of subsequent therapies in this setting.  
Hence for study DS1062-A-U301, both PFS and OS will serve as 2 independent endpoints.  
The secondary endpoints described in Table 3.1 are intended to further assess antitumor activity 
of the study treatments, both radiographically and in terms of patient symptomatology. 

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4. 
STUDY DESIGN 
4.1. 
Overall Design 
This is a global, multicenter, randomized, active-controlled open-label Phase 3 study designed to 
evaluate the efficacy, safety, and pharmacokinetics (PK) of DS-1062a versus docetaxel in 
subjects with advanced or metastatic NSCLC with or without actionable genomic alterations (ie, 
alterations in genes with approved therapies, such as EGFR, ALK, ROS1, NTRK, BRAF, MET 
exon 14 skipping or RET).  
Subjects without actionable genomic alterations must have been previously treated with 
platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody, either in combination 
or sequentially.  Patients who received α-PD-1/α-PD-L1 monoclonal antibody as frontline 
therapy may have received the combination of platinum-based chemotherapy and 
α-PD-1/α-PD-L1 monoclonal antibody in the second-line setting.  Subjects with known KRAS 
mutations, in the absence of any driver genomic alterations, are eligible and must meet the prior 
therapy requirements for subjects without actionable genomic alterations.  
Subjects with known actionable genomic alterations must have progressed on or after a 
platinum-containing therapy and 1-2 prior lines of approved targeted therapy for the applicable 
genomic alteration.  The study population is described in Section 5. 
The primary objective of the study is to compare the efficacy of DS-1062a with that of docetaxel 
and demonstrate superiority in terms of either PFS or OS for subjects with NSCLC with or 
without actionable genomic alterations previously treated with platinum-based chemotherapy 
and at least one prior line of therapy as detailed in Section 5. 
PFS as assessed by BICR per Response Evaluation Criteria in Solid Tumors, Version 1.1 
(RECIST v1.1) and OS are the 2 independent primary endpoints of the study.  The study will be 
considered positive if the hypothesis test for either one of the 2 primary endpoints is successful. 
The study will be conducted at approximately 190 study sites predominantly located in North 
America, South America, Europe, Australia, and Asia.  
The study start date is the date when the first subject has signed an informed consent form (ICF).  
A subject is eligible to be randomized into the study when the Investigator or designee has 
obtained written informed consent, has confirmed all inclusion and exclusion criteria have been 
met by the subject, and all Screening procedures have been completed.   
A study level flow diagram is presented in Figure 1.1.  
4.1.1. 
Design Overview 
A total of approximately 590 eligible subjects will be randomized to the DS-1062a arm or 
docetaxel arm in a 1:1 ratio (295/arm), stratified by documented actionable genomic alteration 
(present versus absent), histology (squamous versus nonsquamous), most immediate prior 
therapy included anti-PD-1/anti-PD-L1 immunotherapy (yes versus no) and geographical region 
(United States [US]/Japan/Western Europe versus rest of world [ROW]). A minimum of 15% of 
the total study population will comprise subjects with actionable genomic alterations. No 
crossover between study treatment arms will be allowed. 

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The study will include subjects who have advanced or metastatic NSCLC with and without 
actionable genomic alterations (ie, alterations in genes with approved therapies, such as EGFR, 
ALK, ROS1, NTRK, BRAF, MET exon 14 skipping or RET). Subjects without actionable 
genomic alterations must have been previously treated with platinum-based chemotherapy and 
α-PD-1/α-PD-L1 monoclonal antibody, either in combination or sequentially.  Patients who 
received α-PD-1/α-PD-L1 monoclonal antibody as frontline therapy may have received the 
combination of platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody in the 
second-line setting.  Subjects with known actionable genomic alterations must have progressed 
on or after 1 platinum-containing therapy and 1-2 prior lines of approved targeted therapy for the 
applicable genomic alteration.  Subjects with known KRAS mutations, in the absence of any 
driver genomic alterations, are eligible and must meet the prior therapy requirements for subjects 
without actionable genomic alterations.  See washout period for prior treatments in Section 5.1. 
The study will be divided into 3 periods: Screening Period, Treatment Period, and Follow-up 
Period (which includes the Long-term Survival Follow-up [LTSFU]): 
• The Screening Period will start on the day of signing the ICF and have a maximum 
duration of 28 days.  Rescreening is permitted 1 time.  During the 28-day Screening 
Period, subjects’ eligibility will be confirmed.  Subjects will undergo medical history 
evaluation, physical examination, vital signs determination, laboratory tests, 
electrocardiogram (ECG), echocardiogram (ECHO) or multigated acquisition 
(MUGA) scan, ophthalmologic assessment, and tumor biopsy procedure.  A tumor 
tissue previously retrieved from a biopsy procedure performed within 2 years prior to 
the subject signing informed consent may be substituted for the pre-treatment biopsy 
procedure during Screening.   
• The genomic alteration status of tumors will be addressed as follows:  
− Subjects without actionable genomic alterations must have documented negative 
results for EGFR and ALK genomic alterations for inclusion in the study. If test 
results for EGFR and ALK are not available from subject’s medical history, 
subjects are required to undergo testing performed locally for these genomic 
alterations during Screening.  For the rare ROS1, NTRK, and BRAF, MET exon 
14 skipping, and RET genomic alterations, if the tumor genomic status is 
unknown, it will be assumed the tumor is wild type for these genes (see 
Section 8.1). 
− Subjects with actionable genomic alterations must have one or more documented 
actionable genomic alteration(s) in EGFR, ALK, ROS1, NTRK, BRAF, MET 
exon skipping, or RET for inclusion in the study as a subject with AGA. 
• Eligible subjects will be randomized and enter the Treatment Period.  The Treatment 
Period starts on Cycle 1 Day 1 and continues until a subject permanently discontinues 
DS-1062a or docetaxel.  Note: Dosing must occur within 3 days of randomization if 
all eligibility criteria are met.  During the Treatment Period, eligible subjects will 
receive DS-1062a or docetaxel until they meet 1 of the discontinuation criteria (see 
Section 7.1).  Subjects will continue to receive DS-1062a or docetaxel in the absence 
of radiographic disease progression, clinical progression, unacceptable toxicity, 
withdrawal of consent by subject, physician decision, protocol deviation, pregnancy, 

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lost to follow-up, study termination by the Sponsor, death, or other reasons.  Subjects 
will undergo radiographic assessment of tumor response based on RECIST v1.1 every 
6 weeks (±7 days) from randomization until radiographic disease progression as 
assessed by Investigator, death, lost to follow-up, or withdrawal of consent.  Subjects 
who discontinue treatment without radiographic disease progression or start new 
anticancer therapy without radiographic disease progression will continue to undergo 
tumor assessments every 6 weeks (±7 days) until radiographic disease progression as 
assessed by Investigator, death, lost to follow-up, or withdrawal of consent.   
• The Follow-up Period will start upon permanent discontinuation of DS-1062a or 
docetaxel.  During the Follow-up Period, subjects will be followed for 28 days 
(+7 days) for safety.  After discontinuation of study drug, subjects will then enter the 
LTSFU, during which they will be followed every 3 months for collection of 
information on subsequent anticancer treatment and survival, including the cause and 
date of death.  During LTSFU, subjects who discontinued treatment without 
radiographic disease progression or started new anticancer therapy without 
radiographic disease progression will continue to undergo tumor assessments every 
6 weeks (±7 days) until radiographic disease progression as assessed by Investigator, 
death, lost to follow-up, or withdrawal of consent.  One additional tumor assessment 
performed at 6 weeks (±7 days) after Investigator-assessed radiographic disease 
progression will also be required (if BICR has not determined radiographic disease 
progression). 
• To ensure accurate survival data are available at the time of any database lock, 
updated survival status may be requested during the course of the study by the 
Sponsor. For example, updated survival status may be requested prior to, but not 
limited to, an IDMC review. Upon Sponsor notification, all subjects who do not/will 
not have a scheduled study visit or study contact during the sponsor-defined period 
will be contacted for their survival status (excluding subjects who have a previously 
recorded death event in the collection tool). 
Radiographic imaging scans will be sent to a central imaging vendor for BICR assessment.  If 
BICR has not determined radiographic disease progression by the time of the 1 additional tumor 
assessment performed at 6 weeks (±7 days) after Investigator-assessed radiographic disease 
progression, then sites will retrieve and send subject radiographic scans that are performed as 
part of local standard clinical practice to the central vendor.  The Sponsor will notify the site to 
stop sending further scans to the central vendor when BICR determines radiographic disease 
progression OR until 7 months after the date of Investigator-assessed radiographic disease 
progression for the subject, whichever occurs first.  If BICR determines radiographic disease 
progression before the Investigator, sites will not be notified to stop sending scans until the 
Investigator determines radiographic disease progression.  It is recommended that sites continue 
to follow a scanning interval frequency of every 6 weeks (±7 days) during the standard of 
practice follow-up of the subject as long as it is not interfering with the subject’s standard of 
care.  For further instructions, refer to the Imaging Site Manual which will be provided to the 
site. 
The results of BICR assessment of the subject scans will not be shared with the site or 
Investigator.  The Investigator will manage the subject and make treatment decisions based 

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solely on Investigator/local assessment.  The results of BICR-assessed tumor response will be 
used for the primary analysis of PFS in the study (see Section 3). 
The PK of DS-1062a will be evaluated in all subjects who receive DS-1062a; see Section 8.5.  
Approximately 20 subjects receiving to-be-marketed material of DS-1062a will partake in full 
PK sampling.  All other subjects receiving DS-1062a will partake in sparse PK sampling. 
A potential companion diagnostic assay to analyze TROP2 expression may be developed as part 
of the DS-1062a program.  Depending on the results of biomarker association with clinical 
benefit, a companion diagnostic assay may be developed in the course of this study.  
The Schedules of Events are presented in Table 1.1 (Screening and Cycles 1 through 3 of 
Treatment Period) and Table 1.2 (Cycle 4 onwards, End of Treatment [EOT], and the Follow-up 
Period).  The primary analysis for PFS will be performed when approximately 425 PFS events 
by BICR assessment have been reached and at least months after the last subject has been 
randomized.  The primary analysis of PFS is projected to be approximately 23 months after the 
first subject is randomized. 
OS will also be analyzed at the primary analysis of PFS (OS interim analysis [IA]).  The efficacy 
boundary will be determined using a group sequential design with Lan-DeMets procedure with 
O'Brien Fleming stopping boundary.  It is projected that approximately 293 deaths will be 
observed at the IA.  The study may be stopped at the OS IA if the pre-specified superiority 
boundary is crossed. 
The study will continue until the required number of deaths, approximately 413 OS events, is 
reached for the primary analysis of OS at approximately 33 months after the first subject is 
randomized.   
4.1.2. 
Study Completion 
The primary completion date of the PFS endpoint is the date when the pre-specified number of 
PFS events as assessed by BICR is reached and at least 4 months after the last subject has been 
randomized.  This date is used as the DCO for the primary analysis of PFS. 
The primary completion date of OS endpoint is the date when the pre-specified number of 
deaths (413 OS events) is reached.  This date is used as the DCO for the primary analysis of OS.  
All subjects still on study treatment and continuing to derive benefit at the primary completion 
date of PFS or OS will continue to follow the study Schedule of Events until the overall EOS is 
reached.   
The overall EOS will occur after all subjects have discontinued the study or have died; or an 
alternative study becomes available for subjects continuing to derive benefit from treatment with 
DS-1062a where the drug is offered to these subjects; or the study is discontinued by the Sponsor 
for other reasons.  A final analysis may be conducted at the overall EOS. 
4.1.3. 
Dose Regimen 
4.1.3.1. 
DS-1062a 
DS-1062a will be administered as an intravenous (IV) infusion once Q3W on Day 1 of 21-day 
cycles at a dose of 6.0 mg/kg.  Premedication is required prior to any dose of DS-1062a and must 

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include antihistamines and acetaminophen with or without glucocorticoids.  
 
 
Subjects will continue to receive DS-1062a in the absence of radiographic disease progression as 
assessed by Investigator, clinical progression, unacceptable toxicity, withdrawal of consent by 
subject, physician decision, protocol deviation, pregnancy, lost to follow-up, study termination 
by the Sponsor, death, or other reasons (see Section 7.1).  See Table 6.1 for complete details on 
dose regimen. 
Up to 3 dose reductions will be permitted for subjects.  The adjustment for reduced dosing of 
DS-1062a is as shown in Table 6.3.  Once the dose of DS-1062a is reduced, no dose 
re-escalation is permitted.  
4.1.3.2. 
Docetaxel 
Docetaxel will be administered as an IV infusion of 75 mg/m2 over approximately 60 minutes on 
Day 1 of each 3-week cycle.  Subjects should be premedicated with oral corticosteroids, such as 
dexamethasone 16.0 mg per day (for example, 8.0 mg twice a day) for 3 days starting 1 day prior 
to docetaxel administration, in order to reduce the incidence and severity of fluid retention as 
well as the severity of hypersensitivity reactions.  Additional antiemetic premedication may be 
used at the discretion of the Investigator. 
Subjects will continue to receive docetaxel in the absence of radiographic disease progression as 
assessed by Investigator, clinical progression, unacceptable toxicity, withdrawal of consent by 
subject, physician decision, protocol deviation, pregnancy, lost to follow-up, study termination 
by the Sponsor, death, or other reasons (see Section 7.1).  See Table 6.2 for complete details on 
dose regimen. 
For dose delay and dose modification guidelines for docetaxel, see Section 6.5.2. 
Investigators should consult the locally approved manufacturer’s instructions for docetaxel for 
complete prescribing information (including warnings, precautions, contraindications, and 
adverse reactions) and follow institutional procedures for the administration of docetaxel.19  For 
instructions for storage and docetaxel infusion preparation, consult the study Pharmacy Manual. 
4.1.4. 
Duration 
Study duration is inclusive of 3 periods: Screening Period, Treatment Period, and Follow-up 
Period (which includes the LTSFU) as shown in Figure 1.1. 
The duration of the Screening Period is up to 28 days, which starts on the day of the signing of 
the main informed consent form.  Only eligible subjects who have completed all Screening 
procedures and meet all study entry criteria (defined in Section 5.1 and Section 5.2) will be 
randomized to receive either DS-1062a at 6.0 mg/kg or docetaxel at 75 mg/m2. 
Duration of Treatment and Subject Participation 
Subjects will continue to receive DS-1062a or docetaxel in the absence of radiographic disease 
progression as assessed by Investigator, clinical progression, unacceptable toxicity, withdrawal 
of consent by subject, physician decision, protocol deviation, pregnancy, lost to follow-up, study 
termination by the Sponsor, death, or other reasons (see details in Section 7.1).  Note: Only 
CCI

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protocol deviations that are deemed significant by the Investigator, with or without consultation 
with the Sponsor, may lead to permanent study drug discontinuation. 
In the event of early termination of the study, the Sponsor will consider providing DS-1062a to 
subjects who benefit from treatment according to legal regulations in the corresponding 
countries.  Alternatively, these subjects may also be treated with standard of care per 
Investigator’s decision. 
Overall Study Duration 
Enrollment is planned to occur over a period of approximately 19 months, with treatment and 
follow-up (28-day Safety Follow-up and LTSFU) projected to continue for approximately 
24 months after the last subject is randomized.  The study will continue until the overall EOS is 
reached for the final analysis in the study.  The anticipated total duration of the study is 
approximately 43 months.  
See Section 4.1 for the definition of study start and Section 4.1.2 for the definition of the overall 
EOS. 
Study Drug Continuation After the End of Study 
Not applicable. 
China Extension Study 
If the country-level enrollment target for China that is required by the Chinese regulatory 
authority has not been achieved (approximately 90 subjects) when enrollment in the global study 
is complete, enrollment in China will continue until the required number of subjects are 
randomized.  A minimum of 15% of the total number of subjects enrolled in China will be 
comprised of subjects with actionable genomic alterations as defined in the eligibility criteria of 
the study (Section 5).  Subjects in the China extension study who are enrolled prior to 
completion of global enrollment will be randomized using the following 4 stratification factors: 
documented actionable genomic alteration (present versus absent), histology (squamous versus 
nonsquamous), most immediate prior therapy included α-PD-1/α-PD-L1 immunotherapy (yes 
versus no), and geographical region (US/Japan/Western Europe versus ROW).  Subjects in the 
China extension study who are enrolled after completion of global enrollment will be 
randomized using 3 stratification factors: documented actionable genomic alteration (present 
versus absent), histology (squamous versus nonsquamous) and most immediate prior therapy 
included α-PD-1/α-PD-L1 immunotherapy (yes versus no).  Subjects randomized after global 
enrollment ends will not be included in the planned analysis of the global study. 
4.2. 
Rationale for Study Design 
This is a global, multicenter, randomized, active-controlled, open-label Phase 3 study designed to 
evaluate the efficacy and safety of DS-1062a versus docetaxel in subjects with advanced or 
metastatic NSCLC with or without actionable genomic alterations.  Subjects without actionable 
genomic alterations must have been previously treated with platinum-based chemotherapy and 
α-PD-1/α-PD-L1 monoclonal antibody, either in combination or sequentially.  Subjects with 
known actionable genomic alterations must have progressed on or after 1 platinum-containing 

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therapy and 1-2 prior lines of approved targeted therapy for the applicable genomic alteration.  
The study is designed to address the unmet need of patients with advanced or metastatic NSCLC 
whose disease has relapsed or progressed following standards of care in initial lines of therapy. 
Docetaxel monotherapy is the active comparator treatment in this study and remains perhaps the 
most widely used treatment for NSCLC patients whose disease has progressed after 
platinum-based chemotherapy and immune checkpoint inhibitors (in the case of NSCLC without 
AGA) or targeted therapies (in the case of NSCLC with AGA), consistent with NCCN 
guidelines.6  The Checkmate 017, Checkmate 057, and REVEL studies suggest that these 
patients face a median PFS of 3 months to 4 months and median overall survival of 6 months to 
9 months with standard treatment docetaxel.  Therefore, there remains an area of significant 
unmet need in patients with advanced or metastatic NSCLC.  Available aggregate clinical data 
for DS-1062a support the hypothesis that this drug will improve outcomes relative to docetaxel 
and present a new standard of care for these patients.   
The primary objective of the study is to compare the efficacy of DS-1062a with that of docetaxel 
and demonstrate superiority in terms of either PFS or OS for subjects with NSCLC with or 
without actionable genomic alterations previously treated with platinum-based chemotherapy 
and α-PD-1/α-PD-L1 monoclonal antibody (subjects without actionable genomic alterations) or 
with platinum-based chemotherapy and additional lines of target therapy specific to the 
actionable genomic alteration (subjects with actionable genomic alterations). 
Eligible subjects will be randomized in a 1:1 ratio to DS-1062a 6.0 mg/kg or docetaxel 
75 mg/m2.  Randomization will be stratified by documented actionable genomic alteration 
(present versus absent), histology (squamous versus nonsquamous), most immediate prior 
therapy included anti-PD-1/anti-PD-L1 immunotherapy (yes versus no) and geographical region 
(US/Japan/Western Europe versus ROW).  DS-1062a will be administered as an IV infusion 
Q3W on Day 1 of 21-day cycles at a dose of 6.0 mg/kg.  Docetaxel will be administered as an IV 
infusion of 75 mg/m2 over approximately 60 minutes on Day 1 of each 3-week cycle.  No 
crossover between study treatment arms will be allowed.  
The 1:1 randomization is a clear standard that provides best odds of balance in baseline 
demographic and disease features and that compares DS-1062a and the control arm in a 
scientifically rigorous fashion.  Stratification factors were chosen to address potential treatment 
effects by actionable genomic alteration status, histology, significant regional differences in first 
and second-line therapies and likely differences in post-study salvage therapies, and control for 
variability that may emerge based on prior therapies. 
PFS as assessed by BICR per RECIST v1.1 and OS are the 2 independent primary endpoints of 
the study.  The study will be considered positive if the hypothesis test for either one of these 
primary endpoints is successful. 
PFS is a relevant measure of clinical benefit for a randomized Phase 3 trial that demonstrates 
superiority of a new antineoplastic therapy, especially if the magnitude of effect is large and the 
therapy has an acceptable risk-benefit profile.22  PFS is also not confounded by subsequent 
therapies and is a direct measure of therapeutic agent’s direct benefit.  OS is a clinically 
meaningful and direct measure of overall efficacy in incurable, metastatic NSCLC disease and is 
considered the gold standard.  The majority of drug approvals for NSCLC have been based on a 

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significant improvement in OS.22  However, it can take longer to read and potentially can be 
confounded by the use of subsequent therapies in this setting.  
The secondary endpoints described in Section 3 are intended to further assess antitumor activity 
of the study treatments, both radiographically and in terms of patient symptomatology. 
The rationale for dose selection is in Section 4.3 and the rationale for selection of the primary 
efficacy endpoints is presented in Section 3.1. 
4.3. 
Justification for Dose 
DS-1062a 
The 6.0 mg/kg dose of DS-1062a was selected based on preliminary results of the ongoing 
first-in-human Phase 1 study DS1062-A-J101 which has enrolled approximately 210 subjects 
with NSCLC across a DS-1062a dose range of 0.27 mg/kg to 10 mg/kg.  In this study, DS-1062a 
has shown a generally tolerable safety profile in subjects with NSCLC across a DS-1062a dose 
range of 0.27 mg/kg to 8.0 mg/kg.  The non-tolerated dose for DS-1062a was 10.0 mg/kg where 
2 subjects had Grade 3 dose-limiting toxicities of mucosal inflammation and stomatitis.  
One subject at 6.0 mg/kg had a dose-limiting toxicity of Grade 3 maculo-papular rash.  The 
MTD was reached at 8.0 mg/kg.  Enrollment was expanded to include 50, 50, and 80 subjects at 
doses of 4.0, 6.0, and 8.0 mg/kg, respectively, to enrich the data for the part of the dose:response 
relationship where benefit:risk balance is most delicate.  
As of the DCO date of 04 Sep 2020, data are available for 208 subjects treated with DS-1062a in 
the 0.27 mg/kg to 10.0 mg/kg Q3W cohorts.18  Out of 189 response-evaluable subjects (defined 
as having at least 1 dose of DS-1062a and at least 1 post-baseline tumor assessment or 
discontinued treatment), the ORR by BICR was 17.5% (7 PRs in 40 subjects) in the 4.0 mg/kg 
dose group, 15.4% (6 PRs in 39 subjects) in the 6.0 mg/kg dose group, and 23.8% (19 PRs in 
80 subjects) in the 8.0 mg/kg dose group.  The DCR was 72.5% (7 PRs and 21 SDs in 
40 subjects) in the 4.0 mg/kg dose group, 66.7% (6 PRs and 18 SDs in 39 subjects) in the 
6.0 mg/kg dose group, and 80.0% (19 PRs and 43 SDs in 80 subjects) in the 8.0 mg/kg dose 
group. 
As of 04 Sep 2020, TEAEs were reported in 96% of subjects; 43% of subjects had TEAEs 
≥Grade 3 and serious TEAEs occurred in 34% of subjects.18  The most frequent (≥20% of 
subjects) TEAEs, all grades, regardless of dose and causality were: nausea (47%), stomatitis 
(39%), fatigue (34%), alopecia (34%), decreased appetite (25%), vomiting (23%), and 
constipation (21%).  Twenty-eight subjects (14%) and 35 subjects (17%) had TEAEs that are 
associated with dose interruption or dose reduction, respectively, and 20 subjects (10%) had a 
TEAE that are associated with discontinuation of study treatment. 
DS-1062a has an important identified risk of ILD/pneumonitis that can have a life-threatening or 
fatal outcome.18  As of the 04 Sep 2020 IB cutoff date, 3 cases with a fatal outcome have been 
reported, all of which occurred in the 8.0 mg/kg dose group.  The drug-related adjudicated ILD 
events occurred more frequently in the 8.0 mg/kg dose group where these TEAEs also resulted in 
the highest rate of study drug withdrawals due to ILD.  Dose modification treatment guidelines 
are in place to address toxicity.  For details, see Section 6.5.1. 

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Infusion-related reactions are classified as an identified risk.  A majority of infusion-related 
reaction events were mild or moderate in severity, occurred during Cycle 1 or 2 of study 
treatment and were manageable (Study DS1062-A-J101).  One subject did develop a Grade 3 
anaphylaxis TEAE during infusion, which resolved without sequelae with intervention. 
Based on available safety and efficacy data and a relative evaluation of benefit:risk by dose level, 
DS-1062a is less tolerated at the 8.0 mg/kg dose compared with the 4.0 and 6.0 mg/kg doses, and 
thus, 8.0 mg/kg is not an optimal dose for further evaluation.  While the safety data show that 
DS-1062a is relatively well tolerated at both the 4.0 and 6.0 mg/kg doses and there is evidence 
that DS-1062a is active in NSCLC at both doses, better efficacy is observed at 6.0 mg/kg 
compared with 4.0 mg/kg in the context of an acceptable toxicity profile.   
The most recent review of safety and efficacy data support selection of 6.0 mg/kg as the dose for 
further evaluation in the randomized Phase 3 study.  The Phase 1 study DS1062-A-J101 is 
ongoing and data are continually emerging.  Barring any substantial changes in the efficacy and 
safety profiles of the 4.0 mg/kg and 6.0 mg/kg doses with more mature data, 6.0 mg/kg is the 
optimal dose for DS-1062a monotherapy studies in NSCLC. 
With respect to the dosing schedule, the mean terminal half-life of DS-1062a was 4.84 days at 
the 6.0 mg/kg dose in clinical studies, thus supporting a Q3W dosing schedule. 
Docetaxel 
The docetaxel starting dose of 75 mg/m2 Q3W as a standard therapy in the second-line setting for 
NSCLC was established in the 2 Phase 3 studies TAX 317 and TAX 320.23,24  Additional 
information can be found in the locally approved docetaxel package insert.19 

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5. 
STUDY POPULATION 
The study population includes adult subjects with advanced or metastatic NSCLC with or 
without actionable genomic alterations, as per the inclusion and exclusion criteria described 
below.  
Note: The Investigator should follow local practice guidelines and/or the docetaxel label 
approved in the country of drug administration for assessing eligibility of subjects for the study. 
5.1. 
Inclusion Criteria 
Subjects must meet all of the following criteria to be eligible for the study within 28 days before 
randomization into the study: 
1. Has the ability to provide written informed consent by signing and dating the ICF prior to the 
start of any study-specific qualification procedures. 
2. Adults ≥18 years (if the legal age of consent is >18 years old, then follow local regulatory 
requirements23). 
3. Has a life expectancy ≥3 months based on Investigator’s opinion. 
4. Has pathologically documented Stage IIIB, IIIC, or Stage IV NSCLC with or without 
actionable genomic alteration(s) (AGA) at the time of randomization (based on the American 
Joint Committee on Cancer, Eighth Edition) and meets the following criteria for NSCLC: 
(Note: Subjects with NSCLC with AGA are eligible from Protocol version 4.0): 
Subjects Without AGA: 
• Subjects must have documented negative test results for EGFR and ALK genomic 
alterations.  If test results for EGFR and ALK are not available, subjects are required 
to undergo testing performed locally for these genomic alterations. 
• Subjects have no known genomic alterations in ROS1, NTRK, BRAF, MET exon 14 
skipping, or RET. 
In Argentina only, please see Section 10.9.2 for modified text applicable to 
Argentina. 
• Subjects with known KRAS mutations (testing during screening is not mandatory), in 
the absence of any driver genomic alterations, are eligible and must meet the prior 
therapy requirements for subjects without actionable genomic alterations described 
below.  These subjects must be stratified as NSCLC without AGA at the time of 
randomization. 
Subjects With AGA: 
• Subjects must have 1 or more documented actionable genomic alteration: EGFR, 
ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.  
In Argentina only, please see Section 10.9.2 for modified text applicable to 
Argentina. 

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5. Subjects must have documentation of radiographic disease progression while on or after 
receiving the most recent treatment regimen for advanced or metastatic NSCLC. 
6. Subject must meet the following prior therapy requirements: 
Subjects without AGA must meet ONE of the following prior therapy requirements for 
advanced or metastatic NSCLC: 
a. Received platinum-based chemotherapy in combination with α-PD-1/α-PD-L1 
monoclonal antibody as the only prior line of therapy. 
− Includes subjects who received prior platinum-based chemotherapy with or without 
radiotherapy with maintenance α-PD-1/α-PD-L1 monoclonal antibody for Stage III 
disease and relapsed/progressed within 6 months from the last dose of platinum-based 
chemotherapy. 
− Includes subjects who received prior platinum-based chemotherapy with or without 
radiotherapy (with or without maintenance α-PD-1/α-PD-L1 monoclonal antibody) for 
Stage III disease and subsequently received α-PD-1/α-PD-L1 monoclonal antibody 
therapy (with or without platinum-based chemotherapy) for recurrent disease. 
OR 
b. Received platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody (in 
either order) sequentially as the only 2 prior lines of therapy. 
NOTE:  
i. 
Subjects who received α-PD-1/α-PD-L1 monoclonal antibody as first-line therapy may 
have received the combination of platinum-based chemotherapy and α-PD1/α-PD-L1 
monoclonal antibody in the second line. 
ii. 
Subjects with known KRAS mutation, in the absence of other AGA, who received 
KRAS-approved target therapy (eg, sotorasib) as a separate line of therapy in addition 
to the prior therapy requirements described above are not eligible. 
Subjects with AGA must meet the following prior therapy requirements for advanced or 
metastatic NSCLC: 
a. Has been treated with 1 or 2 prior lines of applicable targeted therapy that is locally 
approved for the subject’s genomic alteration at the time of screening; OR one or more of 
the agents specified in the table below: 
− Subjects who have tumors with EGFR L858R or exon 19 deletion mutations must 
have received prior Osimertinib. 
− Those who received a targeted agent as adjuvant therapy for early-stage disease must 
have relapsed or progressed while on the treatment or within 6 months of the last dose 
OR received at least one additional course of targeted therapy for the same genomic 
alteration (which may or may not be same agent used in the adjuvant setting) for 
relapsed/progressive disease. 

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− Subjects who have been treated with a prior TKI must receive additional approved 
targeted therapy, if locally available and clinically appropriate, for the applicable 
genomic alteration, or the subject will not be allowed in the study. 
Genomic Alterations 
Applicable Targeted Agents 
EGFR 
erlotinib, gefitinib, afatinib, dacomitinib, and osimertinib 
EGFR exon 20 insertion 
amivantamab, mobocertinib 
EGFR T790M 
osimertinib 
ALK fusion 
crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib 
ROS-1 fusion 
entrectinib, lorlatinib, ceritinib, and crizotinib 
NTRK fusion 
entrectinib and larotrectinib 
BRAF V600E 
dabrafenib, alone or in combination with trametinib 
MET exon 14 skipping 
capmatinib and tepotinib 
RET rearrangement 
selpercatinib and pralsetinib  
ALK = anaplastic lymphoma kinase; BRAF = proto-oncogene B-raf; EGFR = epidermal growth factor receptor; MET 
= mesenchymal-epithelial transition; NTRK = neurotrophic tyrosine receptor kinase; RET = rearranged during 
transfection; ROS-1 = ROS proto-oncogene 1; TKI = tyrosine kinase inhibitor 
b. Has received platinum-based chemotherapy as the only prior line of cytotoxic therapy: 
− One platinum-containing regimen for advanced disease  
− Those who received a platinum-containing regimen as adjuvant therapy for 
early-stage disease must have relapsed or progressed while on the treatment or within 
6 months of the last dose OR received at least one additional course of 
platinum-containing therapy (which may or may not be same as in the adjuvant 
setting) for relapsed/progressive disease. 
c. May have received up to one α-PD-1/α-PD-L1 monoclonal antibody alone or in 
combination with a cytotoxic agent.  
7. Must undergo a pre-treatment tumor biopsy procedure. 
OR 
If available, tumor tissue previously retrieved from a biopsy procedure performed within 
2 years prior to the subject signing informed consent and that has a minimum of 
10 × 4 micron sections or a tissue block equivalent of 10 × 4 micron sections may be 
substituted for the pre-treatment biopsy procedure during Screening.  If a documented law or 
regulation prohibits (or does not approve) sample collection, then such samples will not be 
collected/submitted. 
Note: Results from the TROP2 testing of the pre-treatment tumor biopsy will not be used to 
determine eligibility for the study. 
8. Inclusion Criterion removed. 
9. Has measurable disease based on local imaging assessment using RECIST v1.1. 
10. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at 
Screening. 
11. Within 7 days before randomization, has adequate bone marrow function defined as: 

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• Platelet count ≥100,000/mm3 (platelet transfusion is not allowed within 1 week prior 
to Screening assessment) 
• Hemoglobin ≥9.0 g/dL (red blood cell/plasma transfusion is not allowed within 
1 week prior to Screening assessment) 
• Absolute neutrophil count ≥1500/mm3 (granulocyte-colony stimulating factor 
[G-CSF] administration is not allowed within 1 week prior to Screening assessment) 
− (See Section 6.5.2 and Section 6.6 for use of G-CSF and erythropoietin) 
12. Within 7 days before randomization, has adequate hepatic function defined as:  
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper 
limit of normal (ULN) or AST and ALT ≤5.0 × ULN if transferase elevation is due to 
liver metastases AND 
• Total bilirubin ≤1.5 × ULN (or <3.0 × ULN in the presence of documented Gilbert’s 
syndrome [unconjugated hyperbilirubinemia] or liver metastases at baseline).  
Note: The Investigator should follow local practice guidelines and/or the docetaxel 
label approved in the country of drug administration for assessing eligibility of 
subjects for the study. 
13. Within 7 days before randomization, has adequate renal function, including mild or moderate 
renal function, defined as: 
• Creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation 
14. Has left ventricular ejection fraction (LVEF) ≥50% by either ECHO or MUGA scan within 
28 days before randomization.  
15. Has adequate blood clotting function defined as international normalized ratio/prothrombin 
time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × ULN. 
16. Has an adequate treatment washout period before randomization, defined as:  
Treatment 
Washout Period 
Major surgery 
≥3 weeks 
Radiation therapy including 
palliative radiation to chest 
≥4 weeks  
≥2 weeks (palliative radiation therapy to 
other areas [ie, limited field and 10 or 
fewer days or fractions] including whole 
brain radiotherapy) 
Anticancer chemotherapy 
(Immunotherapy 
[non-antibody-based therapy]), 
retinoid therapy 
≥2 weeks or 5 times the t1/2 of the 
chemotherapeutic agent, whichever is 
longer; ≥6 weeks for nitrosoureas or 
mitomycin C; ≥1 week for tyrosine 
kinase inhibitors approved for the 
treatment of NSCLC-baseline computed 
tomography (CT) scan should be 
completed after discontinuation of 
tyrosine kinase inhibitors. 

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Treatment 
Washout Period 
Antibody-based anticancer 
therapy 
≥4 weeks 
Chloroquine/Hydroxychloroquine >14 days 
In Czech Republic only, please see Section 10.9.1 for modified text applicable to sites in 
Czech Republic. 
17. If the subject is a female of childbearing potential, she must have a negative serum pregnancy 
test at Screening and must be willing to use highly effective birth control (as detailed in 
Section 10.3.4) upon enrollment, during the Treatment Period, and for at least 7 months, after 
the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel.  
Non-childbearing potential is defined as pre-menopausal females with a documented tubal 
ligation or hysterectomy; or post-menopausal defined as 12 months of spontaneous 
amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating 
hormone >40 mIU/mL and estradiol <40 pg/mL [<147 pmol/L] is confirmatory).  Females on 
hormone replacement therapy (HRT) and whose menopausal status is in doubt will be 
required to use one of the contraception methods outlined for women of childbearing 
potential if they wish to continue their HRT during the study.  Otherwise, they must 
discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.  
For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy 
and the blood draw; this interval depends on the type and dosage of HRT.  Following 
confirmation of their post-menopausal status, they can resume use of HRT during the study 
without use of a contraceptive method.  
18. If male, the subject must be surgically sterile or must use a condom in addition to highly 
effective birth control if his partners are of reproductive potential upon enrollment, during the 
Treatment Period, and for at least 4 months after the last dose of DS-1062a or for at least 
6 months after the last dose of docetaxel. 
19. Male subjects must not freeze or donate sperm starting at Screening and throughout the study 
period, and for at least 4 months after the last dose of DS-1062a or for at least 6 months after 
the last dose of docetaxel.  Preservation of sperm should be considered before enrollment in 
the study.  
20. Female subjects must not donate, or retrieve for their own use, ova from the time of 
Screening and throughout the study treatment period, and for at least 7 months after the last 
dose of DS-1062a or for at least 6 months after the last dose of docetaxel.  Preservation of 
ova should be considered prior to enrollment in the study. 
21. Be willing and able to comply with scheduled visits, drug administration plan, laboratory 
tests, other study procedures, and study restrictions. 
5.2. 
Exclusion Criteria 
Subjects who meet any of the following criteria will be disqualified from entering the study: 
1. Has mixed small-cell lung cancer (SCLC) and NSCLC histology. 

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2. Has spinal cord compression or clinically active central nervous system (CNS) metastases, 
defined as untreated and symptomatic, or requiring therapy with corticosteroids or 
anticonvulsants to control associated symptoms.  Subjects with clinically inactive brain 
metastases may be included in the study.  Subjects with treated brain metastases who are no 
longer symptomatic and who require no treatment with corticosteroids or anticonvulsants 
may be included in the study if they have recovered from the acute toxic effect of 
radiotherapy.  A minimum of 2 weeks must have elapsed between the end of whole brain 
radiotherapy and study enrollment.  Note: A CT or magnetic resonance imaging (MRI) scan 
of the brain at baseline is required for all subjects.  For those subjects in whom CNS 
metastases are first discovered at the time of Screening, the treating Investigator should 
consider delay of study treatment to document stability of CNS metastases with repeat 
imaging at least 4 weeks later (in which case, repeat of all Screening activity may be 
required). 
3. Has leptomeningeal carcinomatosis or metastasis.  
4. Had prior treatment with:  
a. Any agent, including an ADC, containing a chemotherapeutic agent targeting 
topoisomerase I. 
b. TROP2-targeted therapy. 
c. Docetaxel.  
5. Had prior treatment with platinum-based chemotherapy and prior immunotherapy for Stage 
II NSCLC disease (eg, in the neo-adjuvant or adjuvant setting) without subsequently meeting 
the prior therapy requirements for Stage III or metastatic NSCLC disease as described in 
Inclusion Criterion 6. 
6. Has NSCLC disease that is eligible for definitive local therapy alone. 
7. Uncontrolled or significant cardiac disease, including: 
a. Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) prolongation 
>470 msec (based on the average of Screening triplicate 12-lead ECG determinations). 
b. Myocardial infarction or uncontrolled/unstable angina within 6 months before 
randomization. 
c. Congestive heart failure (CHF) (New York Heart Association Class II to IV) at 
Screening.  Subjects with a history of Class II to IV CHF prior to Screening, must have 
returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA scan 
within 28 days before randomization) in order to be eligible (see criteria in 
Section 10.3.2). 
d. Uncontrolled or significant cardiac arrhythmia. 
e. LVEF <50% by ECHO or MUGA scan within 28 days before randomization. 
f. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic 
blood pressure >110 mmHg) within 28 days before randomization. 
8. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current 
ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at 
Screening. 

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9. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses 
including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli 
within 3 months before randomization, severe asthma, severe chronic obstructive pulmonary 
disease, restrictive lung disease, pleural effusion, etc.), or any autoimmune, connective tissue 
or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren’s 
syndrome, sarcoidosis, etc.), or prior pneumonectomy. 
10. Has significant third-space fluid retention (for example ascites or pleural effusion) and is not 
amenable for required repeated drainage. 
11. Clinically significant corneal disease. 
12. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected 
infections (eg, prodromal symptoms); or inability to rule out infections.  Note: Subjects with 
localized fungal infections of skin or nails are eligible. 
13. Has known human immunodeficiency virus (HIV) infection that is not well controlled. All 
the following criteria are required to define an HIV infection that is well controlled: 
undetectable viral RNA load, CD4+ counts/levels >250, no history of AIDS-defining 
opportunistic infection within the past 12 months, and stable for at least 4 weeks on same 
anti-HIV retroviral medications.  If an HIV infection meets the above criteria, the subject’s 
viral RNA load and CD4+ cell count should be monitored per local standard of care (eg, 
every 3 months).  Subjects should be tested for HIV prior to randomization if required by 
local regulations or Institutional Review Board (IRB)/Ethics Committee (EC). 
14. Has an active or uncontrolled hepatitis B and/or hepatitis C infection, is positive for hepatitis 
B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis B surface 
antigen [HBsAg], anti-hepatitis B surface antibody [anti-HBs], anti-hepatitis B core antibody 
[anti-HBc], or hepatitis B virus [HBV] DNA), and/or hepatitis C infection (as per hepatitis C 
virus [HCV] RNA) within 28 days of randomization.  
Subjects are eligible if:  
a. Subjects have received hepatitis B vaccination with only anti-HBs positivity and no 
clinical signs of hepatitis. 
b. Subjects who are HbsAg+ with HBV infection for more than 6 months (ie, chronic 
HBV infection) must meet the following conditions: 
i. 
HBV DNA viral load <2000 IU/mL. 
ii. 
Have normal transaminase values, or, if liver metastases are present, abnormal 
transaminases with a result of AST/ALT <3 × ULN that are not attributable to 
HBV infection.  
iii. 
Start or maintain antiviral treatment if clinically indicated as per the 
Investigator.  
c. Subjects have been curatively treated for hepatitis C infection as demonstrated 
clinically and by viral serology.  
15. Has a history of malignancy, other than NSCLC except a) adequately resected 
non-melanoma skin cancer, b) curatively treated in situ disease, or c) other solid tumors 
curatively treated, with no evidence of disease for ≥3 years. 

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16. Concomitant medical condition that would increase the risk of toxicity in the opinion of 
the Investigator. 
17. Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) 
not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline.  Note: Subjects may 
be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to >Grade 2 
for at least 3 months prior to randomization and managed with standard of care treatment) 
which the Investigator deems related to previous anticancer therapy, comprised of 
(including but not limited to):   
a. Chemotherapy-induced neuropathy 
b. Fatigue 
c. Residual toxicities from prior immunotherapy treatment: Grade 1 or Grade 2 
endocrinopathies which may include: 
− Hypothyroidism/ hyperthyroidism 
− Type I diabetes 
− Hyperglycemia 
− Adrenal insufficiency 
− Adrenalitis 
d. Skin hypopigmentation (vitiligo) 
18. Has a history of severe hypersensitivity reactions to either the drug substances or inactive 
ingredients (including but not limited to polysorbate 80) of DS-1062a or docetaxel. 
19. History of severe hypersensitivity reactions to other monoclonal antibodies.  
20. Is pregnant or breastfeeding or planning to become pregnant. 
21. Has substance abuse or any other medical conditions such as clinically significant cardiac 
or psychological conditions, that may, in the opinion of the Investigator, interfere with 
the subject’s participation in the clinical study or evaluation of the clinical study results. 
22. Psychological, social, familial, or geographical factors that would prevent regular follow 
up.  Adults under guardianship, curatorship, safeguard of justice, or family empowerment 
measure are not eligible. 
23. Otherwise considered inappropriate for the study by the Investigator. 
5.3. 
Screening Failures, Rescreening, and Subject Replacement 
For subjects who do not meet the criteria for participation in the study (screen failures), the 
reason for screen failure must be recorded in the Screening Log.   
Subjects who have dropped out of the study will not be replaced. 
Rescreening is permitted 1 time for any subject.  The Rescreening Period for subjects who are 
rescreened is also 28 days.  A new subject identification number must be provided at the time of 
rescreening.   

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6. 
STUDY TREATMENT 
See Figure 1.1 for treatment sequence. 
6.1. 
Study Drug Description 
6.1.1. 
DS-1062a 
Table 6.1 describes the formulation, dose, regimen, duration, packaging, and labeling of 
DS-1062a. 
Table 6.1: 
DS-1062a Dosing Information 
Study Drug Name 
DS-1062a (Datopotamab Deruxtecan; Dato-DXd) 
Dosage Formulation 
DS-1062a DP will be provided 
 
 
 
  
Dosage Levels 
6.0 mg/kg 
Route of Administration 
IV infusion 
Dosing Instructions/Regimen 
One IV infusion every 3 weeks on Day 1 of each 21-day cycle.  
Premedication is required prior to any dose of DS-1062a and must 
include antihistamines and acetaminophen, with or without 
glucocorticoids.  Subjects should remain at the site for at least 1-hour 
post infusion of DS-1062a for close observation for possible allergic 
reaction. 
If a subject doesn’t experience any IRR during or after the first 2 cycles, 
the post-infusion observation period can be shortened to at least 30 
minutes for subsequent cycles. Subjects with identified IRR related to the 
study drug should be observed post-infusion for at least 1 hour for the 2 
cycles after the IRR event and for at least 30 minutes at each subsequent 
cycle.  
Duration 
The initial dose will be infused over approximately 90 minutes on 
Cycle 1 Day 1.  In the absence of an IRR, the subsequent doses will be 
infused over approximately 30 minutes.  In case of IRR at any time 
during treatment, all subsequent doses will be infused over 90 minutes.  
Additional details are provided in Table 6.4. 
Packaging 
DS-1062a will be supplied by the Sponsor.  The packaging will be 
clearly labeled “For Clinical Study Trial Only,” and will show the 
display name of the study drug, the lot number, storage condition, 
protocol number and other required information in accordance with local 
regulations. 
Labeling 
DS-1062a glass vials will be labeled as required per local regulatory 
requirement. 
DP = drug product; h = hour; IRR = infusion-related reaction; IV = intravenous; 
 
 min = minute 
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6.1.2. 
Docetaxel 
Table 6.2 describes the formulation, dose, regimen, duration, packaging, and labeling of 
docetaxel. 
Table 6.2: 
Docetaxel Dosing Information 
Study Drug Name 
Docetaxel 
Dosage Formulation 
Docetaxel will be provided as an injection vial consisting of 80 mg/4 ml 
in a single-use vial, to be used in an infusion bag or bottle of either 0.9% 
Sodium Chloride solution or 5% Dextrose solution 
Dosage Levels 
75 mg/m2 
Route of Administration 
IV infusion 
Dosing Instructions/Regimen 
One IV infusion on Day 1 of each 3-week cycle.  Subjects should be 
premedicated with oral corticosteroids, such as dexamethasone 16.0 mg 
per day (for example, 8.0 mg twice a day) for 3 days starting 1 day prior 
to docetaxel administration, in order to reduce the incidence and severity 
of fluid retention as well as the severity of hypersensitivity reactions.  
Additional antiemetic premedication may be used at the discretion of the 
Investigator. 
Duration 
Docetaxel will be infused over approximately 60 minutes on Day 1 of 
each 3-week cycle.  Investigators should consult the locally approved 
manufacturer’s instructions for docetaxel for complete prescribing 
information (including warnings, precautions, contraindications, and 
adverse reactions) and follow institutional procedures for the 
administration of docetaxel.19  For instructions for storage and docetaxel 
infusion preparation, consult the study Pharmacy Manual. 
Packaging 
Docetaxel will be supplied by the Sponsor but can be supplied by the 
study site if required such as in case of Sponsor supply disruption or 
local regulatory requirements.  The packaging will be clearly labeled 
“For Clinical Trial Use Only,” and will show the display name of the 
study drug, the lot number, storage condition, protocol number and other 
required information in accordance with local regulations. 
Labeling 
Docetaxel glass vials will be labeled as required per local regulatory 
requirement. 
DP = drug product; h = hour; IRR = infusion-related reaction; IV = intravenous; 
 
 min = minute 
6.2. 
Preparation, Handling, Storage, and Accountability for Study Drug 
6.2.1. 
DS-1062a 
Preparation, Handling, and Disposal 
The preparation of study drug will be conducted in accordance with the Pharmacy Manual 
provided by the Sponsor.  The drug for IV infusion is prepared by dilution of the required 
volume of the DP calculated based on the subject’s baseline body weight, defined as the last 
measurement on or before the first dose.  Prepared medicinal solutions should be used 
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immediately.  Refer to the Pharmacy Manual for detailed information about preparation and 
administration of DS-1062a. 
Procedures for proper handling and disposal should be followed in compliance with the standard 
operating procedures or other institutional guidelines of the site. 
Administration 
DS-1062a will be administered as a 6.0 mg/kg IV infusion Q3W on Day 1 of each 21-day cycle.  
Premedication is required prior to any dose of DS-1062a and must include antihistamines and 
acetaminophen, with or without glucocorticoids. All premedication administered must be 
adequately documented in the electronic Case Report Form (eCRF). 
For prevention of oral mucositis/stomatitis, subjects are advised to initiate a daily oral care 
protocol (OCP) before study intervention initiation and maintain it throughout the study.  An 
OCP should include daily inert, bland mouth rinses (eg, with a nonalcoholic, 
bicarbonate-containing mouthwash 4 to 6 times a day), although other prophylaxis regimens (eg, 
dexamethasone oral solution 0.1 mg/mL 10 mL 3 to 4 times daily swish for 1 minute to 
2 minutes then spit out, as well as cryotherapy throughout the infusion) advocated by 
institutional/local guidelines are permitted.  An OCP should also include educating subjects on 
the importance of oral hygiene, tooth brushing, flossing, and hydration and lubrication of the oral 
mucosa, and on the benefits of adhering to their recommended OCP.  Per Investigator judgment, 
a professional dental evaluation before study drug initiation and dental treatment, if indicated, 
may reduce the risk of local and systemic infections from odontogenic sources. 
The initial dose of DS-1062a will be infused over approximately 90 minutes.  If there is no IRR, 
after the initial dose, the next dose of DS-1062a will be infused over approximately 30 minutes.  
In case of IRR at any time during treatment, all subsequent doses will be infused over 
90 minutes.  Additional details are provided in Table 6.4.  Subjects should remain at the site for 
at least 1-hour post infusion of DS-1062a for close observation for possible allergic reaction. If a 
subject doesn’t experience any IRR during or after the first 2 cycles, the post-infusion 
observation period can be shortened to at least 30 minutes for subsequent cycles. Subjects with 
identified IRR related to the study drug should be observed post-infusion for at least 1 hour for 
the 2 cycles after the IRR event and for at least 30 minutes at each subsequent cycle.  
The subject’s weight at screening will be used as the baseline weight to calculate the initial dose 
of DS-1062a, see Table 1.1.  If during the course of treatment, the subject’s weight changes by 
±10% of the baseline weight, the subject’s dose must be recalculated based on the subject’s 
updated weight.  After the recalculation, the updated subject’s weight and body surface area 
(BSA) will be used as the new baseline weight.  The site may follow local institutional policy for 
re-calculating dose based on weight changes less than 10%. 
 
Storage 
Drug supplies must be stored in a secure, limited access storage area under the recommended 
storage conditions as noted on the label: 
 
   
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If storage conditions are not maintained per specified requirements, then the Sponsor or contract 
research organization (CRO) should be contacted.  See the Pharmacy Manual for additional 
information on storage conditions of study drug and storage conditions of the infusion solution. 
Drug Accountability 
When a drug shipment is received, the pharmacist or designee will check the amount and 
condition of the drug against the shipping documentation.  The pharmacist or designee shall 
contact the Sponsor as soon as possible if there is a problem with the shipment. 
The Receipt of Shipment Form should be faxed as instructed on the form unless receipt is 
controlled by Interactive Response Technology (IRT).  The original will be retained at the study 
site.   
The pharmacist is responsible for study drug accountability, reconciliation and record 
maintenance (ie, Receipt of Shipment Form, dispensation/return record, and certificate of 
destruction/return receipt). 
At the end of the study, all unused DS-1062a will be returned or destroyed as per local laws or 
site policy and only after the CRO monitor has completed a final inventory.  As applicable, the 
study site must file a copy of the appropriate institution policy within their Investigator site file 
and provide a copy to the Sponsor.  Please see the Pharmacy Manual for details. 
6.2.2. 
Docetaxel 
Docetaxel is a commercially available product and will be supplied by the study Sponsor.  
Administration 
Docetaxel will be administered as an IV infusion of 75 mg/m2 over approximately 60 minutes on 
Day 1 of each 3-week cycle.  Subjects should be premedicated with oral corticosteroids, such as 
dexamethasone 16.0 mg per day (for example, 8.0 mg twice a day) for 3 days starting 1 day prior 
to docetaxel administration, in order to reduce the incidence and severity of fluid retention as 
well as the severity of hypersensitivity reactions.  Additional antiemetic premedication may be 
used at the discretion of the Investigator. All premedication administered must be adequately 
documented in the eCRF. 
The subject’s BSA must be recalculated, and the docetaxel dose adapted accordingly before each 
subsequent cycle.  Applied dosages should be no more than 10% above or below calculated ones. 
Investigators should consult the locally approved manufacturer’s instructions for docetaxel for 
complete prescribing information (including warnings, precautions, contraindications, and 
adverse reactions) and follow institutional procedures for the administration of docetaxel.19  For 
instructions for storage and docetaxel infusion preparation, consult the study Pharmacy Manual. 
Storage 
Docetaxel supplies must be stored in a secure, limited-access storage area under the 
recommended storage conditions as noted on the label. Do not store above 25 °C. Store in the 
original package in order to protect from light. Do not freeze. 

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If storage conditions are not maintained per specified requirements, then the Sponsor or CRO 
should be contacted.  See the Pharmacy Manual for additional information on storage conditions 
of docetaxel and storage conditions of the prepared infusion solution. 
Drug Accountability 
When a drug shipment is received, the pharmacist or designee will check the amount and 
condition of the drug against the shipping documentation.  The pharmacist or designee shall 
contact the Sponsor as soon as possible if there is a problem with the shipment. 
The Receipt of Shipment Form should be faxed as instructed on the form unless receipt is 
controlled by IRT.  The original will be retained at the study site.   
The pharmacist is responsible for study drug accountability, reconciliation, and record 
maintenance (ie, Receipt of Shipment Form, dispensation/return record, and certificate of 
destruction/return receipt). 
At the end of the study, all unused docetaxel will be returned or destroyed as per local laws or 
site policy and only after the CRO monitor has completed a final inventory.  As applicable, the 
study site must file a copy of the appropriate institution policy within their Investigator site file 
and provide a copy to the Sponsor.  Please see the Pharmacy Manual for details. 
6.3. 
Measure to Minimize Bias: Randomization and Blinding 
Method of Treatment Allocation 
Eligible subjects will be randomized in a 1:1 ratio to DS-1062a 6.0 mg/kg or the control 
treatment, docetaxel.  Randomization will be stratified by documented actionable genomic 
alteration (present versus absent), histology (squamous versus nonsquamous), most immediate 
prior therapy included anti-PD-1/anti-PD-L1 immunotherapy (yes versus no) and geographical 
region (US/Japan/Western Europe versus ROW). 
Randomization will be managed through an IRT for subjects meeting all eligibility criteria.  The 
system will assign a unique randomization number and dose group for that subject.  The 
instructions on how to use the system will be provided in the IRT Manual.   
This is an open-label study. No crossover between study treatment arms will be allowed. 
6.4. 
Treatment Compliance 
DS-1062a or docetaxel will be administered as an IV infusion to subjects under the supervision 
of study site personnel.  Therefore, treatment compliance will be guaranteed as long as the 
subject attends each visit for administration of study drug.  Start and stop date/time of infusion 
must be recorded in the eCRF. 
6.5. 
Guidelines for Dose Modification 
All dose modifications (ie, infusion interruptions, dose delays, re-initiation, dose reduction, 
and/or treatment discontinuation) should be based on the worst preceding toxicity NCI-CTCAE 
v5.0.  Possible exceptions to the dose modification criteria may be allowed on a case-by-case 

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basis after discussion and agreement between the Investigator and Sponsor.  The agreement must 
be documented.  Dose modification decisions may be based on local laboratory results. 
All infusion interruptions, dose delays, or other dose modifications must be recorded in the 
eCRF.  If study drug is delayed, missed doses will not be made up.   
In the event of an infusion interruption or a dose delay occurring prior to completion of a 
PK/pharmacodynamic blood sampling in the study, Investigators should contact the Sponsor 
medical monitor for guidance regarding scheduling of these procedures. 
6.5.1. 
DS-1062a 
Dose Modification Guidelines 
Depending on the severity of the TEAE, the dose of DS-1062a may be delayed for up to 9 weeks 
(63 days) from the planned date of the next cycle administration (ie, up to 12 weeks or 84 days 
from last infusion).  If a subject is assessed as requiring a dose delay longer than 12 weeks or 84 
days from last infusion, the subject must discontinue treatment with DS-1062a. Study treatment 
dose delay for conditions other than toxicity resolution should be kept as short as possible.  
If a subject cannot restart study treatment for other reasons, eg, intercurrent conditions not 
related to disease progression or toxicity, the case should be discussed with the Daiichi Sankyo 
study physician. 
Up to 3 dose reductions will be permitted for subjects receiving DS-1062a (Table 6.3).  Once the 
dose of DS-1062a is reduced, no dose re-escalation will be permitted.  After the permitted dose 
reductions, if further toxicity meeting the requirement for dose reduction occurs, the subject will 
be withdrawn from the study treatment.   
Table 6.3: 
Dose Reduction Levels for DS-1062a 
Starting Dose 
Dose Reduction 1 
Dose Reduction 2 
Dose Reduction 3 
6.0 mg/kg 
4.0 mg/kg 
3.0 mg/kg 
2.0 mg/kg 
Infusion Interruptions, Dose Delays, and Other Dose Modifications – Toxicity Management 
Guidelines 
Dose modification criteria for subjects with suspected or confirmed COVID-19, also known as 
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), are presented in Section 10.7. 
Specific criteria for DS-1062a infusion interruptions, dose delays, re-initiation, dose reduction, 
and/or discontinuation in case of TEAEs that are considered related to the use of DS-1062a by 
the Investigator are presented in Table 6.4, which is applicable only to TEAEs that are assessed 
as related to use of DS-1062a by the Investigators.  For non-drug-related TEAEs or if nothing is 
noted in Table 6.4, standard clinical practice should be followed.  Appropriate experts should be 
consulted as deemed necessary.  The Investigator may consider infusion interruptions, dose 
delays, or DS-1062a discontinuation based on other events not listed in Table 6.4 according to 
the subject’s condition.  
There will be no dose modifications for Grade 1 or Grade 2 TEAEs unless specified in Table 6.4.  
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should be performed frequently and at an interval no greater than 7 days.  The dose may be 
delayed for up to 9 weeks (63 days) from the planned date of the next cycle administration (ie, 
up to 12 weeks or 84 days from the last infusion).  If a subject is assessed as requiring a dose 
delay longer than 12 weeks or 84 days from the last infusion, the subject must discontinue 
treatment with DS-1062a. 
Treatment cycles for a subject for whom DS-1062a dosing is temporarily withheld for any reason 
may have future cycles scheduled based on the date of the last DS-1062a dose. 

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Table 6.4: 
Dose Modifications for Non-hematologic and Hematologic Toxicity Related 
to DS-1062a 
Worst Toxicity 
NCI-CTCAE v5.0 Grade  
(unless otherwise 
specified) 
Management Guidelines for DS-1062a 
Infusion-Related Reaction  
Premedication is required prior to any dose of DS-1062a and must include antihistamines and 
acetaminophen with or without glucocorticoids.  Subjects should remain at the site for at least 1-hour 
post infusion of DS-1062a for close observation for possible allergic reaction. 
If a subject doesn’t experience any IRR during or after the first 2 cycles, the post-infusion observation 
period can be shortened to at least 30 minutes for subsequent cycles. Subjects with identified IRR 
related to the study drug should be observed post-infusion for at least 1 hour for the 2 cycles after the 
IRR event and for at least 30 minutes at each subsequent cycle.  
Grade 1 
If any signs or symptoms of infusion-related reaction (such as fever and 
chills, with and without nausea/vomiting, pain, headache, dizziness, 
dyspnea, Grade 1 or 2 hypotension) is observed during administration, the 
infusion rate should be reduced by 50% of the initial infusion rate and 
subjects should be closely monitored.  
If no other reactions appear upon resumption of the study drug at the 
above reduced infusion rate, then the infusion rate for subsequent 
treatment cycles may be resumed at the initial infusion rate. 
Grade 2  
Administration of DS-1062a should be interrupted briefly.  Symptomatic 
treatment should be started. 
• 
If the event resolves or improves to Grade 1, infusion can be 
restarted at a 50% reduced infusion rate (ie, 180 minutes for a 90-
minute infusion and 60 minutes for a 30-minute infusion). 
• 
If an IRR recurs upon rechallenge of DS-1062a while it is being 
infused at a reduced rate during the same cycle, then treat as 
Grade 3 and follow the Grade 3 TMG. 
If there is no recurrence, the subsequent infusion should be 
administered at a reduced rate. 
• 
If there is no new IRR, then DS-1062a can be administered at the 
initial planned infusion rate (90 or 30 minutes) for subsequent 
treatment cycles. 

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Worst Toxicity 
NCI-CTCAE v5.0 Grade  
(unless otherwise 
specified) 
Management Guidelines for DS-1062a 
Grade 3  
Administration of DS-1062a should be stopped immediately for that 
cycle and initiate treatment of the IRR symptoms. 
• 
If the IRR does not resolve within the same day, recurrence of 
symptoms occurs following initial improvement, or hospitalization 
is necessary for clinical sequelae, then permanently discontinue 
DS-1062a. 
• 
If the IRR resolves within the same day of DS-1062a infusion, no 
recurrence of symptoms occurs following initial improvement, and 
no hospitalization is necessary for clinical sequelae, then for the 
next cycle, administer DS-1062a at a 50% reduced infusion rate (ie, 
180 minutes for a 90-minute infusion; 60 minutes for a 30-minute 
infusion). 
o If there is no new IRR, then for the subsequent cycle, 
administer DS-1062a at the initial infusion rate (90 or 30 
minutes).  If the subject tolerates that initial infusion rate with 
no new IRR, then for the subsequent cycles, administer DS-
1062a at the same infusion rate (90 or 30 minutes). 
• 
If a new IRR occurs that is Grade 2 or greater with subsequent 
cycles, permanently discontinue DS-1062a and initiate treatment of 
the IRR symptoms. 
Grade 4 
Administration of DS-1062a must be discontinued immediately and 
permanently.  
Urgent intervention is indicated. Epinephrine, antihistamines, steroids, 
bronchodilators, vasopressors, IV fluid therapy, supplemental oxygen, 
etc. should be considered as clinically indicated.   
Hematologic Toxicity 
Neutrophil Count Decreased and/or White Blood Cell Count Decreased 
Grade 3 (ANC defined as 
<1.0-0.5 × 109/L; WBC 
defined as <2.0-1.0 
×109/L) 
Delay dose until resolved to ≤Grade 2, then maintain dose. 
Grade 4 (ANC defined as 
<0.5-0.5 ×109/L; WBC 
defined as <1.0 × 109/L) 
Delay dose until resolved to ≤Grade 2: 
• 
If resolved in ≤14 days from day of onset, maintain dose. 
• 
If resolved in >14 days from day of onset, reduce dose by 1 level. 
Febrile Neutropenia  
Grade 3 
Delay dose until resolved, then reduce dose by 1 level. 
Grade 4 
Discontinue subject from study treatment. 

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Worst Toxicity 
NCI-CTCAE v5.0 Grade  
(unless otherwise 
specified) 
Management Guidelines for DS-1062a 
Lymphocyte Count Decreased 
Grade 4  
Delay dose until resolved to ≤Grade 2: 
• 
If resolved in ≤14 days from day of onset, maintain dose. 
• 
If resolved in >14 days from day of onset, reduce dose by 1 level. 
Anaemia 
Grade 3  
Delay dose until resolved to ≤Grade 2, then maintain dose. 
Grade 4  
Delay dose until resolved to ≤Grade 2, then reduce dose by 1 level. 
Platelet Count Decreased 
Grade 3  
Delay dose until resolved to ≤Grade 1: 
• 
If resolved in ≤7 days from day of onset, maintain dose. 
If resolved in >7 days from day of onset, reduce dose by 1 level. 
Grade 4  
• 
Delay dose until resolved to ≤Grade 1, then reduce dose by 1 level. 
Non-hematologic Toxicities 
Pulmonary Toxicity 
If a subject develops radiographic changes potentially consistent with ILD/pneumonitis or develops an 
acute onset of new or worsening pulmonary or other related signs/symptoms such as dyspnea, cough or 
fever, rule out ILD/pneumonitis.  
If the AE is confirmed to have an etiology other than treatment-related ILD/pneumonitis, follow the 
management guidance outlined in the “Other Non-laboratory Adverse Events” dose modification 
section below. 
If the AE is suspected to be ILD/pneumonitis, treatment with DS-1062a should be delayed pending 
further evaluations.  
Evaluations should include: 
• 
High-resolution CT  
• 
Pulmonologist consultation (infectious disease consultation, as clinically indicated) 
• 
Bronchoscopy and BAL if clinically indicated and feasible 
• 
Pulmonary function tests (including FVC and CO diffusing capacity) and pulse oximetry 
(SpO2)  
• 
Clinical laboratory tests (arterial blood gases if clinically indicated, blood culture, blood cell 
count, differential white blood cell count, C-reactive protein, and a COVID-19 test). 
• 
One blood sample collection for PK analysis as soon as ILD/pneumonitis is suspected, if 
feasible 
 
If the AE is confirmed to be ILD/pneumonitis as per the above evaluations, follow the 
ILD/pneumonitis management guidance as outlined below. 

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Worst Toxicity 
NCI-CTCAE v5.0 Grade  
(unless otherwise 
specified) 
Management Guidelines for DS-1062a 
All events of ILD/pneumonitis regardless of severity or seriousness must be followed until resolution 
including after DS-1062a discontinuation. 
Grade 1 
The administration of DS-1062a must be delayed for any 
ILD/pneumonitis events regardless of grade.  
• 
Monitor and closely follow up in 2 to 7 days for onset of clinical 
symptoms and pulse oximetry (SpO2). 
• 
Consider follow-up imaging in 1 to 2 weeks (or as clinically 
indicated). 
• 
Consider starting systemic steroids (eg, at least 0.5 mg/kg/day 
prednisone or equivalent) until improvement, followed by gradual 
taper over at least 4 weeks. 
• 
If event worsens despite initiation of corticosteroids, then follow 
Grade 2 guidelines.a 
For Grade 1 events, DS-1062a can be restarted only if the event is fully 
resolved to Grade 0: b 
• 
If resolved in ≤28 days from day of onset, maintain dose 
• 
If resolved in >28 days from day of onset, reduce dose by 1 level  
However, if the Grade 1 ILD/pneumonitis has not resolved within 
84 days from the last infusion, the drug should be permanently 
discontinued. 
a. If subject is asymptomatic but is given steroid treatment, then event 
should be considered as Grade 1. 
b. Grade 0 refers to full resolution of ILD/pneumonitis, including the 
disappearance of radiological findings associated with active 
ILD/pneumonitis. Residual scarring or fibrosis following recovery of 
ILD/pneumonitis is not considered to be active disease. 

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Worst Toxicity 
NCI-CTCAE v5.0 Grade  
(unless otherwise 
specified) 
Management Guidelines for DS-1062a 
Grade 2 
Permanently discontinue subject from study treatment. 
• 
Promptly start and treat with systemic steroids (eg, at least 1 
mg/kg/day prednisone or equivalent) for at least 14 days or until 
complete resolution of clinical and chest CT findings, then followed 
by gradual taper over at least 4 weeks. 
• 
Monitor symptoms closely. 
• 
Re-image as clinically indicated. 
• 
If worsening or no improvement in clinical or diagnostic observations 
in 5 days,  
o Consider increasing dose of steroids (eg, 2 mg/kg/day 
prednisone or equivalent) and administration may be switched to 
intravenous (eg, methylprednisolone). 
o Re-consider additional workup for alternative etiologies as 
described previously. 
o Escalate care as clinically indicated. 
Grade 3 and 4 
Permanently discontinue subject from study treatment. 
• 
Hospitalization is required. 
• 
Promptly initiate empiric high-dose methylprednisolone IV treatment 
(eg, 500 to 1000 mg/day for 3 days), followed by at least 1 mg/kg/day 
of prednisone (or equivalent) for at least 14 days or until complete 
resolution of clinical and chest CT findings, then followed by gradual 
taper over at least 4 weeks. 
• 
Re-image as clinically indicated. 
• 
If still no improvement within 3 to 5 days,  
o Re-consider additional workup for alternative etiologies as 
described above. 
o Consider other immuno-suppressants and/or treat per local 
practice. 

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Worst Toxicity 
NCI-CTCAE v5.0 Grade  
(unless otherwise 
specified) 
Management Guidelines for DS-1062a 
Ocular Surface Toxicity 
(eg, dry eye, decreased or blurred vision, photophobia, keratitis, corneal ulcer) 
General considerations 
Consider obtaining an ophthalmological assessment to ensure accurate 
diagnosis, event grading, appropriate treatment, and event resolution, as 
appropriate.  
It should be strongly recommended that subjects avoid the use of contact 
lenses starting on the day of the first DS-1062a dose and to use artificial 
tears (preferably preservative-free) 4 times per day as preventative 
measure and up to 8 times per day as clinically needed. 
Use of eye medications (eg, topical corticosteroids) other than artificial 
tears should be at the discretion of an ophthalmologist or if unavailable, 
another licensed eye care provider.  
The following grading scale replaces the CTCAE 5.0 grades for 
triggering the toxicity management guidelines for cornea-related AEs: 
Corneal Toxicity Severity Grading Scale 
Normal = Clear cornea, no epithelial defects 
Grade 1 = Nonconfluent superficial keratitis 
Grade 2 = Confluent superficial keratitis, a cornea defect, or 3-line or 
more loss in best corrected distance visual acuity 
Grade 3 = Corneal ulcer or stromal opacity, or best corrected distance 
visual acuity 20/200 or worse 
Grade 4 = Corneal perforation 
Grade 1 
Consider obtaining an ophthalmological assessment.  
Grade 2 
Obtain an ophthalmological assessment. Delay dose until resolved to ≤ 
Grade 1, then maintain dose.  
Grade 3 
Obtain an ophthalmological assessment. Delay dose until resolved to ≤ 
Grade 1, then reduce dose by 1 level. 
Grade 4 
Obtain an urgent ophthalmological assessment. Discontinue subject from 
study treatment.  
Hepatic Toxicity 
AST or ALT with Simultaneous Total Bilirubin Increased 
AST/ALT ≥3.0 × ULN 
with simultaneous total 
bilirubin >2.0 × ULN 
Delay study medication until drug-induced liver injury can be ruled out.  
If drug-induced liver injury is ruled out, the subject should be treated 
accordingly, and resumption of study drug may occur after discussion 
between the Investigator and Sponsor.  
If drug-induced liver injury cannot be ruled out from diagnostic workup, 
permanently discontinue study treatment. 
Monitor AST/ALT and total bilirubin twice weekly until resolution or 
return to baseline. 

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Worst Toxicity 
NCI-CTCAE v5.0 Grade  
(unless otherwise 
specified) 
Management Guidelines for DS-1062a 
AST or ALT 
Grade 2 (>3.0 – 5.0 × 
ULN if baseline was 
normal; >3.0 – 5.0 × 
baseline if baseline was 
abnormal) 
No action for Grade 2 AST/ALT.  
Grade 3 (>5.0 – 20.0 × 
ULN if baseline was 
normal; >5.0 – 20.0 × 
baseline if baseline was 
abnormal) 
In subjects without liver 
metastases and subjects 
with liver metastases and 
baseline level ≤3 × ULN 
Repeat testing within 3 days.  Delay dose until resolved to ≤Grade 1 if 
baseline ≤3 × ULN, otherwise delay dose until resolved to ≤baseline, then 
reduce by 1 level. 
Grade 3: (>8.0 – 20.0 × 
ULN if baseline was 
normal; >8.0 – 20.0 × 
baseline if baseline was 
abnormal) 
In subjects with liver 
metastases, if the baseline 
level was >3 × ULN 
Repeat testing within 3 days.  Delay dose until resolved to ≤baseline 
level, then reduce dose by 1 level. 
Grade 4 (>20.0 × ULN if 
baseline was normal; 
>20.0 × baseline if 
baseline was abnormal) 
Discontinue subject from study treatment. 
Total Bilirubin  
Grade 2 (>1.5 – 3.0 × 
ULN if baseline was 
normal; >1.5 – 3.0 × 
baseline if baseline was 
abnormal) 
If no documented Gilbert’s syndrome or liver metastases at baseline, 
delay dose until resolved to ≤Grade 1: 
• 
If resolved in ≤7 days from day of onset, maintain dose. 
• 
If resolved in >7 days from day of onset, reduce dose by 1 level. 
If documented Gilbert’s syndrome or liver metastases at baseline, 
continue study treatment. 

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Worst Toxicity 
NCI-CTCAE v5.0 Grade  
(unless otherwise 
specified) 
Management Guidelines for DS-1062a 
Grade 3 (>3.0 – 10.0 × 
ULN if baseline was 
normal; >3.0 – 10.0 × 
baseline if baseline was 
abnormal) 
If no documented Gilbert’s syndrome or liver metastases at baseline, 
repeat testing within 3 days.  Delay dose until resolved to ≤Grade 1: 
• 
If resolved in ≤7 days from day of onset, reduce dose by 1 level. 
• 
If resolved in >7 days from day of onset, discontinue DS-1062a. 
If documented Gilbert’s syndrome or liver metastases at baseline, repeat 
testing within 3 days.  Delay dose until resolved to ≤Grade 2: 
• 
If resolved in ≤7 days from day of onset, reduce dose by 1 level. 
• 
If resolved in >7 days from day of onset, discontinue DS-1062a. 
Grade 4 (>10.0 × ULN if 
baseline was normal; 
>10.0 × baseline if 
baseline was abnormal) 
Discontinue subject from study treatment. 
Gastrointestinal 
Nausea/Vomiting 
Grade 3  
If prophylaxis and supportive medications have NOT YET been 
optimized: 
• 
Delay dose until resolved to ≤ Grade 1 or baseline, optimize 
medications, and then maintain dose. 
If prophylaxis and supportive medications have ALREADY been 
optimized: 
• 
Delay dose until resolved to ≤ Grade 1 or baseline, and then reduce 
dose by 1 level. 
Grade 4 Vomiting 
Discontinue subject from study treatment 
Oral Mucositis/Stomatitis  
Treatment of oral mucositis/stomatitis 
General considerations 
Increase the frequency of bland mouth rinses up to every hour, if 
necessary and applicable. 
Provide adequate pain management (eg, doxepin 0.5%, viscous lidocaine 
2%). 
As soon as oral pain, inflammation, and/or ulceration develops, strongly 
consider steroid-containing mouth rinses (eg, dexamethasone 0.1 mg/mL, 
10 mL, 4 times daily swish for 1 to 2 minutes, then spit out or local 
alternative). 
May consider oral nystatin suspension or other topical antifungal agents 
at least 15 minutes after the steroid-containing mouthwash according to 
clinician preference based on institutional/local guidelines. 
Consider cryotherapy (ice chips or ice water held in the mouth) 
throughout the infusion. 

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Worst Toxicity 
NCI-CTCAE v5.0 Grade  
(unless otherwise 
specified) 
Management Guidelines for DS-1062a 
For severe and/or persistent events, consider referral to a dentist or oral 
surgeon. 
Grade 1 
Maintain dose. 
Optimize prophylactic and supportive medications. 
Grade 2 
Consider a dose delay or reduction if clinically indicated. 
Optimize prophylactic and supportive medications. 
Grade 3 
If prophylaxis and supportive medications have NOT YET been 
optimized: 
• 
Delay dose until resolved to ≤ Grade 1 or baseline, optimize 
medications, and then maintain dose. 
If prophylaxis and supportive medications have ALREADY been 
optimized: 
• 
Delay dose until resolved to ≤ Grade 1 or baseline, then reduce dose 
by 1 level. 
Grade 4 
Discontinue subject from study treatment. 
Diarrhoea 
Grade 3 
If prophylaxis and supportive medications per institutional guidelines 
have NOT YET been optimized: 
• 
Delay dose until resolved to ≤ Grade 1 or baseline, optimize 
medications, and then maintain dose. 
If prophylaxis and supportive medications have ALREADY been 
optimized: 
• 
Delay dose until resolved to ≤ Grade 1 or baseline, then reduce dose 
by 1 level. 
Grade 4 
Discontinue subject from study treatment. 
Other Laboratory Adverse Events 
Grade 3 
Delay dose until resolved to ≤ Grade 1 or baseline level and then reduce 
dose by 1 level, if determined by the investigator to be clinically 
significant. 
Grade 4 
Discontinue subject from study treatment. 
Other Non-laboratory Adverse Events 
Grade 3 
Delay dose until resolved to ≤ Grade 1 or baseline level and then reduce 
dose by 1 level, if determined by the investigator to be clinically 
significant. 
Grade 4 
Discontinue subject from study treatment. 
AE = adverse event; ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate 
aminotransferase; BAL = bronchoalveolar lavage; CHF = congestive heart failure; CO = carbon monoxide; 

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COVID 19 = Coronavirus disease 2019; CT = computed tomography; CTCAE = Common Terminology Criteria for 
Adverse Events; ESMO = European Society for Medical Oncology; FVC = forced vital capacity; Hb = hemoglobin; 
ILD = interstitial lung disease; IRR – infusion-related reaction; IV = intravenous; LVEF = left ventricular ejection 
fraction; CTCAE = Common Terminology Criteria for Adverse Events; PK = pharmacokinetic; SpO2 = peripheral 
oxygen saturation; ULN = upper limit of normal; WBC = white blood cell. 
All dose modifications should be based on the worst preceding toxicity. 
6.5.2. 
Docetaxel 
Dose Delay Guidelines 
Docetaxel dosing may be delayed for up to 4 weeks (28 days) from the planned date of 
administration.  If a subject is assessed as requiring a dose delay longer than 4 weeks (28 days), 
the subject must discontinue treatment with docetaxel. 
Docetaxel administration should be delayed for the following:  
Investigators should use discretion in accordance with locally approved docetaxel label and 
institutional guidance. 
• Either febrile neutropenia or neutropenia <500 cells/mm³ for greater than 1 week 
despite the use of growth factors 
• Any Grade ≥2 non-skin, drug-related adverse event (AE), except for fatigue or 
laboratory abnormalities. (Grade 2 drug-related fatigue or laboratory abnormalities do 
not require a treatment delay) 
• Any Grade 3 drug-related laboratory abnormality (except lymphopenia, neutrophil 
count, AST, ALT, or total bilirubin): 
− Grade 3 lymphopenia does not require a dose delay 
− Should not be given if neutrophil counts are <1500 cells/mm3 
− May be withheld at the discretion of the Investigator when total bilirubin > ULN 
and must be withheld when total bilirubin is ≥ 1.5 × ULN, and should not be 
given if AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase 
>2.5 × ULN 
• Any Grade 3 skin drug-related AE 
• Any AE, laboratory abnormality, or intercurrent illness that, in the judgment of the 
Investigator, warrants delaying the dose of study medication. 
Subsequent dose reductions may be required per the dose reduction and modification guidelines 
below (Table 6.5). 
Subjects receiving docetaxel may receive growth factors (including G-CSF and erythropoietin) at 
the discretion of the Investigator. 
Dose Reduction and Modification Guidelines 
Up to 2 dose reductions will be permitted for subjects receiving docetaxel (Table 6.5).  Once the 
dose of docetaxel is reduced, no dose re-escalation will be permitted.  After the permitted dose 
reductions, if further toxicity meeting the requirement for dose reduction occurs, the subject will 
be withdrawn from study treatment. 

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Table 6.5: 
Dose Reduction Levels for Docetaxel 
Starting Dosea 
First Dose Reductionb 
Second Dose Reductionb 
75 mg/m2 
55 mg/m2 or Per Investigator 
Per Investigator 
a The starting dose for all subjects randomized to docetaxel treatment arm is 75 mg/m2. 
b All dose reductions should be made in accordance with the locally approved docetaxel label and/or local clinical 
practice guidelines for docetaxel. 
Dose Delays and Modification – Docetaxel Toxicity Management Guidelines 
Subjects dosed initially at 75 mg/m2 who experience either febrile neutropenia, neutrophils 
<500 cells/mm3 for more than 1 week despite growth factor support, severe or cumulative 
cutaneous reactions, or other Grade 3/4 non-hematological toxicities during docetaxel treatment 
should have treatment withheld until resolution of the toxicity according to the dose delay 
aforementioned guidelines.  Once the toxicity resolves, docetaxel treatment may resume at 
55 mg/m2 for the remainder of the study.  One additional dose reduction or additional dose delays 
based on toxicity are at the discretion of the Investigator per local guidelines (Table 6.5).   
Note: All dose reductions should be made per Investigator in accordance with the locally 
approved docetaxel label and/or local clinical practice guidelines for docetaxel. 
Subjects who develop ≥Grade 3 peripheral neuropathy should have docetaxel treatment 
discontinued entirely.13 
Investigators should consult the locally approved manufacturer’s instructions for additional 
information on docetaxel dose adjustments due to toxicities. 
In East Asian countries, dose reductions after the starting dose of 75 mg/m2 may be considered 
per Investigator discretion depending on the patient’s condition and should be made in 
accordance with the locally approved docetaxel label and/or local clinical practice for docetaxel 
usage. 
Criteria to resume treatment with docetaxel 
Subjects may resume treatment with docetaxel when the drug-related AE(s) resolve(s) to 
Grade ≤1 or baseline, with the following exceptions: 
• Subjects may resume treatment in the presence of Grade 2 fatigue 
• Subjects who have not experienced a Grade 3 drug-related skin AE may resume 
treatment in the presence of Grade 2 skin toxicity 
• Subjects with decreased neutrophil counts, or with elevations in total bilirubin, AST 
or ALT must meet criteria for resuming treatment according to the boxed warning 
contained within the docetaxel manufacturer’s instructions.  
− Subjects with concurrent Grade 2 AST/ALT > 3 × ULN AND total bilirubin 
>2 × ULN should have treatment permanently discontinued. 
When resuming docetaxel treatment, please follow the dose reduction recommendations noted 
previously. 

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Docetaxel should be discontinued for the following: 
• Cystoid macular edema (CME) has been reported in patients treated with docetaxel.  
If CME is diagnosed, docetaxel treatment should be discontinued, and appropriate 
treatment initiated. 
• Severe hypersensitivity reactions require immediate discontinuation of docetaxel and 
initiation of appropriate therapy. 
• Severe cutaneous adverse reactions such as Stevens-Johnson syndrome, toxic 
epidermal necrolysis, and acute generalized exanthematous pustulosis have been 
reported with docetaxel treatment.  Subjects should be informed about the signs and 
symptoms of serious skin manifestations and closely monitored.  If signs and 
symptoms suggestive of these reactions appear, discontinuation of docetaxel should 
be considered. 
6.6. 
Prior and Concomitant Medications 
Therapies used from the time the subject signs the ICF for study participation to the 28-Day 
Follow-up visit (+7 days) after the last administration of DS-1062a will be recorded in the eCRF.  
Prophylactic therapies (including any required premedication), prior therapies, and all 
concomitant therapies will be recorded in the eCRF. 
All therapies received by subjects within 28 days prior to randomization will be recorded as prior 
therapies.  Concomitant therapies include all prescription, over-the-counter, and herbal remedies. 
All concomitant medications administered during the study should be recorded in the eCRF until 
the end of the Safety Follow-Up Period. Concomitant medications administered as treatment for 
drug-related AESIs should be recorded until either event resolution, end of study, study 
termination, withdrawal of consent, or subject death. 
Prohibited Therapies/Products 
With the exception of medications that are under investigation in the study (eg, standard of care, 
comparators, or combination therapies), the following medications, treatment, and procedures 
will be prohibited during the treatment period.  The Sponsor must be notified if a subject 
receives any of these during the study: 
• Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, 
antibody, retinoid, transplant, or anticancer hormonal treatment (concurrent use of 
hormones for noncancer-related conditions [eg, insulin for diabetes and hormone 
replacement therapy] is acceptable). 
• Other investigational therapeutic agents. 
• Radiotherapy (except for palliative radiation to known metastatic sites as long as it 
does not affect assessment of response or delay treatment for more than the maximum 
time specified in the dose modification section [see Section 6.5]). 
• Radiotherapy to the thorax 

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• Concomitant use of chronic systemic (IV or oral) corticosteroids or other 
immunosuppressive medications > 10 mg/day of prednisone or equivalent, except for 
managing AEs; inhaled steroids, intra-articular steroid injections, and other topical 
steroid formulations are permitted in this study. Corticosteroid mouthwash 
formulations are permitted to prevent and manage certain AEs. 
• Concomitant treatment with chloroquine or hydroxychloroquine is not allowed during 
the study treatment.   
Restricted Therapies/Products 
• The use of tobacco products, e-cigarettes and vaping is strongly discouraged but not 
prohibited. 
• The concomitant use of docetaxel with strong cytochrome P450 (CYP) 3A4 inhibitors 
should be avoided.  If the concomitant use of a strong CYP3A4 inhibitor cannot be 
avoided, a close clinical surveillance is warranted, and a dose-adjustment of docetaxel 
may be suitable during the treatment with the strong CYP3A4 inhibitor. 
• Subjects should be closely monitored when DS-1062a is concomitantly used with 
drugs that inhibit CYP3A, organic anion transporting polypeptide (OATP) 1B1, 
OATP1B3, multidrug and toxin extrusion transporter (MATE) 2-K, P-glycoprotein, 
breast cancer resistance protein (BCRP), and multidrug resistance-associated protein 
(MRP) 1.  For a list of inhibitor drugs, refer to the US Food and Drug Administration 
Table of Substrates, Inhibitors and Inducers25 or locally available sources. 
• Live vaccines are not recommended during the study, except for emergency use per 
Investigator’s discretion.  In Czech Republic only, please see Section 10.9.1 for 
text applicable to sites in Czech Republic. 
Permitted Therapies/Products 
• Hematopoietic growth factors may be used for prophylaxis or treatment based on the 
clinical judgment of the Investigator.  
− Subjects receiving docetaxel may receive growth factors (including G-CSF and 
erythropoietin) at the discretion of the Investigator. 
• Concomitant use of dietary supplements, medications not prescribed by the 
Investigator, and alternative/complementary treatments is discouraged, but not 
prohibited.  
• Prophylactic or supportive treatment of study-drug induced AEs may be used per 
Investigator’s discretion and/or institutional guidelines. 
• Based on the currently available clinical safety data, it is highly recommended that 
subjects receive prophylactic anti-emetic agents prior to infusion of DS-1062a and on 
subsequent days as needed.  Anti-emetics such as 5-hydroxytryptamine 3 antagonists 
(5-HT3), neurokinin-1 (NK-1) receptor antagonists, and steroids (eg, dexamethasone) 
should be considered and administered in accordance with the prescribing 
information or institutional guidelines. 

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• Inhaled intranasal, intraocular, intra-articular or topical steroids and adrenal 
replacement steroid doses are permitted in the absence of active autoimmune disease. 
• The use of approved bone-modifying agents (eg, bisphosphonates or receptor 
activator of nuclear factor kappa B ligand [RANKL]-targeting agents) to treat or 
control bone disease is allowed on study if a subject had initiated treatment with such 
agents at least 4 weeks prior to baseline tumor assessment.  Subjects who started the 
study without receiving bisphosphonates or RANKL-targeted agents are not allowed 
to begin treatment with those medications while receiving study treatment unless 
otherwise allowed by the protocol for the treatment of AEs or SAEs. 
• Subjects with bronchopulmonary disorders who require intermittent use of 
bronchodilators (eg, albuterol) will be included in this study.  
In Czech Republic only, please see Section 10.9.1 for modified text applicable to sites 
in Czech Republic. 

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7. 
STUDY DRUG DISCONTINUATION AND DISCONTINUATION 
FROM THE STUDY 
7.1. 
Discontinuation of Study Treatment 
The primary reason for the permanent discontinuation of DS-1062a or docetaxel treatment 
administration must be recorded.  Reasons for treatment discontinuation include: 
• Death 
• Adverse event 
• Disease progression 
• Clinical progression 
• Withdrawal by subject (to discontinue study treatment)  
− Note: this section only refers to withdrawal from treatment with DS-1062a or 
docetaxel, which is NOT the same thing as a complete withdrawal from the study.  
Discuss with the subject that they will remain in the study (ie, continue with study 
visits and assessments, including survival follow-up). 
• Physician decision 
• Lost to follow up (see Section 7.3 for details on when a subject is considered Lost to 
Follow-up) 
• Pregnancy 
• Protocol deviation (Note: Only protocol deviations that are deemed significant by the 
Investigator, with or without consultation with the Sponsor, may lead to permanent 
study drug discontinuation). 
• Study termination by Sponsor 
• Other 
After study treatment is permanently discontinued for any reason other than death or lost to 
follow-up, the subject will be treated as clinically indicated by the Investigator or referring 
physician. 
The Investigator must discuss with the subject that their decision to permanently discontinue the 
study treatment means the subject may still agree to continue into the Follow-up Period for 
onsite or modified follow-up visits.  Subjects will be followed for disease progression, if 
applicable, and survival at regularly scheduled intervals (see Table 1.2). 
Subjects who discontinue study treatment for reasons other than radiographic disease progression 
will continue to undergo tumor assessments every 6 weeks during the Follow-up Period until 
radiographic disease progression as assessed by Investigator, death, lost to follow up, or 
withdrawal of consent.   

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Once radiographic disease progression is determined by the Investigator, 1 additional tumor 
assessment performed at 6 weeks (±7 days) after Investigator-assessed radiographic disease 
progression will also be required (if BICR has not determined radiographic disease progression).   
If BICR has not determined radiographic disease progression by the time of the 1 additional 
tumor assessment performed at 6 weeks (±7 days) after Investigator-assessed radiographic 
disease progression, then sites will retrieve and send subject radiographic scans that are 
performed as part of local standard clinical practice to the central vendor.   
The Sponsor will notify the site to stop sending further scans to the central vendor when BICR 
determines radiographic disease progression OR 7 months after the date of Investigator-assessed 
radiographic disease progression for the subject, whichever occurs first.  If BICR determines 
radiographic disease progression before the Investigator, sites will not be notified to stop sending 
scans until the Investigator determines radiographic disease progression.  BICR results will not 
be shared with the site or Investigator. 
Procedures for Discontinuation from Study Drug 
The subject should be instructed to contact the Investigator or study site staff before or at the 
time study drug is discontinued. 
If a subject is discontinued from the study drug: 
• The reason(s) for discontinuation and the last dose date should be documented in the 
subject’s medical record and eCRF. 
• Due to an AE, the Investigator will follow the subject until the AE has resolved or 
stabilized. 
• An EOT evaluation should be performed as described in the Schedule of Events 
(Table 1.2). 
• A safety follow-up evaluation should be performed approximately 28 days (+7 days) 
after the last dose of study drug as described in the Schedule of Events (Table 1.2). 
• If subject has not discontinued due to disease progression, continue tumor 
assessments until disease progression, death, lost to follow-up, or withdrawal of 
consent, and survival as described in the Schedule of Events (Table 1.2). 
• LTSFU evaluations will be performed to assess survival as described in the Schedule 
of Events (Table 1.2). 
The Investigator will complete and report the observations as thoroughly as possible up to the 
date of discontinuation, including the date of last dose.  All procedures specified for the EOT 
visit will be conducted.  See Table 1.2 for specific EOT procedures. 
If a subject does not agree to continue to come to the study site, then a modified follow-up must 
be arranged to ensure the continued collection of endpoints and safety information.  Options for 
modified follow-up are noted below. 

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Modified Follow-up Options 
The following modified follow-up options can be offered to the subject who does not agree to 
study visits at the study site.  If a subject does not come back to the study site, every effort 
should be made to contact the subject to gain required information, such as the approaches listed 
below.  
• Study personnel contacting the subject by telephone. 
• Study personnel contacting an alternative person (eg, family member, spouse, partner, 
legal representative, physician, or other healthcare provider). 
• Study personnel accessing and reviewing the subject’s medical information from 
alternative sources (eg, doctor’s notes, hospital records). 
Dates of the modified follow-up contact(s) should be recorded.  See Section 7.2 for definition of 
withdrawal by subject from the study (ie, withdrawal of consent). 
7.2. 
Subject Withdrawal/Discontinuation from the Study 
Subjects may discontinue from the study for any of the following reasons: 
• Death. 
• Withdrawal by subject (discontinuation from the study)  
− NOTE: this indicates that the subject withdraws consent and refuses to undergo 
any further study procedures.  In such cases, subjects will be asked to be followed 
for long-term survival only (eg, study personnel contacting the subject by 
telephone).  Subjects who agree to survival follow-up only will be documented by 
the site in the source document and in the eCRF. 
• Lost to follow-up (see Section 7.3 for details on when a subject is considered lost to 
follow-up). 
• Study termination by Sponsor. 
• Other. 
Reason for study discontinuation and date of last contact will be recorded on the eCRF.   
If the reason for study discontinuation is the death of the subject, the options for categorizing the 
primary cause of death are progressive disease or AE.  If the reason of death is unknown, every 
effort should be made to obtain the primary cause of death.  Only 1 AE will be recognized as the 
primary cause of death. 
Only subjects who refuse all of the following methods of follow-up will be considered to have 
withdrawn consent from study participation (ie, from the interventional portion and follow-up): 
• Attendance at study visits per protocol. 
• Study personnel contacting the subject by telephone. 
• Study personnel contacting an alternative person. 
• Study personnel accessing and reviewing the subject’s medical information from 
alternative sources. 

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If the subject refuses all of the aforementioned methods of follow-up, the Investigator should 
personally speak to the subject to ensure the subject understands all of the potential methods of 
follow-up. If the subject refuses routine follow up, the Investigator should discuss with the 
subject if sparse survival follow up by telephone or verification of medical records is permitted 
prior to database locks. If the subject continues to refuse all potential methods of follow up, the 
Investigator will document this as a withdrawal of consent (from the interventional portion and 
follow-up). 
Withdrawal Procedures 
If a subject is withdrawn from both the interventional and follow-up portions of the study: 
• The Investigator will complete and report the observations as thoroughly as possible 
up to the date of withdrawal, including the date of last dose, date of last contact, and 
the reason for withdrawal. 
• Any disclosure of future information is also withdrawn; the Sponsor may retain and 
continue to use any data collected before such a withdrawal of consent. 
• The subject may request destruction of any samples taken and not tested, and the 
Investigator must document this in the site study records. 
• Study site personnel may use local, regional, and national public records (in 
accordance with local law) to monitor vital status. Knowledge of the vital status at 
study end in all subjects is crucial for the integrity of the study. 
See Schedule of Events (Table 1.2) for data to be collected at the time of study discontinuation 
and follow-up and for any further evaluations that need to be completed. 
7.3. 
Lost to Follow-Up 
A subject will be considered lost to follow-up if s/he fails to return for 2 consecutive scheduled 
visits per the Schedules of Events and is unable to be contacted by the study site staff.  Before a 
subject is deemed lost to follow-up, the Investigator or designee will make every effort to regain 
contact with the subject (where possible, 3 telephone calls, texts, or emails, and if necessary, a 
certified letter to the subject’s last known mailing address or local equivalent methods).  These 
contact attempts should be documented. 
If direct contact with the subject is not possible the site must make every effort to collect survival 
status from public records (eg, obituaries, death certificates, etc.) in accordance with local laws. 
Knowledge of the vital status at study end in all subjects is crucial for the integrity of the study. 

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8. 
STUDY PROCEDURES 
See Schedule of Events in Table 1.1 for study procedures during the Screening Period and the 
first 3 cycles of Treatment Period, and Table 1.2 for study procedures during Cycle 4 and the 
subsequent cycles of the Treatment Period, EOT, and the Follow-up Period. 
8.1. 
Eligibility Assessment 
Review the subject’s demographics, medical and NSCLC history, prior medications, nondrug 
therapies and radiotherapy, vital signs, and results of tests (physical examination, height, weight, 
peripheral oxygen saturation (SpO2), ECOG PS, ophthalmologic assessment, 12-lead ECG in 
triplicate, ECHO/MUGA scan, and laboratory assessments) and compare against the eligibility 
criteria (Section 5.1 and Section 5.2).  See Section 5.3 for rescreening. 
Informed Consent 
Before a subject’s participation in the study, it is the Investigator’s responsibility to obtain freely 
given consent, in writing and with the date specified, from the subject after adequate explanation 
of the aims, methods, anticipated benefits, and potential hazards of the study and before any 
protocol-specific procedures or any study drugs are administered.  Subjects should be given the 
opportunity to ask questions and receive responses to their inquiries and should have adequate 
time to decide whether to participate in the study.  The written ICF should be prepared in the 
local language(s) of the potential subject population.  See Section 10.1.2 for additional details. 
Qualifying Tumor Tissue Specimen 
A pre-treatment biopsy procedure to collect fresh tumor tissue from the primary or metastatic 
lesions performed after termination of the most recent anticancer treatment is required for all 
subjects.  Alternatively, tumor tissue previously retrieved from a biopsy procedure performed 
within 2 years prior to the subject signing the informed consent that has a minimum of 
10 × 4 micron sections or a tissue block equivalent of 10 × 4 micron sections (minimum of 
10 slides at 4 microns; 20 slides preferred) may be substituted for the pre-treatment biopsy 
procedure during Screening.  If a documented law or regulation prohibits (or does not approve) 
sample collection, then such samples will not be collected/submitted.  Availability of previously 
collected tissue must be documented during Screening.  Biopsies may be collected from a lesion 
that has been irradiated, provided that it can be documented that the lesion has 
increased/appeared since radiation occurred and that the biopsy is collected at least 3 months 
after radiation.   
Results from the TROP2 testing or any other results of the pre-treatment tumor biopsy will not 
be used to determine eligibility for the study.  Although baseline fresh biopsies taken from 
metastatic lesions prior to the date of subject informed consent are acceptable, collection during 
the Screening Period using Sponsor-provided neutral-buffered formalin in kits is preferred to 
standardize tissue fixation for subsequent analysis. 
Previously collected tissue samples from surgery, endoscopy, or core needle biopsy already 
collected and formalin-fixed paraffin-embedded may be used.  Tissue samples can be 
formalin-fixed paraffin-embedded tissue block(s) prepared by the standard procedure at the study 
site.  

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Additional information on tumor tissue collection, processing, and immediate shipping 
procedures is included in the Study Laboratory Manual. 
Non-Small Cell Lung Cancer History 
Subject’s NSCLC history will be obtained by the Investigator or a qualified designee.  The 
subject must have pathologically documented NSCLC that is Stage IIIB, IIIC or Stage IV 
NSCLC disease at the time of randomization (based on the American Joint Committee on 
Cancer, Eighth Edition).  
Actionable Mutation Status 
Subjects without actionable genomic alterations must have documented negative test results for 
EGFR and ALK genomic alterations to be randomized in the study.  If test results for EGFR and 
ALK are not available, subjects are required to undergo testing performed locally for these 
genomic alterations.  As ROS1, NTRK, and BRAF genomic alterations in NSCLC are rare, 
known status is not required for randomization and it will be assumed the tumor is wild type for 
these genes if unknown. 
Subjects with actionable genomic alterations must have one or more documented known 
alterations in EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET to be 
randomized in the study. 
General Medical History and Baseline Conditions 
Subject’s medical history will be obtained by the Investigator or a qualified designee. 
Untoward medical occurrence (including clinically relevant laboratory values that are not 
symptoms of NSCLC/vital signs that are out of range) that were diagnosed or known to exist 
prior to signing the ICF will be recorded on the General Medical History and Baseline 
Conditions eCRF, not the Adverse Event eCRF.  Record the start date of any medical occurrence 
that started after the ICF was signed and is ongoing at the time of the first dose of DS-1062a or 
docetaxel on the General Medical History and Baseline Conditions eCRF. 
Demographics 
Review the subject’s demographics against the eligibility criteria. 
Human Immunodeficiency Virus Antibody Test 
Perform an HIV antibody test as required by local regulations or independent Institutional 
Review Board (IRB)/Ethics Committee (EC).  HIV antibody test results can be used if performed 
within 120 days before enrollment. 
Hepatitis Screening 
HbsAg and HCV antibody testing must be performed prior to enrollment (if HCV antibody is 
positive, test HCV RNA).  Subjects with known active hepatitis or uncontrolled hepatitis B 
and/or hepatitis C infection and who are positive for HBV or HCV based on the evaluation of 
results of tests for hepatitis B (HbsAg, anti-HBs, anti-HBc, or HBV DNA) and/or hepatitis C 
infection (as per HCV RNA) will be excluded except those meeting certain conditions specified 
under Exclusion Criterion 14 (Section 5.2).  HBsAg and HCV antibody test results can be used if 
performed within 120 days before enrollment.   

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Patient-reported Outcomes 
Patient-reported outcome (PRO) assessments will include: 
• The European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire (EORTC-QLQ-C30) 
• The EORTC Quality of Life Questionnaire Lung Cancer-13 (EORTC-QLQ-LC13; 
except questions 36 and 37) 
• The EuroQol Questionnaire- 5 dimensions-5 levels (EQ-5D-5L) 
• The Patient-Reported Outcomes version of the Common Terminology Criteria for 
Adverse Events (PRO-CTCAE) 1-3; 24; 28-29; 51; 74 
8.2. 
Randomization 
After all Screening procedures are performed, results of Screening tests are available 
(ie, between the Screening visit and randomization), and subjects are confirmed to meet all 
eligibility criteria, eligible subjects will be randomized in a 1:1 ratio to DS-1062a 6.0 mg/kg or 
the control treatment, docetaxel 75 mg/m2. 
Randomization will be performed by an IRT.  Randomization will be stratified by documented 
actionable genomic alteration (present versus absent), histology (squamous versus 
nonsquamous), most immediate prior therapy included anti-PD-1/anti-PD-L1 immunotherapy 
(yes versus no) and geographical region (US/Japan/Western Europe versus ROW).  No crossover 
between study treatment arms will be allowed.  
If subjects do not meet eligibility criteria on the day of randomization, they will not be 
randomized.   
Subjects must receive the study drug within 3 days of randomization or on the same day as 
randomization.   
For subjects randomized to receive DS-1062a treatment, the subject’s weight at screening will be 
used as the baseline weight to calculate the initial dose of DS-1062a.  If during the course of 
treatment, the subject’s weight changes by ±10% of the baseline weight, the dose will be 
recalculated.  After the recalculation, the recalculated subject’s weight will be used as the new 
“baseline” weight.  The site may follow local institutional policy for re-calculating dose based on 
weight changes less than 10%.  The subject weight and BSA at each cycle will be documented in 
the eCRF. 
For subjects randomized to receive docetaxel treatment, the subject’s BSA must be calculated for 
the initial dose and then recalculated, and the docetaxel dose adapted accordingly, before each 
subsequent cycle.  The subject weight and calculated BSA at each cycle will be documented in 
the eCRF.  Investigators should consult the local manufacturer’s instructions for docetaxel for 
complete prescribing information (including warnings, precautions, contraindications, and 
adverse reactions) and follow institutional guidelines/procedures for dose calculation and 
administration of docetaxel.19  For instructions for storage and docetaxel infusion preparation, 
consult the study Pharmacy Manual. 

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8.3. 
Efficacy Assessments 
Radiographic Tumor Assessments 
Radiographic tumor assessments will include all known or suspected sites of disease, as per 
RECIST v1.1 (Section 10.4).  Imaging must include chest and abdomen CT or MRI scans, and 
brain CT or MRI scan at baseline (Screening) for all subjects.  Subjects with brain metastases at 
baseline should have brain MRI or CT scan performed every 6 weeks (±7 days) from 
randomization.  Additional brain imaging may be performed as needed clinically. 
The CT scans should be performed with contrast agents unless contraindicated for medical 
reasons; follow the local label/package insert/summary of product characteristics or institutional 
guidelines for allergic reactions to contrast agents.  
Baseline tumor assessment must be performed within 28 days prior to randomization.  A tumor 
assessment performed for the assessment of disease progression on the prior therapy will be 
acceptable as baseline if performed within 28 days of randomization.   
A complete set of the scans is required in this study (see Section 8.3).  Perform radiographic 
tumor assessments using spiral CT or MRI with ≤5 mm cuts unless another modality of disease 
assessment is necessary for the lesions. 
Antitumor activity will be assessed by Investigator at baseline (Screening) and every 6 weeks 
(±7 days) from randomization independent of treatment cycle until radiographic disease 
progression, death, lost to follow up, or withdrawal of consent regardless of discontinuation of 
study treatment or initiation of new anticancer therapy (Table 1.1 and Table 1.2).  Tumor 
assessments will continue until Investigator-assessed radiographic disease progression is 
determined, regardless of study treatment discontinuation or start of new anticancer therapy.   
Subjects who discontinue study treatment for reasons other than radiographic disease progression 
will continue to undergo tumor assessments every 6 weeks during the Follow-up Period until 
radiographic disease progression as assessed by Investigator, death, lost to follow-up, or 
withdrawal of consent.  One additional tumor assessment performed at 6 weeks (±7 days) after 
Investigator-assessed radiographic disease progression will also be required (if BICR has not 
determined radiographic disease progression).   
Imaging timing should follow calendar days.  In addition, radiographic tumor assessments will 
also be conducted whenever disease progression is suspected (eg, symptomatic deterioration).  
Tumor measurements will be performed as per RECIST v1.1 (see Section 10.4).  
The same imaging technique (CT or MRI) used to characterize each identified and reported 
lesion at baseline will be used in the subsequent tumor assessments.  
Bone scan (bone scintigraphy) or 18F-fluorodeoxyglucose positron emission tomography/CT is 
required at baseline.  If bone metastases are present at baseline, subjects should have bone scan 
(bone scintigraphy) or 18 FDG PET/CT or CT/MRI every 6 weeks (±7 days) from 
randomization.  Otherwise, follow-up bone imaging is required only if new bone metastases are 
suspected.  When disease progression in the bone or new lesion in the bone is suspected, 18F 
FDG PET/CT should be used to determine disease progression.   

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When tumor assessment at a visit is performed over multiple days, the date of response (CR, PR, 
stable disease, Non-CR/nonprogressive disease [PD; subjects with non-target lesions only], or 
not evaluable) should be recorded as the date of the last radiographic evaluation included in the 
series for that assessment, and the date of progression should be recorded as the date of the 
earliest radiographic evaluation included in the series for that assessment.  
Measurable or evaluable lesions that have been previously irradiated will not be considered 
target lesions unless increase in size has been observed after completion of radiation therapy.  
BICR Radiographic Tumor Assessment  
Radiographic imaging scans will be sent to a central imaging vendor for BICR assessment.  Sites 
will send subject scans to the central imaging vendor after each tumor assessment visit.  If BICR 
has not determined radiographic disease progression by the time of the 1 additional tumor 
assessment performed at 6 weeks (±7 days) after Investigator-assessed radiographic disease 
progression, then sites will retrieve and send subject radiographic scans that are performed as 
part of local standard clinical practice to the central vendor during the subject’s follow-up, or as 
part of subsequent therapy, including investigational agents, until BICR determines radiographic 
disease progression.  The Sponsor will notify the site to stop sending further scans to the central 
vendor when BICR determines radiographic disease progression OR until 7 months after the date 
of Investigator-assessed radiographic disease progression for the subject, whichever occurs first.  
If BICR determines radiographic disease progression before the Investigator, sites will not be 
notified to stop sending scans until the Investigator determines radiographic disease progression.  
It is recommended that sites continue to follow a scanning interval frequency of every 6 weeks 
(±7 days) during the standard of practice follow-up of the subject as long as it is not interfering 
with the subject’s standard of care.  The same imaging technique (CT or MRI) used to 
characterize each identified and reported lesion at baseline should be used in the subsequent 
tumor assessments.  For further instructions, refer to the Imaging Site Manual which will be 
provided to the site. 
The results of BICR assessment of the subject scans will not be shared with the site or 
Investigator.  The Investigator will manage the subject and make treatment decisions based 
solely on Investigator/local assessment and will be completely independent of BICR. 
The results of BICR-assessed tumor response will be used for the primary analysis of PFS in this 
study (see Section 3). 
Response Assessment 
Assessment of response will be made by BICR and the Investigator based on RECIST v1.1 
(Section 10.4).  Tumor assessments will continue regardless of study treatment discontinuation 
or start of new anticancer therapy until radiographic disease progression is assessed by 
Investigator and by BICR.  
Subsequent Anticancer Treatments 
Subsequent anticancer treatments, radiation therapy received, and surgeries performed since the 
EOT must be monitored and recorded in the eCRF until EOS.  Best response and the date of 
disease progression on subsequent therapies, as assessed by local standard clinical practice, will 
be recorded in the eCRF. 

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Disease Progression 
Subjects who discontinue study treatment for reasons other than radiographic disease progression 
or subjects who start new anticancer treatment will continue to undergo tumor assessments every 
6 weeks (±7 days) during the Follow-up Period until radiographic disease progression as 
assessed by Investigator, death, lost to follow up, or withdrawal of consent.  One additional 
tumor assessment performed at 6 weeks (±7 days) after Investigator-assessed radiographic 
disease progression will also be required (if BICR has not determined radiographic disease 
progression). 
Best response and the date of disease progression on subsequent therapies, as assessed by local 
standard clinical practice, will be recorded in the eCRF regardless of subsequent anticancer 
treatments.  
See BICR Radiographic Tumor Assessment for information on the collection of scans for BICR. 
Survival Follow-up 
All subjects should be followed for survival at least every 3 months after discontinuing study 
drug until EOS (see Table 1.2).  Survival monitoring will continue until the end of the study. 
To ensure accurate survival data are available at the time of any database lock, updated survival 
status may be requested during the course of the study by the Sponsor. For example, updated 
survival status may be requested prior to, but not limited to, an IDMC review. Upon Sponsor 
notification, all subjects who do not/will not have a scheduled study visit or study contact during 
the sponsor-defined period will be contacted for their survival status (excluding subjects who 
have a previously recorded death event in the collection tool). 
Assessment of Second Progression-free Survival (PFS2)  
Following the first objective progression, subjects will have their progression status recorded 
every 3 months to assess PFS2 after start of subsequent therapy.  A subject’s progression status 
is defined according to the local standard clinical practice and may involve any of: objective 
radiographic (preferred) progression, symptomatic progression, or other.  Scans will be 
performed according to the local practice and formal RECIST measurements will not be 
collected for assessment of PFS2.  The date of PFS2 assessment and Investigator opinion of 
progression status at each assessment will be recorded in the eCRF. 
8.4. 
Safety Assessments 
8.4.1. 
Adverse Event 
Method to Detect Adverse Events 
The definitions of an AE or serious adverse event (SAE) can be found in Section 10.5.  AEs may 
be directly observed, reported spontaneously by the subject, or collected by questioning the 
subject (or, when appropriate, by a caregiver, surrogate, or the subject’s legally authorized 
representative) at each study visit.  Subjects should be questioned in a general way, without 
asking about the occurrence of any specific symptoms.  The Investigator must assess all AEs to 
determine seriousness, severity, and causality.  The Investigator and any qualified designees are 

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responsible for detecting, documenting, and recording events that meet the definition of an AE or 
SAE and remain responsible for following AEs that are serious, are considered related to the 
study drug or study procedures, or that caused the subject to discontinue DS-1062a or docetaxel. 
All clinical laboratory results, vital signs, and ECG results or findings should be appraised by the 
Investigator to determine their clinical significance.  Isolated abnormal laboratory results, vital 
sign findings, or ECG findings (ie, not part of a reported diagnosis) should be reported as AEs if 
they are symptomatic, lead to study drug discontinuation, lead to dose reduction, require 
corrective treatment, or constitute an AE in the Investigator’s clinical judgment. 
Time Period for Collecting Adverse Events, including Adverse Events of Special Interest 
and Serious Adverse Events 
All SAEs occurring after the subject signs the ICF and up to 28 days (+7 days) after the last dose 
of study medication (ie, the Follow-up Period), whether observed by the Investigator or reported 
by the subject, will be recorded on the AE eCRF.  All SAEs will be followed until resolution, 
stabilization, the event is otherwise explained, or the subject is lost to follow up. 
If a tumor biopsy is needed, report any SAEs directly related to tissue Screening procedure 
(ie, tumor biopsy) along with any associated treatment.  Unless documentation of other AEs is 
required by local law, only SAEs directly related to tumor biopsy will be recorded during tissue 
Screening. 
All events of ILD regardless of severity or seriousness will be followed until resolution including 
after study treatment discontinuation.  
All non-serious AEs occurring after the subject has taken the first dose of DS-1062a or docetaxel 
until 28 days (+7 days) after the last dose of DS-1062a or docetaxel will be recorded on the AE 
eCRF. 
Exacerbation of a pre-existing medical condition and symptom after the first dose of DS-1062a 
or docetaxel including increase in severity of the symptom will be recorded as an AE on the 
Adverse Event eCRF, unless it is a condition of NSCLC. 
Reporting Procedure for Investigators 
All AEs (including AESIs and SAEs) will be reported in the AE eCRF.  All AEs (serious and 
non-serious) must be reported with the Investigator’s assessment of seriousness, severity, and 
causality to DS-1062a or docetaxel. 
Always report the diagnosis as the AE or SAE term.  When a diagnosis is unavailable, report the 
primary sign or symptom as the AE or SAE term with additional details included in the narrative 
until the diagnosis becomes available.  If the signs and symptoms are distinct and do not suggest 
a common diagnosis, report them as individual entries of AE or SAE. 
Disease-specific Adverse Events and Serious Adverse Events 
Disease progression/worsening of NSCLC will not be recorded as an AE on the AE eCRF.  
However, events associated with disease progression, such as events that are assessed by 
Investigator as unequivocally associated with worsening of underlying NSCLC (eg, events 

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related to brain metastases, spinal cord compression, bone pain, liver metastases, hepatomegaly, 
and tumor growth), may be recorded as AEs.   
Death due to disease progression should be recorded on the Death eCRF.   
8.4.1.1. 
Adverse Event Reporting 
The following types of events should be reported by the Investigator in the electronic data 
capture (EDC) within 24 hours of awareness: 
• SAEs (Section 10.5.2). 
• Hepatic events (both serious and non-serious) that meet potential Hy’s Law criteria 
(as defined in Section 8.4.1.3).  A targeted questionnaire is built within the eCRF to 
collect relevant additional information for these potential cases. 
• All potential ILD/pneumonitis cases should be reported within 24 hours, including 
both serious and non-serious potential ILD/pneumonitis cases (potential 
ILD/pneumonitis is described by the Event Adjudication Site Manual).   
• Grade ≥ 3 IRR events. 
• Grade ≥ 3 ocular surface toxicity events. 
• Grade ≥ 2 keratitis events (including keratitis, punctate keratitis, and ulcerative 
keratitis)   
Additional relevant information regarding the AESIs for DS-1062a is to be collected through the 
targeted questionnaires (TQs) within the clinical study database (eCRF): 
• For broad surveillance of ILD/pneumonitis, a pre-defined list of PTs eligible for 
adjudication as described in the Event Adjudication Site Manual are included for 
enhanced data collections; additional data for these AEs are collected via TQs of 
pulmonary toxicity. 
• For broad surveillance of IRR, selected PTs from Hypersensitivity standardized 
MedDRA queries (SMQ) and narrow and selected broad PTs from Anaphylactic 
Reaction (SMQ) are included for enhanced data collections; additional data for these 
≥ Grade 3 AEs will be collected via TQs of IRR. 
• For broad surveillance of oral mucositis/stomatitis, selected PTs under the MedDRA 
SMQs of Oropharyngeal conditions (Select Narrow PTs) and Drug reaction with 
eosinophilia and systemic symptoms syndrome (Select Broad PTs) are included for 
enhanced data collections; additional data for these AEs regardless of CTCAE grading 
will be collected via TQs of oral mucositis/stomatitis. 
• For broad surveillance of mucosal inflammation other than oral mucositis/stomatitis, the 
mucosal inflammation PT is included for enhanced data collections; additional data for 
this AE regardless of CTCAE grading will be collected via TQs of mucosal inflammation 
other than oral mucositis/stomatitis. 
• For broad surveillance of ocular surface toxicity, selected PTs under the MedDRA 
Selected PTs from Corneal disorder SMQ and select relevant PTs from Eye disorder 

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SOC; additional data for these AEs regardless of CTCAE grading will be collected via 
TQs of ocular surface toxicity. 
Overdose is always serious.  By definition, an overdose is medically important, which meets the 
seriousness criterion of important medical event.  An overdose can occur with or without an AE.  
AEs can either be serious or non-serious.  Details of the overdose including DS-1062a or 
docetaxel dosage, clinical course, associated AEs, and outcome must be captured in the Narrative 
form of the eCRF. 
Details summarizing the course of the SAE, including its evaluation, treatment, and outcome 
should be provided.  Specific or estimated dates of AE onset, treatment, and resolution should be 
included.  Medical history, concomitant medications, and laboratory data that are relevant to the 
event should also be summarized in the SAE report.  For fatal events, the SAE report should 
state whether an autopsy was or will be performed and should include the results if available.  
Source documents (including medical reports) will be retained at the study site and should not be 
submitted to the Sponsor for SAE reporting purposes. 
If using EDC for SAE reporting: Sites must complete the eCRF or Serious Adverse Event Report 
Form within 24 hours of awareness.  In the event that the eCRF is unavailable, SAEs should be 
reported by faxing or emailing the Serious Adverse Event Report Form to the Sponsor/CRO 
using the provided fax transmittal form and the appropriate fax number provided in the site’s 
country or email address.  Once EDC becomes available, sites will enter SAEs reported on the 
Serious Adverse Event Report Form into the eCRF as soon as possible.  Sites should refer to the 
eCRF Completion Guide for additional instructions. 
Sites should call the local SAE Hotline (see the Investigator site file provided to the sites) or the 
study monitor for any questions on SAE reporting. 
See Section 8.4.1 for details on the time period for collecting SAEs. 
Reporting Requirement to Sites and Regulatory Authorities 
The Sponsor or CRO will inform Investigators and regulatory authorities of any suspected 
unexpected serious adverse reactions (SUSARs) occurring in study sites or other studies of 
DS-1062a, as appropriate per institutional and/or local reporting requirements. 
The Sponsor and CRO will comply with any additional local safety reporting requirements.  The 
Investigator will assess if an AE is to be considered “unexpected” based on the Reference Safety 
Information section in the current IB.18 
Follow Up for Adverse Events and Serious Adverse Events 
The Investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated to elucidate the nature and/or causality 
of the AE or SAE as fully as possible.  This may include additional laboratory tests or 
investigations, histopathological examinations, or consultation with other health care 
professionals. 
Urgent safety queries must be followed and addressed promptly.  The Investigator will submit 
any updated SAE data to the Sponsor/CRO within 24 hours of receipt of the information.  

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Follow-up information and response to non-urgent safety queries should be combined for 
reporting to provide the most complete data possible within each follow-up report. 
8.4.1.1.1. Overdose 
An overdose is defined as the accidental or intentional administration of any dose of a product 
that is considered both excessive and medically important.  All occurrences of overdose for 
DS-1062a or docetaxel must be reported to the Sponsor within 24 hours of awareness.  Overdose 
will be reported via Serious Adverse Event Report /Overdose Form or eCRF. 
An “excessive and medically important” overdose includes any overdose in which either an 
SAE, a non-serious AE, or no AE occurs and is considered by the Investigator as clinically 
relevant, ie, poses an actual or potential risk to the subject. 
8.4.1.2. 
Adverse Events of Special Interest 
For the DS-1062a clinical program, based on the available pre-clinical data, review of the 
cumulative literature, reported toxicities for drugs with similar monoclonal antibody and payload 
of DS-1062a, and biological plausibility, ILD/pneumonitis, IRR, oral mucositis/stomatitis, 
mucosal inflammation other than oral mucositis/stomatitis, and ocular surface toxicity are 
considered to be AESIs.  
These events should be reported in the eCRF, and if applicable (see Section 8.4.1.1), within 
24 hours of the Investigator’s awareness of the event.  Additional relevant information regarding 
these AESIs regardless of seriousness will be collected through eCRF targeted questionnaires 
within the clinical study database, which includes the completion of TQs for any grades of 
ILD/pneumonitis; for ≥ Grade 3 of IRR; for any grades of oral mucositis/stomatitis, mucosal 
inflammation other than oral mucositis/stomatitis; and any grade of ocular surface toxicity. 
All AESIs, regardless of severity or seriousness, must be followed until either event resolution, 
end of study including any post-treatment follow-up (if applicable), study termination, 
withdrawal of consent, or subject death. 
The AESIs for the DS-1062a clinical program are presented below: 
Interstitial Lung Disease/Pneumonitis 
ILD/pneumonitis is considered an important identified risk based on a comprehensive 
cumulative review of the available safety data from the clinical development program, as well as 
the results of potential ILD/pneumonitis cases reviewed by the independent ILD AC, available 
data from recent epidemiology/literature, biological plausibility, and safety information from 
drugs with a similar monoclonal antibody and/or payload as DS-1062a.  Please refer to the most 
recent IB for preliminary clinical study data.18 
Management Guidance: 
ILD/pneumonitis should be ruled out if a subject develops radiographic changes potentially 
consistent with ILD/pneumonitis or develops an acute onset of new or worsening pulmonary or 
other related signs/symptoms such as dyspnea, cough, or fever.  If the AE is confirmed to have 
an etiology other than ILD/pneumonitis, follow the management guidance outlined in the 

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designated “Other Non-Laboratory Adverse Events” dose modification section of the study 
protocol.  
If the AE is suspected to be ILD/pneumonitis, treatment with study drug should be delayed 
pending further evaluations.  Evaluations should include high-resolution CT, pulmonologist 
consultation (infectious disease consultation as clinically indicated), bronchoscopy and 
bronchoalveolar lavage (BAL) if clinically indicated and feasible, pulmonary function tests 
(including FVC and CO diffusing capacity) and pulse oximetry (SpO2), clinical laboratory tests 
(arterial blood gases if clinically indicated, blood culture, blood cell count, differential white 
blood cell count, C-reactive protein, and a COVID-19 test, and 1 blood sample collection for PK 
analysis as soon as ILD/pneumonitis is suspected, if feasible).  Unless prohibited by local 
restrictions, if the subject consents and to the extent it is available, a tissue sample from a 
bronchoalveolar lavage or lung biopsy may be collected for histopathological, immuno-profiling, 
biomarker, or other study analysis relating to the safety of DS-1062a. 
If the AE is confirmed to be ILD/pneumonitis, follow the management guidance outlined in the 
designated “Pulmonary Toxicity” dose modification section of the study protocol.  
All events of ILD/pneumonitis regardless of severity or seriousness will be followed until 
resolution including after drug discontinuation.  
An autopsy in cases of Grade 5 ILD/pneumonitis is encouraged. 
Interstitial Lung Disease Adjudication Committee 
An independent ILD AC for the DS-1062a program is responsible for reviewing all cases of 
potential ILD/pneumonitis.  To ensure adequate and relevant independent evaluation, systematic 
additional data collection will be conducted for all cases that will be brought for adjudication.  
This additional data collection will cover a more in-depth relevant medical history (eg, smoking, 
radiation, chronic obstructive pulmonary disease, and other chronic lung conditions), diagnostic 
evaluation, treatment, and outcome of the event.  This data collection will be triggered based on 
a pre-defined list of preferred terms eligible for adjudication as described in the Event 
Adjudication Site Manual. 
Infusion-related Reaction  
IRR is an identified risk.  A Grade 3 IRR was reported and was assessed by an external 
consultant as anaphylaxis.  A targeted questionnaire for ≥ Grade 3 IRR will be available as an 
eCRF to collect relevant additional information for these potential cases.  All Grade ≥3 events 
of infusion-related reaction, regardless of seriousness, must be reported in the eCRF within 
24 hours.  Refer to the current IB for a summary of preliminary clinical study data.18 
Management Guidance: 
Premedication is required prior to any dose of DS-1062a and must include antihistamines and 
acetaminophen with or without glucocorticoids.  If there are any signs or symptoms of a Grade 1 
or Grade 2 IRR, the infusion of DS-1062a must be either slowed down or interrupted based on 
severity of the infusion-related reaction.  If the IRR is Grade 3 or Grade 4, or if there are any 
signs of anaphylaxis, the infusion of DS-1062a must be discontinued. 

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Oral Mucositis/Stomatitis  
Oral mucositis/stomatitis AEs are considered as identified risks and AESIs associated with 
DS-1062a treatment.   
Subjects should adhere to the following guidance: 
• Gently brush their teeth after meals and at bedtime using a soft or ultra-soft toothbrush 
(or swab) and a bland-flavored fluoride-containing toothpaste, 
• Floss their teeth every day, if able to do so without pain or causing gingival bleeding. 
• Daily use of prophylaxis with a steroid-containing mouthwash (eg, dexamethasone oral 
solution 0.1 mg/mL 10 mL 4 times daily swish for 1 to 2 minutes then spit out; or a 
similar mouthwash regimen using an alternative steroid advocated by institutional/local 
guidelines) is highly recommended. 
o Note: Subjects are allowed to take oral nystatin suspension or other topical 
antifungal agents after the steroid-containing mouthwash according to clinician 
preference based on institutional/local guidelines. 
• In the absence of a prophylactic steroid-containing mouthwash, daily use of inert, bland 
mouth rinses (eg, with a non-alcoholic and/or bicarbonate-containing mouthwash, 4 to 6 
times a day) is recommended. 
• Prophylactic cryotherapy (ice chips or ice water held in the mouth throughout the 
infusion) should also be considered. 
The following algorithm, to be followed from steps 1 to 4, may be used as a guidance to select an 
appropriate prophylaxis mouthwash: 
1. Dexamethasone mouthwash formulated at 0.5 mg/5 mL. If not available, then use→ 
2. Dexamethasone mouthwash compounded at site/locally. If not available, then use→ 
3. Other steroid-based mouthwash available at site/locally. If not available, then use→ 
4. Non-steroid mouthwash or other local mouthwash 
Recommendations for preventing and treating oral mucositis/stomatitis are available in the 
Schedules of Events (Table 1.1 and Table 1.2), study drug administration guidelines 
(Section 6.2.1), and Toxicity Management Guidelines (Table 6.4) sections of the protocol. 
Mucosal Inflammation Other Than Oral Mucositis/Stomatitis 
Mucosal inflammation AEs are considered as identified risks associated with DS-1062a 
treatment.  The category of “mucosal inflammation other than oral mucositis/stomatitis” is also 
an identified risk and an AESI. 
Ocular Surface Toxicity 
Ocular surface toxicity (eg, dry eye, keratitis) is considered an AESI associated with DS-1062a. 
Dry eye is considered as an identified risk and keratitis as a potential risk within this AESI.  
Subjects should be advised to use artificial tears daily and to avoid the use of contact lenses. 

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Recommendations for preventing and treating ocular surface toxicity are available in the 
Schedule of Events (Table 1.1 and Table 1.2), Toxicity Management Guidelines (Table 6.4), and 
Section 8.4.1.1 of the protocol. 
8.4.1.3. 
Hepatic Events 
Hepatic events (both serious and non-serious) which meet the potential Hy’s Law criteria are 
defined as an elevated (ALT or AST) ≥ 3 × ULN and an elevated TBL ≥ 2 × ULN that may 
occur either at different time points within a 3-week interval or simultaneously at any time 
during this study. A targeted questionnaire (TQ) is built within the eCRF to collect relevant 
additional information for these potential cases. If the subject discontinues DS-1062a due to liver 
enzyme abnormalities, the subject will have additional clinical and laboratory evaluations as 
described in Section 10.2 of the protocol in order to determine the nature and severity of the 
potential liver injury. 
8.4.2. 
Pregnancy 
The Sponsor must be immediately notified of any female subject who becomes pregnant while 
receiving or within 7 months of the last dose of DS-1062a or within 6 months of the last dose of 
docetaxel.  Additionally, the Sponsor must be immediately notified of any partner of a male 
subject who becomes pregnant while receiving or within 4 months of the last dose of DS-1062a 
or within 6 months of the last dose of docetaxel. 
Although pregnancy is not technically an AE, all pregnancies must be followed to conclusion to 
determine their outcome.  If a pregnancy is reported, the Investigator must inform the Sponsor 
within 24 hours of learning of the pregnancy. 
This information is important for both drug safety and public health concerns.  It is the 
responsibility of the Investigator, or designee, to report any pregnancy in a female subject or 
partner of a male subject using the Exposure In Utero (EIU) Reporting Form.  Please contact 
your study monitor to receive the EIU Reporting Form upon learning of a pregnancy.  The 
Investigator should make every effort to follow the female subject or partner of a male subject 
(upon obtaining written consent from partner) until completion of the pregnancy and complete 
the EIU Reporting Form with complete pregnancy outcome information, including normal 
delivery and induced abortion.  Any adverse pregnancy outcome, either serious or non-serious, 
should be reported in accordance with study procedures.  If the outcome of the pregnancy meets 
the criteria for immediate classification as an SAE (ie, post-partum complications, spontaneous 
or induced abortion, stillbirth, neonatal death, or congenital anomaly, including that in an aborted 
fetus), the Investigator should follow the procedures for reporting SAEs. 
Women must not get pregnant, breastfeed, or donate/retrieve ova during the study and for at least 
7 months after stopping DS-1062a or for at least 6 months after stopping docetaxel. 
Pregnancy Test 
For women of childbearing potential (as defined in Section 5.1): document the results of a 
negative serum pregnancy test.  For eligibility, if not performed as a part of routine care, a serum 
pregnancy test (within 28 days prior to randomization) must be performed.  Within 72 hours 
before Cycle 1 Day 1, a pregnancy test (urine/serum per institutional procedures) must be done 

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for all female subjects of childbearing potential (see Table 1.1).  Repeat pregnancy tests (urine or 
serum per institutional guidelines) must be performed 72 hours before infusion at each cycle, at 
the EOT visit, and at the 28-Day Safety Follow-up visit.  A positive urine pregnancy test must 
immediately be confirmed using a serum test. 
8.4.3. 
Clinical Laboratory Evaluations 
Clinical laboratory tests including hematology, blood chemistry, and pregnancy tests will be 
performed as per the Schedules of Events by the local laboratory (Table 1.1 and Table 1.2).  
Urinalysis and coagulation will be performed at Screening and as clinically indicated during the 
study.  Refer to Section 10.2 for the complete list of laboratory parameters. 
All laboratory values must be appraised by the Investigator as to clinical significance and used to 
take appropriate clinical management measures.  All abnormal laboratory values considered 
clinically significant by the Investigator should be recorded on the AE page of the eCRF.  If the 
abnormal laboratory value constitutes an SAE, an SAE should be reported in the CRF and other 
relevant procedures must be followed (see Section 8.4.1.1). 
Abnormal laboratory values (NCI-CTCAE Grade 3 or 4) occurring during the clinical study will 
be followed until repeat test results return to normal (or baseline), stabilize, or are no longer 
clinically relevant.  New or worsened clinically relevant abnormalities should be recorded as 
AEs on the Adverse Event eCRF. 
8.4.4. 
Other Safety 
Physical Examinations, Weight, and Height 
Physical examinations should be performed as per the Schedules of Events (Table 1.1 and 
Table 1.2).  A complete physical examination should include a weight measurement and an 
evaluation of the head, eyes, ears, nose, and throat and the cardiovascular, dermatological, 
musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems.  Any 
abnormality identified at baseline should be recorded on the eCRF.  At subsequent visits (or as 
clinically indicated), limited, symptom-directed physical examinations should be performed.  
Changes from baseline abnormalities should be collected in the subject’s study record.  New or 
worsened clinically relevant abnormalities should be recorded as AEs on the Adverse Event 
eCRF.  Height will be obtained once, prior to Cycle 1 Day 1 dosing. 
Vital Signs 
Vital signs will be measured and recorded as per the Schedules of Events (Table 1.1 and 
Table 1.2).  Vital signs will include the measurements of respiratory rate, pulse rate, systolic and 
diastolic blood pressures, and temperature.  Blood pressure and pulse rate will be measured after 
the subject has rested in a preferably recumbent position, or in sitting position if recumbent 
position is not possible, for 5 minutes or more and prior to laboratory draws. 
Pulse Oximetry 
SpO2 will be measured by pulse oximeter and at the same time vital signs are measured. 

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Electrocardiograms 
12-lead ECGs will be performed and recorded for every subject as per the Schedules of Events 
(Table 1.1 and Table 1.2).  The ECG will be measured after the subject has rested in a recumbent 
position for 5 minutes or more.  At Screening only, within 7 days before randomization, triplicate 
ECGs are required in close succession, no more than 5 minutes apart, and after at least 5 minutes 
of quiet rest in the supine position.   
Single ECGs will be performed per the Schedules of Events (Table 1.1 and Table 1.2) and as 
clinically indicated for all other treatment cycles.  If an ECG abnormality is detected, ECGs will 
be performed in triplicate. 
At any visit during which a subject exhibits a heart rate ≤50 bpm or other clinical indications for 
ECG, the ECG will be repeated.  Abnormal, clinically relevant findings occurring post-baseline 
will be reported as AEs.  Electrocardiograms will be transmitted electronically to a central reader 
for determination of heart rate, PR interval, RR interval, QRS amplitude, QT interval, QTcF 
interval, and any other results. 
Multigated Acquisition Scan or Echocardiogram 
MUGA/ECHO must be performed as per the Schedules of Events (Table 1.1 and Table 1.2).  
Subjects must have an LVEF ≥50% to be eligible for the study.  The same test must be used 
throughout the study. 
ECOG Performance Status 
Assess and record the subject’s ECOG PS as per the Schedules of Events (Table 1.1 and 
Table 1.2). 
Ophthalmologic Assessments 
Ophthalmologic assessments (OAs) including visual acuity testing, slit lamp examination, 
intraocular pressure measurement, fundoscopy, and fluorescein staining will be performed at 
screening, as clinically indicated, and at the end of treatment (EOT) visit by an ophthalmologist, 
or if unavailable, another licensed eye care provider. A suitable alternative to fluorescein staining 
of the cornea may be used in exceptional circumstances where fluorescein is not available. An 
ophthalmologic assessment should be considered for any ocular symptoms including, but not 
limited to, dry eye, decreased or blurred vision, foreign-body sensation, photophobia, tearing, 
pain, and eye redness. All OAs (baseline, as clinically indicated, EOT) should be documented on 
worksheets in the eCRF, and copies of all consultation reports should be enclosed in the eCRF as 
applicable.  
The ophthalmologic assessment must be performed as per the Schedules of Events (Table 1.1 
and Table 1.2) and must include a visual acuity test, intraocular pressure test, slit-lamp 
examination, fundoscopy, and fluorescein staining. Consider obtaining an ophthalmological 
assessment to ensure accurate diagnosis, event grading, appropriate treatment, and event 
resolution, as appropriate. Use of eye medications (eg, topical corticosteroids) other than 
artificial tears should be at the discretion of an ophthalmologist or if unavailable, another 
licensed eye care provider (Table 6.4). 

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Patient-reported Outcomes 
PROs will be directly reported by the subject.  PROs will be collected electronically on site at 
baseline and at home thereafter.  Subjects will be able to use apps on their own smartphones or 
personal electronic devices to access the electronic PRO questionnaires.  Paper PRO 
questionnaires may be made available under special circumstances to be approved by the 
Sponsor.  However, electronic PROs are the preferred method.  A study specific user manual for 
Monitors, site staff, and the project team will be provided which will include details on how to 
access the PRO questionnaires from the subject’s personal electronic device(s).  PRO 
questionnaires at site visits will be evaluated in the following order: EORTC-QLQ-LC13, 
EORTC-QLQ-C30, EQ-5D.  PRO-CTCAE items will be evaluated in the order they appear in 
the PRO-CTCAE item bank (1-3; 24; 28-29; 51; 74).  
The following PROs will be performed: 
• EORTC-QLQ-LC13: 13-item lung cancer-specific questionnaire module except 
questions 36 and 37 
• EORTC-QLQ-C30: assessment of the quality of life of cancer patients 
• EQ-5D-5L: standardized instrument for measuring generic health status required for 
health technology assessments 
• PRO-CTCAE: assessment of the impact of AEs on quality of life of cancer patients 
PROs must be performed as per the Schedules of Events (Table 1.1 and Table 1.2).  To allow for 
treatment delays between cycles, the timing of the questionnaires is updated in real time 
according to treatment schedules and changes that may occur. 
8.5. 
Pharmacokinetic Assessments 
Blood samples for PK analyses of DS-1062a will be obtained from subjects receiving DS-1062a 
based on the Schedules of Events (Table 1.1 and Table 1.2) at time points outlined in Table 8.1.  
In addition, a blood sample for PK will be collected as soon as ILD/pneumonitis is suspected in a 
subject.  Details on the analysis of PK assessments are provided in the statistical analysis plan 
(SAP). 
Plasma concentration-time profiles of the 3 analytes (DS-1062a ADC, total anti-TROP2 
antibody, and MAAA-1181a) will be established from blood PK samples collected from Cycle 1 
Day 1 to Cycle 8 Day 1 for the following cohorts: 
• Full PK cohort: Approximately 20 subjects receiving to-be-marketed material of 
DS-1062a.   
• Sparse PK cohort: All other subjects receiving DS-1062a will undergo sparse PK 
sampling. 
Plasma concentrations of DS-1062a, total anti-TROP2 antibody, and MAAA-1181a will be 
measured using validated assays at the bioanalytical laboratory.   

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Table 8.1: 
Pharmacokinetic Sampling Collection 
Cycles 
Days 
Full Sampling Pharmacokinetic Cohort (only 
for 20 subjects receiving to-be-marketed 
material) 
Sparse Sampling 
Pharmacokinetic Cohort 
1 
1 
Pre-dose: 
Within 8 hours before infusion  
Post-dose:  
• 
Within 30 minutes after end of infusion  
• 
3 hours (±15 minutes) after infusion start 
• 
5 hours (±15 minutes) after infusion start 
• 
7 hours (±15 minutes) after infusion start 
Pre-dose: 
Within 8 hours before 
infusion 
Post-dose:  
• 
Within 1 hour after 
end of infusion 
• 
5 hours (±1 hour) 
after infusion start 
2 
24 hours (±2 hours) after Day 1 infusion start 
None 
4 
3 days (±1 day) after Day 1 infusion start 
None 
8 
7 days (±1 day) after Day 1 infusion start 
15 
14 days (±1 day) after Day 1 infusion start 
None 
2 
1 (± 2) 
Pre-dose:  
Within 8 hours before infusion 
Post-dose:  
Within 1 hour after end of infusion 
Pre-dose:  
Within 8 hours before 
infusion 
Post-dose:  
Within 30 minutes after end 
of infusion 
3 
1 (± 2) 
Pre-dose:  
Within 8 hours before infusion 
Post-dose:  
Within 1 hour after end of infusion 
 
Pre-dose:  
Within 8 hours before 
infusion 
4 
1 (± 2) 
Pre-dose: Within 8 hours before infusion 
Post-dose: Within 1 hour after end of infusion 
6 
1 (± 2) 
Pre-dose: Within 8 hours before infusion 
Post-dose: Within 1 hour after end of infusion 
8 
1 (± 2) 
Pre-dose: Within 8 hours before infusion 
Post-dose: Within 1 hour after end of infusion  
Instructions for the collection and handling of biological samples will be included in the 
Laboratory Manual.  The actual date and time (24-hour clock time) of each sample collection 
should be recorded.   
See Section 9.5.3 for a description of the planned analyses of PK data.  
8.6. 
Biomarker and Pharmacodynamic Assessments 
Note: Unless restricted by local/site policies or country-specific regulations, blood and tissue 
collections for exploratory biomarker and pharmacogenomic analyses as described below must 
be followed, and any deviations from the protocol should be reported as protocol deviations.  

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The Sponsor must be notified of the specific local or country-specific restriction or regulation 
that applies, and the restriction or regulation must be documented appropriately in the applicable 
study files. 
Biomarker Analysis for Potential In Vitro Companion Diagnostics 
Collected samples may be assessed for the purpose of analytical validation and bridging of 
potential in vitro diagnostics such as TROP2 immunohistochemistry.  The output of the study 
will determine the ability of the companion diagnostic to classify subjects as positive for the 
biomarker with a proposed threshold in relation to clinical efficacy.  Data obtained from the 
biomarker analysis may be used to perform clinical efficacy analyses as described in the SAP.  
8.6.1. 
Exploratory Biomarker Assessments in Blood Samples 
Cell-free DNA from blood samples collected during the study to assess changes in tumor 
mutations or other genomic alterations in response to treatment will be analyzed with the intent 
of monitoring the biological or antitumor impact of treatment with DS-1062a or control therapy, 
docetaxel.  Additional candidate blood-based biomarkers may be considered as suggested by 
updated literature.  
Biomarkers will be assessed using validated assays in blood collected at the time points specified 
in the Schedules of Events (Table 1.1 and Table 1.2). 
One or more of the biomarkers may also be assessed for correlation with efficacy.  
Plasma and serum will be collected at the time points specified in the Schedules of Events 
(Table 1.1 and Table 1.2) and at the time of suspected ILD onset.  Samples may be analyzed to 
assess biomarkers predictive of ILD. 
A blood sample will be collected at the time point specified in the Schedules of Events to serve 
as a liquid biopsy to identify subjects who are likely to derive clinical benefit (Table 1.1). 
A whole blood sample will be collected at the time point specified at Cycle 1 Day 1 to serve as a 
control for whole exome sequence/whole genome sequence tissue analysis. 
Biomarker samples will be shipped to a central laboratory.  Sample collection, preparation, 
handling, storage, and shipping instructions are provided in the Laboratory Manual. 
8.6.2. 
Exploratory Biomarker Assessments in Tumor Tissues 
Biomarker analyses will be used to investigate the effect of DS-1062a at the molecular and 
cellular level as well as to determine how changes in the biomarkers may relate to exposure and 
clinical outcomes.  Biopsies may be collected from a lesion that has been irradiated, provided 
that it can be documented that the lesion has increased/appeared since radiation occurred, and 
that the biopsy is collected at least 3 months after radiation.  The following sample for biomarker 
research is required and will be collected from all subjects in this study as specified in Table 1.1: 
• Pre-treatment biopsy procedure to collect fresh tumor tissue before study entry (see 
Inclusion Criterion 7).  If available, tumor tissue previously retrieved from a biopsy 
procedure performed within 2 years prior to the subject signing informed consent and 
that has a minimum of 10 × 4 micron sections or a tissue block equivalent to 

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10 × 4 micron sections may be substituted for the pre-treatment biopsy procedure 
during Screening.   
In addition to the biomarkers specified, exploratory biomarker research may be conducted on any 
samples. 
The sample collection information as required should be recorded on the eCRF pages and central 
laboratory requisition forms.  Detailed instructions for the collection, handling, and shipping of 
biomarker samples are outlined in the Laboratory Manual. 
8.6.3. 
Additional Exploratory Biomarker Assessments 
During the study, in addition to the biomarkers specified previously, exploratory research may be 
conducted on these collected samples.  Biomarker assessments may include but are not limited to 
immunohistochemistry or other analyses of proteins and whole exome/whole genome or targeted 
genetic analysis of DNA/RNA in tumor and blood samples.  These studies would extend the 
search for other potential biomarkers relevant to the effects of DS-1062a, cancer, and/or the 
response/resistance to the study treatment.  This may include the development of ways to detect, 
monitor, or treat NSCLC.  These additional investigations would be dependent upon clinical 
outcome, reagent, and sample availability.  
If the subject agrees, remaining samples (tumor, blood or other specimen obtained during the 
study) may be stored for a maximum of 15 years (or according to local regulations) after the 
finalization of the clinical study report (CSR) for the study at a facility selected by the Sponsor to 
enable further analysis and address scientific questions of biomarkers relevant to DS-1062a 
and/or malignancies.  The banked samples may be analyzed to design or improve methods for 
analyzing the development of diagnostic tests, characteristics of cancer, and, possibly, research 
related to other diseases that may lead to new treatments or the development of a diagnostic test 
that could be commercialized in the future to benefit other patients, or in response to a Health 
Authority request.  If performed, the results of the biomarker analyses will be reported separately 
from the CSR. 
8.6.4. 
TROP2 Immunohistochemistry Analysis 
TROP2 expression levels may be measured using an immunohistochemistry assay on all tumor 
biopsy samples collected during this study.  Results from the TROP2 testing of the tumor biopsy 
samples will not be used to determine eligibility for the study.  
8.6.5. 
Pharmacogenomic (Inherited Genetic) Analysis 
A single blood sample for pharmacogenetic analysis will be collected from each subject.  The 
pharmacogenomic blood sample will be scheduled for Cycle 1 Day 1 pre-dose (see Table 1.1) 
but may be collected at any time after the first dose of DS-1062a.  Detailed instructions for the 
collection, handling, and shipping of samples are outlined in the Laboratory Manual.   
Pharmacogenomic samples may be analyzed for genes involved in absorption, metabolism, 
elimination, safety, and efficacy of the study drug.  Additionally, samples may be analyzed for 
genes involved in study drug-related signaling pathways or to examine diseases or physiological 
processes or safety related to the study drug, such as ILD.  

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Genetic analyses will not be performed on blood samples collected for PK or safety assessments.  
Subject confidentiality will be maintained.   
If subjects agree, the remaining DNA will be stored, as outlined in Section 8.6.5.1 for performing 
future pharmacogenetic analysis.  Otherwise, all remaining DNA samples will be destroyed.  
8.6.5.1. 
Banking of Specimens for Inherited Genetic Analysis 
Procedures for the long-term preservation (banking) of blood and/or DNA specimens extracted 
from subjects’ blood samples for each subject who consented are described in the Laboratory 
Manual. 
The banked samples may be analyzed for genes involved in absorption, distribution, metabolism, 
elimination, safety, and efficacy of DS-1062a.  Additionally, samples may be analyzed for genes 
involved in DS-1062a-related signaling pathways, or to examine diseases or physiologic 
processes related to DS-1062a.  DNA samples will not be immortalized or sold to anyone.  This 
information may be useful in increasing the knowledge of differences among individuals in the 
way they respond to the study drug, as well as helping in the development of new drugs or 
improvement of existing drugs. 
Storage and Disposal of Specimens 
Banked DNA samples will be stored for a maximum of 15 years after the finalization of the CSR 
for this protocol.  These specimens will be kept for pharmacogenetic analysis in case new 
genomic or genetic information is obtained in the future regarding the response (PK or 
pharmacodynamic) to DS-1062a or in case serious adverse drug reactions are noted in a clinical 
study and pharmacogenetic analysis is to be conducted for investigation into the cause. 
During the storage period, the samples will be coded with labels having no personal information 
and will not be immortalized or sold to anyone.  Subjects will have the right to withdraw consent 
and have their sample destroyed at any time.  However, the data will not be discarded if analysis 
has been completed before the subject withdraws consent. 
Disclosure of the Results of Future Pharmacogenetic Analysis 
Because the nature and value of future pharmacogenetic analysis cannot be known at this time, 
any results obtained from research involving pharmacogenetic samples will not be disclosed to 
the subject or Investigators now or in the future. 
8.6.6. 
Immunogenicity 
Blood samples for plasma antidrug antibody (ADA) analyses will be collected from subjects 
receiving DS-1062a at the time points specified in the Schedules of Events (Table 1.1 and 
Table 1.2).  
Details for ADA plasma sampling, processing, and storage will be provided in the Laboratory 
Manual.  
The ADA testing will be performed using a validated ADA assay following tiered assay steps 
including Screening, confirmatory as well as titer determination.  If ADA is confirmed, further 
analysis to profile immunogenicity of DS-1062a (eg, neutralizing antibody assay) will be 
conducted.  Plasma concentrations of DS-1062a, total anti-TROP2 antibody, and MAAA-1181a 
may also be measured using the same ADA samples for purpose of ADA assessment.  

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9. 
STATISTICAL CONSIDERATIONS 
9.1. 
General Statistical Considerations 
The primary completion date of the PFS endpoint is the date when the pre-specified number of 
PFS events as assessed by BICR is reached.  This date is used as the DCO for the primary 
analysis of PFS. 
The primary completion date of OS endpoint is the date when the pre-specified number of deaths 
(413 OS events) is reached and at least 4 months after the last subject has been randomized.  This 
date is used as the DCO for the primary analysis of overall survival.  
All subjects still on study treatment and continuing to derive benefit at the primary completion 
date of PFS or OS will continue to follow the study Schedules of Events until the overall EOS is 
reached. 
The overall EOS will occur after all subjects have discontinued the study or have died; or an 
alternative study becomes available for subjects continuing to derive benefit from treatment with 
DS- 1062a where the drug is offered to these subjects; or the study is discontinued by the 
Sponsor for other reasons.  A final analysis may be conducted at the overall EOS.   
Descriptive statistics on continuous data will include mean, median, standard deviation, and 
range (as well as geometric mean and geometric coefficient of variation for PK data).  
Categorical data will be summarized using frequency counts and percentages.  Graphical 
summaries of the data may be presented.  Time-to-event endpoints except for time to response 
(TTR) will be reported using Kaplan-Meier estimates.  
Assessments of change from baseline to post-treatment or the ratio of post-treatment to baseline 
will include only those subjects with both baseline and post-treatment measurements.  For 
efficacy, the last assessment on or before randomization will be used as the baseline value.  For 
safety, the last assessment on or before the date of the firs dose will be used as the baseline 
value.  In general, missing data will not be imputed for the purpose of data analysis, unless 
otherwise specified.  
Data will be summarized by treatment arm. 
China Extension Study 
Subjects from China randomized after global enrollment ends will not be included in the planned 
analyses of the global study.  Details of the analyses of the data for these subjects will be 
provided in the SAP. 
9.2. 
Statistical Hypothesis 
The primary objective of the study is to compare the efficacy of DS-1062a with that of docetaxel 
and demonstrate superiority in terms of either PFS or OS for subjects with NSCLC with or 
without actionable genomic alterations previously treated with platinum-based chemotherapy 
and at least one prior line of therapy as detailed in Section 5. 

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PFS as assessed by BICR per RECIST 1.1 and OS are the 2 independent primary endpoints of 
the study.  The study will be considered positive if the hypothesis test for either of the 2 primary 
endpoints is successful. 
The following statistical hypotheses will be tested: 
• null hypothesis (H01): hazard ratio (HR) of PFS = 1 versus alternative hypothesis 
(H11): hazard ratio of PFS ≠ 1; 
• null hypothesis (H02): hazard ratio of OS = 1 versus alternative hypothesis (H12): HR 
of OS ≠ 1  
Multiplicity adjustment is specified in Section 9.5.1.4. 
9.3. 
Sample Size Determination 
A total of approximately 590 subjects will be randomized to the DS-1062a arm or the docetaxel 
arm in a 1:1 ratio (295/arm), stratified by documented actionable genomic alteration (present 
versus absent), histology (squamous versus nonsquamous), most immediate prior therapy 
included anti-PD-1/anti-PD-L1 immunotherapy (yes versus no) and geographical region (US/ 
Japan/Western Europe versus ROW).  A minimum of 15% of the total study population will 
comprise subjects with actionable genomic alterations. 
For the primary analysis of PFS, approximately 425 PFS events by BICR assessment will be 
required to have approximately 97% power to detect a hazard ratio of 0.64 at a 2-sided 
significance level of 0.008, which corresponds to an improvement of 2.1 months in median PFS 
from 3.8 months in the docetaxel arm to 5.9 months in the DS-1062a arm. 
For the primary analysis of OS, approximately 413 OS events will be required to have at least 
90% power to detect a hazard ratio of 0.72 at 2-sided significance level of 0.042, which 
corresponds to an improvement of 3.1 months in median OS from 8 months in the docetaxel arm 
to 11.1 months in the DS-1062a arm.  
Assuming an exponential distribution of OS time, a ramp-up period of 13 months and 48 subjects 
per month afterwards, the study needs a total of approximately 590 subjects (295 per arm), over 
an enrollment period of approximately 19 months.  The primary analysis for PFS as assessed by 
BICR will be performed when approximately 425 PFS events have been reached, and at least 
4 months after the last subject has been randomized.  The total of approximately 413 OS events 
would be achieved by approximately 33 months for the primary analysis of OS. 
9.4. 
Population for Analysis Sets 
Analysis Sets 
• The Safety Analysis Set will include all randomized subjects who received at least 
1 dose of study drug.  Subjects will be analyzed according to the study treatment 
received, where treatment received is the randomized study drug if the subject took at 
least 1 dose of the randomized study drug; otherwise, the first treatment received will 
be used. 

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• The Full Analysis Set (FAS) will include all subjects who have been randomized to 
the study.  Following the Intent-to-Treat principle, subjects will be analyzed 
according to the treatment and strata they have been assigned to during the 
randomization process.  FAS will be the primary analysis set for all efficacy analysis. 
• The PK Analysis Set will include all subjects in the Safety Analysis Set who had at 
least 1 PK sample with measurable plasma concentration of DS-1062a, total 
anti-TROP2 antibody, or MAAA-1181a. 
• The Per-protocol Analysis Set (PPS) will include all subjects in FAS who did not 
have major protocol violations.  Details about the major protocol deviations will be 
specified in the SAP. 
The analysis sets defined in this section are for analyses of the global study. 
9.5. 
Statistical Analysis 
The SAP will be developed and finalized before database lock and will describe the subject 
populations to be included in the analyses, and procedures for accounting for missing, unused, 
and spurious data.  This section is a summary of the planned statistical analyses of the primary 
and secondary endpoints.  Additional analytical conventions and details will be described in the 
SAP. 
9.5.1. 
Efficacy Analyses 
Table 3.1 lists the primary and secondary endpoints and their corresponding definitions.  
Additional details for the analysis and censoring rules are noted in the following sections.  
Detailed censoring rules for the primary and applicable secondary efficacy endpoints will be 
specified in the SAP.   
The FAS will be used for all efficacy analyses, unless otherwise specified.  
9.5.1.1. 
Primary Efficacy Analyses 
This study has 2 independent primary endpoints of OS and PFS as assessed by BICR.  The study 
will be considered positive if the hypothesis test for either one of these primary endpoints is 
successful.  
PFS is defined as the time from randomization to the earlier of the dates of the first radiographic 
disease progression or death due to any cause.  OS is defined as the time from randomization to 
death due to any cause.  Detailed censoring rules for PFS and OS will be specified in the SAP.  
PFS primary analysis will only be conducted after the enrollment has been completed.  
The primary efficacy analysis of PFS and OS will compare the DS-1062a and docetaxel arms, 
using a stratified log-rank test stratified by the randomization stratification factors.  
PFS and OS will be summarized and graphically presented using the Kaplan-Meier method by 
treatment arm with median and corresponding confidence interval (CI) for the median using the 
Brookmeyer and Crowley method.  In addition, the event-free probability at different time points 
(eg, 3, 6, 9, 12 months) will be estimated with corresponding CIs using the Greenwood formula 
for variance derivation. 

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The stratified cox regression model, stratified by the randomization stratification factors, will be 
fitted to estimate the hazard ratio of PFS and OS between the treatment versus the control arm 
(docetaxel) and the corresponding CI. 
9.5.1.2. 
Secondary Efficacy Analyses 
There is no key secondary endpoint of the study. 
Secondary efficacy endpoints include: PFS as assessed by Investigator, and ORR, DoR, disease 
control rate (DCR), and TTR each as assessed by BICR and by Investigator per RECIST v1.1, 
and PROs, including TTD in any of the 3 symptoms, chest pain, cough, or dyspnea.  
A brief description of each endpoint is as follows: 
• PFS is defined as the time from randomization to the earlier of the dates of the first 
radiographic disease progression or death due to any cause. 
• ORR is defined as the proportion of subjects who achieved a best overall response 
(BOR) of CR or PR. 
• DoR is defined as the time from the date of the first documentation of response (CR 
or PR) to the date of the first documentation of radiographic disease progression or 
death due to any cause, whichever occurs first.  Duration of response will be 
measured for responding subjects (CR or PR) only.  Detailed censoring rules for DoR 
will be specified in the SAP. 
• DCR is defined as the proportion of subjects who achieved a BOR of CR, PR, or SD. 
• TTR is defined as the time from the date of randomization to the date of the first 
documentation of response (CR or PR) in responding subjects. 
PFS as assessed by Investigator will be analyzed in a similar manner as PFS by BICR. 
The estimate of ORR and its 2-sided 95% exact (Clopper-Pearson26) CI will be provided by 
treatment arm. 
DoR will be analyzed in a similar manner as the primary endpoints, except that a hazard ratio 
will not be generated for DoR.  
The estimate of DCR and its 2-sided 95% exact (Clopper-Pearson26) CI will be provided by 
treatment arm. 
TTR will be summarized descriptively. 
Subgroup analyses will be conducted for PFS, OS, ORR, and DoR based on randomization 
period (before and after protocol version 4.0 to include subjects with actionable genomic 
alterations) as well as by presence of actionable genomic alterations (present versus absent).  
9.5.1.2.1. Patient-Reported Outcomes 
PRO assessments in the study will include EORTC-QLQ-C30, EORTC-QLQ-LC13 (except 
questions 36 and 37), EQ-5D-5L, and PRO-CTCAE (1-3; 24; 28-29; 51; 74). 
Time to deterioration (TTD) in any of the 3 symptoms, cough, chest pain, or dyspnea is defined 
as the time from randomization to the first clinically meaningful symptom deterioration in any of 

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the 3 symptoms, cough, chest pain, or dyspnea.  Clinically meaningful symptom deterioration is 
defined as an increase of ≥10 points in severity in the linearly transformed scale, which is 
subsequently confirmed by a second increase of ≥10 points for the same symptom at the next 
scheduled assessment or death within 21 days after the ≥10-point increase.  
The Kaplan-Meier method will be used to estimate the distribution of TTD in any of the 3 
symptoms, cough, chest pain, or dyspnea.  The median TTD along with the 95% CI will be 
presented by treatment arm.  A stratified log-rank test stratified by the randomization 
stratification factors will be used to compare the 2 treatment arms. 
Descriptive analysis will be conducted on PRO score, including subjects in the FAS without a 
missing baseline PRO score and at least 1 post-baseline score. 
All PRO instruments will be scored according to their corresponding scoring manual. 
9.5.1.3. 
Exploratory Efficacy Analyses 
The exploratory efficacy endpoint PFS2 will be analyzed in a similar manner as PFS.  Additional 
exploratory efficacy analyses, such as subgroup analyses, will be defined in the SAP.   
9.5.1.4. 
Multiplicity Adjustment 
The overall type I error rate is controlled at 2-sided 0.05 for the entire study.  PFS will be tested 
under 2-sided alpha of 0.008, and OS will be tested under 2-sided alpha of 0.042.  Alpha is 
subject to rollover between PFS and OS.  For example, the overall alpha for OS will be 2-sided 
0.05 if PFS is positive, and 2-sided 0.042 if PFS is negative.  A graphic presentation of the 
testing process and alpha splitting is shown below. 
 
IA = interim analysis; OS = overall survival; PFS = progression-free survival. 

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An IA of OS will be performed at the time of primary PFS analysis.  The nominal significance 
levels for the interim and final analyses of OS will be determined using the Lan-DeMets 
procedure with an O’Brien-Fleming stopping boundary.  The overall significance level for OS 
will be preserved at 0.042 (2 sided).  Please see Section 9.6 for more details on the IA. 
9.5.2. 
Safety Analyses 
Safety analyses in general will be descriptive and will be presented in tabular format with the 
appropriate summary statistics.  Safety analyses will be performed using the Safety Analysis Set 
and subjects will be analyzed according to their actual treatment received. 
The overall study period will be divided into 3 mutually exclusive segments for statistical 
analysis and reporting purposes:  
• Pre-treatment period: from date of informed consent (inclusive) to the start date of 
study treatment minus 1 day. 
• On-treatment period: from the start of study treatment (inclusive) to 35 days 
(ie, 28 days + 7 days) after the last dose date of study treatment (inclusive). 
• Post-treatment period: starting from 36 days after the last dose date of study 
treatment. 
Only data from the on-treatment period will be summarized, unless otherwise specified, except 
in cases where data from the pre-treatment period will be used for baseline calculation. 
Adverse Events 
AEs will be coded using MedDRA and graded using NCI-CTCAE v5.0.   
A TEAE is defined as an AE with a start or worsening date on or after the start date of study 
treatment until 35 days (ie, 28 days +7 days) since date of last dose of study treatment (ie, 
on-treatment period).  The AE summary will only include TEAEs; however, SAEs starting or 
worsening after the on-treatment period, if reported as related to the study treatment, will also be 
summarized. 
The TEAEs will be summarized using MedDRA system organ class (SOC) and preferred term.  
Additional summaries will be provided by the worst NCI-CTCAE grade, relationship to the 
study treatment (ie, regardless of relationship to study drug, study drug related), and seriousness.  
Treatment-emergent AEs associated with study drug reduction, infusion interruption, or delay; 
study treatment discontinuation; or death will also be summarized.  
If the subjects reported more than 1 AE with the same PT, the AE with the greatest severity will 
be presented.  If the subjects reported more than 1 AE with the same primary SOC, the subject 
will be counted only once with the greatest severity at the SOC level, where applicable.   
AESIs will also be summarized. 
All AEs will be listed including, but not limited to, verbatim term, PT, SOC, NCI-CTCAE grade, 
relationship to study drug, start and end dates, and outcome.  Non-TEAEs will be flagged in the 
listing.  

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Clinical Laboratory Evaluation 
Descriptive statistics will be provided for the clinical laboratory results by scheduled time of 
evaluation including the EOT visit, as well as for the change from baseline.  
Abnormal clinical laboratory results will be graded according to NCI-CTCAE v5.0, if applicable, 
and the grade will be presented in a by-subject data listing.  A shift table, presenting by treatment 
group the 2-way frequency tabulation for baseline and the worst on-treatment value according to 
the NCI-CTCAE grade, will be provided for clinical laboratory tests.  A listing of abnormal 
clinical laboratory test results deemed of clinical significance or of Grade 3 or greater will be 
generated. 
Electrocardiogram 
Descriptive statistics will be provided for the ECG measurements by scheduled time of 
evaluation including the EOT visit, as well as for the change from baseline.  In addition, the 
number and percentage of subjects with ECG interval values meeting the criteria will be 
tabulated for QT and QTcF (eg, QTc ≤450 msec, >450 to ≤480 msec, >480 msec to ≤500 msec, 
and >500 msec; and change from baseline ≥30 msec and ≥60 msec). 
A listing of ECG data will be generated. 
Vital Signs 
Descriptive statistics will be provided for the vital sign measurements by scheduled time of 
evaluation including the EOT visit, as well as for the change from baseline.  A listing of vital 
sign data will be generated. 
Other 
All other safety endpoints (eg, physical examination findings including ECOG PS, 
ECHO/MUGA, and ophthalmologic findings) will be listed and summary tables will be 
generated. 
9.5.3. 
Other Analyses 
Pharmacokinetics 
Pharmacokinetic analyses will be performed using the PK Analysis Set.  Plasma concentrations 
for DS-1062a, total anti-TROP2 antibody, and MAAA-1181a will be listed, plotted, and 
summarized using descriptive statistics at each study day, and time point. 
Full PK samples will be collected in approximately 20 subjects who receive the to-be-marketed 
drug product.  The following PK parameters will be calculated for each subject in the full PK 
sampling cohort using non-compartmental analysis of concentration time data of DS-1062a, total 
anti-TROP2 antibody, and MAAA-1181a: maximum plasma concentration, time to reach 
maximum plasma concentration, area under the plasma concentration-time curve up to the last 
quantifiable time, area under the plasma concentration-time curve during dosing interval, and if 
data permit, area under the plasma concentration-time curve up to infinity, t1/2, total body 
clearance, volume of distribution at steady state, volume of distribution based on the terminal 

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phase, and elimination rate constant associated with the terminal phase.  These parameters will 
be summarized using descriptive statistics.  Additional analyses will be defined in the SAP.  
Population PK and exposure-response (ER) analyses will be performed to characterize the 
relationships of dose, exposure, efficacy, and safety endpoints.  The effects of intrinsic (eg, body 
weight) and extrinsic covariates on PK and ER relationship will be evaluated.  The results of the 
population PK and ER analyses will be reported separately from the CSR.  
Immunogenicity 
Immunogenicity will be assessed using Safety Analysis Set unless specified otherwise. 
ADA prevalence, which is the percentage of subjects who were ADA positive at any time point 
(baseline or post-baseline), will be summarized.  ADA incidence will also be reported, which is 
the proportion of subjects having treatment-emergent ADA during the study period.  Treatment-
emergent ADA includes subjects who were ADA negative at baseline and became ADA positive 
post-baseline (treatment-induced ADA), subjects who were ADA positive at baseline and 
post-baseline but had an increase in ADA titer of at least 4-fold from baseline to post-baseline 
(treatment-boosted ADA), and subjects who had missing ADA data at baseline and were ADA 
positive post-baseline.  
Titer and neutralizing antibodies will be determined when ADA is positive.  The number of 
subjects with neutralizing antibodies will be summarized. 
Biomarkers 
Biomarkers (eg, tumor and/or blood gene expression, genomic alteration, gene signatures, 
TROP2 expression) may be summarized using descriptive statistics.  Association between 
biomarkers, efficacy and safety from DS-1062a may also be explored as appropriate. 
9.6. 
Interim Analyses 
No IA is planned for PFS.  The primary analysis for PFS as assessed by BICR will be performed 
when approximately 425 PFS events have been reached, and at least 4 months after the last 
subject has been randomized.  
OS will also be analyzed at the primary analysis of PFS (OS IA).  The overall 2-sided alpha is to 
be controlled at 0.042 for the interim OS analysis and final OS analysis using the Lan-DeMets 
alpha spending function with an O’Brien-Fleming stopping boundary.  The boundaries used at 
the interim and final OS analyses will be calculated based on the actual number of observed 
deaths.  It is projected that approximately 293 deaths will be observed at the IA, ie, 71% of 
information fraction (IF, ie, 293 out of the target 413 OS events).  The study may be stopped at 
OS IA if the pre-specified superiority boundary is crossed. 
If the study is not stopped at OS IA, then the study will continue until the required number of 
deaths (413 OS events) is reached for the primary analysis of OS at approximately 33 months 
after the first subject is randomized. 

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10. 
APPENDICES – SUPPORTING DOCUMENTATION AND 
OPERATIONAL CONSIDERATIONS 
10.1. 
Appendix 1 Regulatory and Ethical Considerations 
10.1.1. 
Regulatory Compliance 
The study protocol, the IB, available safety information, recruitment procedures 
(eg, advertisements), subject information and consent form, any subject written instructions to be 
given to the subject, information about payments and compensation available to the subjects, and 
documentation evidencing the Investigator’s qualifications should be submitted to the 
independent IRB or EC for ethical review and approval according to local regulations, prior to 
the study start.  The written approval should identify all documents reviewed by name and 
version. 
Changes in the conduct of the study or planned analysis will be documented in a protocol 
amendment and/or the SAP.  Written approval of all protocol amendments and changes to any of 
the above listed documents must be obtained from the IRB or EC. 
The Investigator should notify the IRB or EC of deviations from the protocol or SAEs occurring 
at the study site and other AE reports received from the Sponsor/CRO, in accordance with local 
procedures. 
The Sponsor will appoint a coordinating Investigator.  Among other possible duties, the 
coordinating Investigator will be responsible for reviewing the final CSR and testifying to the 
accuracy of the description of the study conduct.  Because the coordinating Investigator should 
have personal knowledge of the conduct of the study, he or she will normally be chosen from 
among those Investigators who have enrolled and treated at least 1 subject.  However, where an 
Investigator has special knowledge of the field or of the study, the coordinating Investigator can 
be chosen before enrollment of the first subject.  In all cases, the coordinating Investigator must 
be chosen before locking the database. 
Compliance Statement, Ethics, and Regulatory Compliance 
This study will be conducted in compliance with the protocol, the ethical principles that have 
their origin in the Declaration of Helsinki, the International Council for Harmonisation (ICH) 
consolidated Guideline E6 [R2] for Good Clinical Practice (GCP) (CPMP/ICH/135/95), and 
applicable regulatory requirement(s) including the following: 
• European Commission Directive and/or; 
• US Food and Drug Administration GCP Regulations: Code of Federal Regulations 
Title 21, Parts 11, 50, 54, 56, and 312 as appropriate and/or; 
• Japanese Ministry of Health, Labor and Welfare Ordinance No. 28 (27 Mar 1997) 
and/or; 
• The Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical 
Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and 
Cosmetics No. 1 (25 Nov 2014); 
• Other applicable local regulations. 

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In addition, the Investigator will inform the Sponsor in writing within 24 hours of any urgent 
safety measures taken by the Investigator to protect the study subjects against any immediate 
hazard, and of any suspected/actual serious GCP non-compliance that the Investigator becomes 
aware of. 
Supply of New Information Affecting the Conduct of the Study 
When new information becomes available that may adversely affect the safety of subjects or the 
conduct of the study, the Sponsor will inform all Investigators involved in the clinical study, 
Independent Ethics Committees/IRBs, and regulatory authorities of such information, and when 
needed, will amend the protocol and/or subject information. 
The Investigator should immediately inform the subject whenever new information becomes 
available that may be relevant to the subject’s consent or may influence the subject’s willingness 
to continue participation in the study.  The communication should be documented on medical 
records, for example, and it should be confirmed whether the subject is willing to remain in the 
study. 
If the subject information is revised, it must be re-approved by the EC/IRB.  The Investigator 
should obtain written informed consent to continue participation with the revised written 
information even if subjects were already informed of the relevant information.  The Investigator 
or other responsible personnel who provided explanations and the subject should sign and date 
the revised ICF. 
10.1.2. 
Informed Consent 
In obtaining and documenting informed consent, the Investigator should comply with the 
applicable regulatory requirements, and should adhere to GCP and to the ethical principles that 
have their origin in the Declaration of Helsinki.  The ICF and any revision(s) should be approved 
by the EC/IRB prior to being provided to potential subjects. 
The subject’s written informed consent should be documented in the subject’s medical records.  
The ICF should be signed and personally dated by the subject and by the person who conducted 
the informed consent discussion (not necessarily the Investigator).  The original signed ICF 
should be retained in accordance with institutional policy, and a copy of the signed ICF should 
be provided to the subject.  The date and time (if applicable) that informed consent was given 
must be recorded in the eCRF. 
If the subject cannot read, then according to ICH GCP Guideline, Section 4.8.9, an impartial 
witness should be present during the entire informed consent discussion.  This witness should 
sign the ICF after the subject has consented to their participation.  By signing the ICF, the 
witness attests that the information in the ICF and any other written information was adequately 
explained to and apparently understood by the subject and that informed consent was freely 
given by the subject. 
A separate special consent for inherited genetic analysis may be obtained from subjects if 
required in accordance with health authorities in their particular region/country. 
Suggested model text for the ICF for the study and any applicable subparts (PK, 
pharmacodynamic, etc.) is provided in the Sponsor’s ICF template for the Investigator to prepare 

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the documents to be used at his or her study site.  Updates to applicable forms will be 
communicated via letter from the Sponsor. 
For study sites in the US, an additional consent is required for the Health Insurance Portability 
and Accountability Act. 
10.1.3. 
Subject Confidentiality 
The Investigators and the Sponsor will preserve the confidentiality of all subjects taking part in 
the study, in accordance with GCP and local regulations. 
For European study sites, the Sponsor will observe the rules laid down in the General Data 
Protection Regulation 2016/679/EU on the protection of individuals with regard to the 
processing of personal data and the free movement of such data. 
The Investigator must ensure that the subject’s anonymity is maintained.  On the eCRFs or other 
documents submitted to the Sponsor or the CRO, subjects should be identified by a unique 
subject identification as designated by the Sponsor.  Documents that are not for submission to the 
Sponsor or the CRO (eg, signed ICF) should be kept in strict confidence by the Investigator. 
In compliance with ICH GCP Guidelines, it is required that the Investigator and institution 
permit authorized representatives of the company, of the regulatory agency(s), and the 
independent IRB/EC direct access to review the subject’s original medical records for 
verification of study-related procedures and data.  The Investigator is obligated to inform the 
subject that his/her study-related records will be reviewed by the above-named representatives 
without violating the confidentiality of the subject. 
10.1.4. 
Data Integrity and Quality Assurance 
Monitoring and Inspections 
The CRO monitor and regulatory authority inspectors are responsible for contacting and visiting 
the Investigator for the purpose of inspecting the facilities and, upon request, inspecting the 
various records of the study (eCRFs, source data, and other pertinent documents). 
The verification of adherence to the protocol; completeness, accuracy, and consistency of the 
data; and adherence to ICH GCP and local regulations on the conduct of clinical research will be 
accomplished through a combination of onsite visits by the monitor and review of study data 
remotely.  The frequency of the monitoring visit will vary based on the activity at each study 
site.  The monitor is responsible for inspecting the eCRFs and ensuring completeness of the 
study essential documents.  The monitor should have access to subject medical records and other 
study-related records needed to verify the entries on the eCRFs.  Detailed information is 
provided in the monitoring plan. 
The monitor will communicate deviations from the protocol, standard operating procedures, 
GCP and applicable regulations to the Investigator and will ensure that appropriate action(s) 
designed to prevent recurrence of the detected deviations is taken and documented. 
The Investigator agrees to cooperate with the monitor to ensure that any problems detected in the 
course of these monitoring visits are addressed to the satisfaction of the Sponsor and 
documented. 

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In accordance with ICH GCP and the Sponsor’s audit plans, this study may be selected for audit 
by representatives from the Sponsor.  Audit of study site facilities (eg, pharmacy, drug storage 
areas, laboratories) and review of study-related records will occur in order to evaluate the study 
conduct and compliance with the protocol, ICH GCP, and applicable regulatory requirements.  
The Investigator should respond to audit findings. 
In the event that a regulatory authority informs the Investigator that it intends to conduct an 
inspection, the Sponsor shall be notified immediately. 
Data Collection 
An eCRF must be completed for each subject who signs an ICF and undergoes any Screening 
procedure.  If a subject is not treated, the reason must be recorded on the eCRF.  All data 
collected during the study will be recorded in this individual, subject-specific eCRF.  Instructions 
will be provided for the completion of the eCRF and any corrections made will be automatically 
documented via an “audit trail.” 
The eCRF should be kept current to enable the study monitor to review the subject’s status 
throughout the course of the study.  Upon completion of the subject’s eCRF, it will be reviewed 
and signed off by the Investigator via the EDC system’s electronic signature.  This signature will 
indicate that the Investigator reviewed the data in the subject-specific eCRF, the data queries, 
and the site notifications and agrees with the eCRF content. 
Data Management 
Each subject will be identified in the database by a unique subject identification. 
To ensure the quality of clinical data across all study sites and subjects, a review will be 
performed by the CRO according to specifications approved by the Sponsor.  Data will be vetted 
both electronically by programmed data rules within the application and manually.  Queries 
generated by rules and raised by reviewers will be generated within the EDC application.  During 
this review, subject data will be checked for consistency, completeness and any apparent 
discrepancies. 
Data received from external sources such as central laboratories will be reconciled to the clinical 
database. 
All AEs will be coded using MedDRA.  SAEs in the clinical database will be reconciled with the 
safety database. 
All concomitant medications and prior cancer therapies will be coded using the World Health 
Organization Drug Reference Dictionary. 
10.1.5. 
Committees 
Interstitial Lung Disease Adjudication Committee 
An external ILD AC will be used for this study.  Details on the membership, responsibilities, and 
working procedures of the external ILD AC will be described in its own charter, provided as a 
separate document.  The ILD AC will adjudicate all cases of potential ILD/pneumonitis on an 
ongoing basis.  

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Adjudication of ILD/pneumonitis cases will be based on evaluation of eCRFs and source 
documents including, but not limited to, chest high-resolution CT, arterial blood gases, and 
carbon monoxide diffusing capacity.  The ILD AC will review ongoing cases of 
ILD/pneumonitis to make the final determination of ILD/pneumonitis diagnoses to guide 
Sponsor decisions regarding trial suspension or trial discontinuation and to provide assessment of 
ILD/pneumonitis prevalence at the end of the study.  Findings of the ILD AC with its 
recommendations will be provided to the Sponsor. 
Data Monitoring Committee 
An independent data monitoring committee (DMC) will be created to further protect the rights, 
safety, and well-being of subjects who will be participating in this study by monitoring the 
progress and results. The DMC will comprise qualified physicians and scientists who are not 
Investigators in the study and not otherwise directly associated with the Sponsor. 
The DMC will periodically review unblinded safety data in this study. The details about the 
reviews of the study data and other DMC processes will be described in the DMC charter. The 
DMC may recommend modification of the study protocol or study based on pre-specified rules 
described in the DMC charter. 
10.1.6. 
Study Documentation and Storage 
The Investigator will maintain a Signature List of appropriately qualified persons to whom 
he/she has delegated study duties.  All persons authorized to obtain informed consent and make 
entries and/or corrections on eCRFs will be included on the Signature List. 
Investigators will maintain a confidential Screening Log of all potential study candidates that 
includes limited information of the subjects, date, and outcome of the Screening process. 
Investigators will be expected to maintain an Enrollment Log of all subjects enrolled in the study 
indicating their assigned study number. 
Investigators will maintain a confidential Subject Identification Code list.  This confidential list 
of names of all subjects allocated to study numbers on enrolling in the study allows the 
Investigator to reveal the identity of any subject when necessary. 
Source documents are original documents, data, and records from which the subject’s eCRF data 
are obtained.  These include but are not limited to hospital records, clinical and office charts, 
laboratory and pharmacy records, diaries, microfiches, X-rays, and correspondence. 
Records of subjects, source documents, monitoring visit logs, data correction forms, eCRFs, 
inventory of study drug, regulatory documents (eg, protocol and amendments, EC/IRB 
correspondence and approvals, approved and signed ICFs, Investigator’s Agreement, clinical 
supplies receipts, distribution and return records), and other Sponsor correspondence pertaining 
to the study must be kept in appropriate study files at the study site (site-specific Trial Master 
File).  Source documents include all recordings and observations or notations of clinical 
activities and all reports and records necessary for the evaluation and reconstruction of the 
clinical study.  These records will be retained in a secure file for the period required by local 
laws or regulations or study site policy.  Prior to transfer or destruction of these records, the 
Sponsor must be notified in writing and be given the opportunity to provide further instruction. 

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Record Keeping 
The Investigator and study staff are responsible for maintaining a comprehensive and centralized 
filing system (site-specific Trial Master File) of all study-related (essential) documentation, 
suitable for inspection at any time by representatives from the Sponsor and/or applicable 
regulatory authorities.  Essential documents include: 
• Subject files containing completed eCRFs, ICFs, and supporting source 
documentation. 
• Study files containing the protocol with all amendments, IB, copies of relevant 
essential documents required prior to commencing a clinical study, and all 
correspondence to and from the independent IRB/EC and the Sponsor. 
• Records related to the study drug including acknowledgment of receipt at study site, 
accountability records and final reconciliation and applicable correspondence. 
In addition, all original source documents supporting entries in the eCRFs must be maintained 
and be readily available. 
All essential documentation will be retained by the Investigator until at least 2 years after the last 
approval of a marketing application in an ICH region and until there are no pending or 
contemplated marketing applications in an ICH region or at least 2 years have lapsed since the 
formal discontinuation of clinical development of the investigational drug.  These documents 
should be retained for a longer period, however, if required by the applicable laws or regulatory 
requirements or by an agreement with the Sponsor.  It is the responsibility of the Sponsor to 
inform the Investigator/institution as to when these documents no longer need to be retained. 
Subjects’ medical files should be retained in accordance with applicable legislation and in 
accordance with the maximum period of time permitted by the hospital, institution or private 
practice.  
No study document should be destroyed without prior written agreement between the Sponsor 
and the Investigator.  Should the Investigator wish to assign the study records to another party or 
move them to another location, he/she must notify the Sponsor in writing of the new responsible 
person and/or the new location. 
10.1.7. 
Finances 
Prior to starting the study, the Principal Investigator and/or institution will sign a clinical study 
agreement with the CRO.  This agreement will include the financial information agreed upon by 
the parties. 
Reimbursement, Indemnity, and Insurance 
The Sponsor provides insurance for study subjects to make available compensation in case of 
study-related injury. 
Reimbursement, indemnity and insurance shall be addressed in a separate agreement on terms 
agreed upon by the parties. 

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10.1.8. 
Publication, Public Disclosure Policy, and Data Sharing 
The Sponsor is committed to meeting the highest standards of publication and public disclosure 
of information arising from clinical studies Sponsored by the company.  The Sponsor will 
comply with US, EU, and Japanese policies for public disclosure of the clinical study protocol 
and clinical study results, and for sharing of clinical study data.  The Sponsor will follow the 
principles set forward in “Good Publication Practice for Communicating Company-Sponsored 
Medical Research (GPP3)”, and publications will adhere to the “Recommendations for the 
Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals” 
established by the International Council of Medical Journal Editors. 
In order to ensure compliance with the public disclosure policies and the International Council of 
Medical Journal Editors recommendations, and to protect proprietary information generated 
during the study, all publications (manuscripts, abstracts, or other public disclosure) based on 
data generated in this study must be reviewed and approved in writing by the Sponsor prior to 
submission. 
The data from this study may be shared with or used by third parties, including commercial 
partners. 
10.1.9. 
Protocol Deviations 
The Investigator must conduct the study in compliance with the protocol agreed to by the 
Sponsor and, if required, by the regulatory authority(ies), and which was given 
approval/favorable opinion by the ECs/IRBs. 
A deviation to any protocol procedure or waiver to any stated criteria will not be allowed in this 
study except where necessary to eliminate immediate hazard(s) to the subject. 
The Sponsor must be notified of all major deviations to the protocol (eg, inclusion/exclusion 
criteria, dosing, or missed study visits) and in accordance with the clinical study agreement 
between the parties on an expedited basis. 
The Investigator, or person designated by the Investigator, should document and explain any 
deviation from the approved protocol. 
If a subject was ineligible or received the incorrect dose or study treatment, and had at least 
1 administration of study drug, data should be collected for safety purposes. 
If applicable, the Investigator should notify the EC/IRB of deviations from the protocol in 
accordance with local procedures. 
10.1.10. 
Study and Site Closure 
The Sponsor reserves the right to close the study site or terminate the study at any time for any 
reason at the sole discretion of the Sponsor.  Study sites will be closed upon study completion.  
A study site is considered closed when all required documents and study supplies have been 
collected and a study-site closure visit has been performed. 
The Investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 

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Reasons for the early closure of a study site by the Sponsor or Investigator may include but are 
not limited to: 
• Failure of the Investigator to comply with the protocol, the requirements of the 
EC/IRB or local health authorities, the Sponsor’s procedures, or GCP guidelines. 
• Inadequate recruitment of subjects by the Investigator. 
• Discontinuation of further study intervention development. 
Study termination may also be requested by (a) competent authority/ies. 
In the event of early termination of the study, the Sponsor will consider providing DS-1062a to 
subjects who benefit from treatment according to legal regulations in the corresponding 
countries.  Alternatively, these subjects may also be treated with standard of care per 
Investigator’s decision. 
10.1.11. 
Product Complaints 
A product complaint is any dissatisfaction with a product that may be attributed to the identity, 
quality, durability, reliability, or safety of the product.  Individuals who identify a potential 
product complaint situation should immediately report the event.  Whenever possible, the 
associated product should be maintained in accordance with the label instructions pending 
further guidance from a quality representative form the Sponsor. 
For product complaints, refer to the Pharmacy Manual for instructions and details. 
10.2. 
Appendix 2: Laboratory Tests 
The clinical laboratory tests listed in Table 10.1 are to be performed by local laboratory in this 
study. 
Table 10.1: 
Clinical Laboratory Tests 
Test 
Analytes 
 
Blood Chemistry 
albumin 
ALT 
ALP 
AST 
bilirubin (total) 
BUN  
Urea (if BUN is not available) 
calcium 
chloride 
creatinine 
cholesterol (total) 
creatine phosphokinase 
lactate dehydrogenase 
magnesium 
potassium 
protein (total) 
sodium 
uric acid 
Hematology 
hemoglobin 
hematocrit 
platelet count 
red blood cell count 
WBC count 
differential WBC count: 
basophils  
eosinophils 
lymphocytes 
monocytes 
neutrophils 

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Test 
Analytes 
 
Coagulation 
prothrombin time INR 
partial thromboplastin time and/or 
activated partial thromboplastin time 
Urinalysis 
(abbreviated) 
bilirubin 
protein 
glucose 
nitrites 
blood 
white blood cells 
pH 
specific gravity  
color 
clarity 
microscopic analyses: to be performed if 
clinically indicated or based on significant 
abnormal findings from the urine dipstick 
• red blood cells 
• white blood cells 
• bacteria 
• crystals 
• other 
 
Pregnancy test (serum or urine) 
ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase; BUN = blood 
urea nitrogen; INR = international normalized ratio; WBC = white blood cell 
10.3. 
Appendix 3: Reference Standards 
10.3.1. 
Cockcroft-Gault Equation 
The estimated creatinine clearance (CrCl; mL/min) will be calculated using the Cockcroft-Gault 
equation based on actual weight in kilograms (1 kilogram = 2.2 pounds):27 
Conventional – serum creatinine in mg/dL: 
Male: 
CrCl (mL/min) =  
Female: 
CrCl (mL/min) = 
× 0.85 
 
International System of Units (SI) – serum creatinine in μmol/L: 
Male: 
CrCl (mL/min) =  
[140 - age (in years)] × weight (in kg) 
serum creatinine (in mg/dL) × 72 
[140 - age (in years)] × weight (in kg) 
serum creatinine (in µmol/L) × 72 × 0.0113 
[140 - age (in years)] × weight (in kg) 
serum creatinine (in mg/dL) × 72 

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Female: 
CrCl (mL/min) = 
× 0.85 
10.3.2. 
New York Heart Association  
The New York Heart Association classification is summarized in Table 10.2.28   
Table 10.2: 
New York Heart Association Classifications 
Class 
Functional Capacity 
Objective Assessment 
I 
Subjects with cardiac disease but without resulting 
limitation of physical activity.  Ordinary physical activity 
does not cause undue fatigue, palpitation, dyspnea, or 
anginal pain. 
A. No objective evidence of 
cardiovascular disease. 
II 
Subjects with cardiac disease resulting in slight limitation 
of physical activity.  They are comfortable at rest.  
Ordinary physical activity results in fatigue, palpitation, 
dyspnea, or anginal pain. 
B. Objective evidence of minimal 
cardiovascular disease. 
III 
Subjects with cardiac disease resulting in marked 
limitation of physical activity.  They are comfortable at 
rest.  Less than ordinary activity causes fatigue, 
palpitation, dyspnea, or anginal pain. 
C. Objective evidence of moderately 
severe cardiovascular disease. 
IV 
Subjects with cardiac disease resulting in inability to carry 
on any physical activity without discomfort.  Symptoms of 
heart failure or anginal syndrome may be present even at 
rest.  If any physical activity is undertaken, discomfort is 
increased. 
D. Objective evidence of severe 
cardiovascular disease. 
Source: American Heart Association. Classification of Functional Capacity and Objective Assessment, Ninth edition 
March 14, 1994.  
10.3.3. 
Eastern Cooperative Oncology Group Performance Status 
The ECOG PS scale scores are summarized in Table 10.3.29 
Table 10.3: 
Eastern Cooperative Oncology Group Performance Status 
Score 
Performance Status 
0 
Fully active, able to carry on all pre-disease performance without restriction. 
1 
Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or 
sedentary nature (eg, light housework, office work). 
2 
Ambulatory and capable of all self-care, but unable to carry out any work activities.  Up and about 
more than 50% of waking hours. 
3 
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 
4 
Completely disabled.  Cannot carry on any self-care.  Totally confined to bed or chair. 
5 
Dead 
Source: Oken MM, Creech RH, Tormey DC, et al. Toxicity and Response Criteria of the Eastern Cooperative 
Oncology Group. Am J Clin Oncol. 1982;5(6):649-55. 
[140 - age (in years)] × weight (in kg) 
serum creatinine (in µmol/L) × 72 × 0.0113 

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10.3.4. 
Highly Effective Contraception 
Male and female subjects of reproductive/childbearing potential must agree to use a highly 
effective form of contraception or avoid intercourse during and upon completion of the study and 
for at least 7 months for females and for at least 4 months for males after the last dose of 
DS-1062a or for at least 6 months for males and females after the last dose of docetaxel.  
Methods considered to be highly effective contraception include:30 
• Combined (estrogen and progestogen containing) hormonal contraception associated 
with inhibition of ovulation: 
− Oral 
− Intravaginal 
− Transdermal 
• Progestogen-only hormonal contraception associated with inhibition of ovulation: 
− Oral 
− Injectable 
− Implantable 
• Intrauterine device 
• Intrauterine hormone-releasing system 
• Bilateral tubal occlusion 
• Vasectomized partner 
• Complete sexual abstinence defined as refraining from heterosexual intercourse 
during and upon completion of the study and for at least 7 months for females and for 
at least 4 months for males after the last dose of DS-1062a or for at least 6 months for 
males and females after the last dose of docetaxel. Periodic abstinence (calendar, 
symptothermal, post-ovulation methods) is not an acceptable method of 
contraception.  The reliability of sexual abstinence needs to be evaluated in relation to 
the duration of the clinical trial and the preferred and usual lifestyle of the subject. 
10.4. 
Appendix 4: Response Evaluation Criteria in Solid Tumors 
(Version 1.1.) 
Assessment of tumor responses will be performed according to revised RECIST v1.1 
guidelines.31  Some of these definitions and criteria are highlighted below. 
Measurability of Tumor at Baseline Definitions 
At baseline, tumor lesions/lymph nodes will be categorized as measurable or non-measurable as 
follows: 

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• Measurable 
Tumor lesions: Must be accurately measured in at least 1 dimension (longest diameter in 
the plane of measurement is to be recorded) with a minimum size of: 
− 10 mm by CT scan (CT scan slice thickness no greater than 5 mm). 
− 10 mm caliper measurement by clinical examination (lesions which cannot be 
accurately measured with calipers should be recorded as non-measurable). 
− 20 mm by chest X-ray. 
Measurable malignant lymph nodes: To be considered pathologically enlarged and 
measurable, a lymph node must be ≥15 mm in the short axis when assessed by CT scan 
(CT scan slice thickness is recommended to be no greater than 5 mm).  At baseline and in 
follow-up, only the short axis will be measured and followed.  See also notes below on 
“Baseline documentation of target and non-target lesions” for information on lymph node 
measurement. 
• Non-measurable 
All other lesions, including small lesions (longest diameter <10 mm or pathological 
lymph nodes with ≥10 to <15 mm short axis) as well as truly non-measurable lesions.  
Lesions considered truly non-measurable include leptomeningeal disease, ascites, pleural 
or pericardial effusion, inflammatory breast disease, lymphangitic involvement of skin or 
lung, abdominal masses/abdominal organomegaly identified by physical examination that 
is not measurable by reproducible imaging techniques. 
• Special Considerations Regarding Lesion Measurability 
Bone lesions, cystic lesions, and lesions previously treated with local therapy require 
particular comment: 
Bone lesions: 
− Bone scan, positron emission tomography (PET) scan or plain films are not 
considered adequate imaging techniques to measure bone lesions.  However, these 
techniques can be used to confirm the presence or disappearance of bone lesions. 
− Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue 
components, that can be evaluated by cross sectional imaging techniques such as 
CT or MRI can be considered as measurable lesions if the soft tissue component 
meets the definition of measurability described above. 
− Blastic bone lesions are non-measurable. 
Cystic lesions: 
− Lesions that meet the criteria for radiographically defined simple cysts should not 
be considered as malignant lesions (neither measurable nor non-measurable) since 
they are, by definition, simple cysts. 
− ‘Cystic lesions’ thought to represent cystic metastases can be considered as 
measurable lesions, if they meet the definition of measurability described above.  

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However, if non-cystic lesions are present in the same subject, these are preferred 
for selection as target lesions. 
Lesions with prior local treatment: 
− Tumor lesions situated in a previously irradiated area, or in an area subjected to 
other loco-regional therapy, are not considered measurable unless there has been 
demonstrated progression in the lesion since the therapy. 
Specifications by Methods of Measurements 
• Measurement of Lesions 
All measurements should be recorded in metric notation, using calipers if clinically 
assessed.  All baseline evaluations should NEVER be performed more than 4 weeks 
(28 days) before randomization. 
• Method of Assessment 
The same method of assessment and the same technique should be used to characterize 
each identified and reported lesion at baseline and during follow-up.  Imaging-based 
evaluation should always be done rather than clinical examination unless the lesion(s) 
being followed cannot be imaged but are assessable by clinical examination. 
CT, MRI: CT is the best currently available and reproducible method to measure lesions 
selected for response assessment.  This guideline has defined measurability of lesions on 
CT scan based on the assumption that CT slice thickness is 5 mm or less.  When CT 
scans have slice thickness greater than 5 mm, the minimum size for a measurable lesion 
should be twice the slice thickness.  MRI is also acceptable in certain situations (eg, for 
body scans). 
Tumor Response Evaluation 
• Assessment of Overall Tumor Burden and Measurable Disease 
To assess objective response or future progression, it is necessary to estimate the overall 
tumor burden at baseline and use this as a comparator for subsequent measurements. 
In this study, only subjects with measurable disease at baseline should be included in the 
study. 
• Baseline Documentation of ‘Target’ and ‘Non-Target’ Lesions 
When more than 1 measurable lesion is present at baseline all lesions, up to a total of 
2 lesions per organ and a maximum of 5 lesions total representative of all involved 
organs should be identified as target lesions (TLs) and will be recorded and measured at 
baseline (this means in instances where subjects have only 1 or 2 organ sites involved a 
maximum of 2 and 4 lesions, respectively, will be recorded). 
Target lesions should be selected on the basis of their size (lesions with the longest 
diameter), be representative of all involved organs, but in addition should be those that 
lend themselves to reproducible repeated measurements.  It may be the case that, on 
occasion, the largest lesion does not lend itself to reproducible measurement in which 

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circumstance the next largest lesion which can be measured reproducibly should be 
selected. 
Lymph nodes merit special mention since they are normal anatomical structures which 
may be visible by imaging even if not involved by tumor.  As noted above, pathological 
nodes which are defined as measurable and may be identified as TLs must meet the 
criterion of a short axis of ≥15 mm by CT scan.  Only the short axis of these nodes will 
contribute to the baseline sum.  The short axis of the node is the diameter normally used 
by radiologists to judge if a node is involved by solid tumor.  Nodal size is normally 
reported as 2 dimensions in the plane in which the image is obtained (for CT scan this is 
almost always the axial plane; for MRI the plane of acquisition may be axial, sagittal, or 
coronal).  The smaller of these measures is the short axis.  For example, an abdominal 
node which is reported as being 20 mm × 30 mm has a short axis of 20 mm and qualifies 
as a malignant, measurable node.  In this example, 20 mm should be recorded as the node 
measurement.  All other pathological nodes (those with short axis ≥10 mm but <15 mm) 
should be considered NTLs.  Nodes that have a short axis <10 mm are considered 
non-pathological and should not be recorded or followed. 
A sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) for all 
TLs will be calculated and reported as the baseline SoD.  If lymph nodes are to be 
included in the sum, then as noted above, only the short axis is added into the sum.  The 
baseline SoD will be used as reference to further characterize any objective tumor 
regression in the measurable dimension of the disease. 
All other lesions (or sites of disease) including pathological lymph nodes should be 
identified as NTLs and should also be recorded at baseline.  Measurements are not 
required, and these lesions should be followed as ‘present’, ‘absent’, or in rare cases 
‘unequivocal progression.’  In addition, it is possible to record multiple NTLs involving 
the same organ as a single item on the eCRF (eg, ‘multiple enlarged pelvic lymph nodes’ 
or ‘multiple liver metastases’). 
• Evaluation of Target Lesions 
− Complete Response (CR): Disappearance of all TLs.  Any pathological lymph 
nodes (whether target or non-target) must have reduction in short axis to <10 mm. 
− Partial Response (PR): At least a 30% decrease in the SoD of TLs, taking as 
reference the baseline SoD. 
− PD: At least a 20% increase in the SoD of TLs, taking as reference the smallest 
sum on study (this includes the baseline sum if that is the smallest on study).  In 
addition to the relative increase of 20%, the sum must also demonstrate an 
absolute increase of at least 5 mm. (Note: The appearance of 1 or more new 
lesions is also considered progression). 
− Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient 
increase to qualify for PD, taking as reference the smallest SoD while on study. 

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• Special Notes on the Assessment of Target Lesions (TLs) 
− Lymph nodes: Lymph nodes identified as TLs should always have the actual 
short axis measurement recorded (measured in the same anatomical plane as the 
baseline examination), even if the nodes regress to below 10 mm on study.  This 
means that when lymph nodes are included as TLs, the ‘sum’ of lesions may not 
be zero even if CR criteria are met, since a normal lymph node is defined as 
having a short axis of <10 mm.  For PR, SD, and PD, the actual short axis 
measurement of the nodes is to be included in the sum of TLs. 
− Target lesions that become ‘too small to measure’: While on study, all lesions 
(nodal and non-nodal) recorded at baseline should have their actual measurements 
recorded at each subsequent evaluation, even when very small (eg, 2 mm).  
However, sometimes lesions or lymph nodes which are recorded as TLs at 
baseline become so faint on CT scan that the radiologist may not feel comfortable 
assigning an exact measure and may report them as being ‘too small to measure’.  
When this occurs, it is important that a value be recorded on the eCRF.  If it is the 
opinion of the radiologist that the lesion has likely disappeared, the measurement 
should be recorded as 0 mm.  If the lesion is believed to be present and is faintly 
seen but too small to measure, a default value of 5 mm should be assigned.  
(Note: It is unlikely that this rule will be used for lymph nodes since they usually 
have a definable size when normal and are frequently surrounded by fat such as in 
the retro-peritoneum).  This default value is derived from the 5 mm CT slice 
thickness (but should not be changed with varying CT slice thickness).  The 
measurement of these lesions is potentially non-reproducible; therefore, providing 
this default value will prevent false responses or progressions based upon 
measurement error.   
If the radiologist is able to provide an actual measurement, that should be 
recorded, even if it is below 5 mm. 
− Lesions that split or coalesce on treatment: When non-nodal lesions 
‘fragment’, the longest diameters of the fragmented portions should be added 
together to calculate the TL sum.  Similarly, as lesions coalesce, a plane between 
them may be maintained that would aid in obtaining maximal diameter 
measurements of each individual lesion.  If the lesions have truly coalesced such 
that they are no longer separable, the vector of the longest diameter in this 
instance should be the maximal longest diameter for the ‘coalesced lesion.’ 
• Evaluation of Non-Target Lesions (NTLs) 
− CR: Disappearance of all NTLs and normalization of tumor marker level.  All 
lymph nodes must be non-pathological in size (<10 mm short axis). 
− Non-CR/Non-PD: Persistence of one or more NTL(s) and/or maintenance of 
tumor marker level above the normal limits. 
− PD: Unequivocal progression (see comments below) of existing NTLs.  (Note: 
the appearance of 1 or more new lesions is also considered progression). 

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• Special Notes on Assessment of Progression of Non-target Disease 
The concept of progression of non-target disease requires additional explanation as 
follows, when the subject also has measurable disease.  In this setting, to achieve 
‘unequivocal progression’ on the basis of the non-target disease, there must be an overall 
level of substantial worsening in non-target disease such that, even in presence of SD or 
PR in target disease, the overall tumor burden has increased sufficiently to merit 
discontinuation of therapy.  A modest ‘increase’ in the size of 1 or more NTLs is usually 
not sufficient to qualify for unequivocal progression status.  The designation of overall 
progression solely on the basis of change in non-target disease in the face of SD or PR of 
target disease will, therefore, be extremely rare. 
• New Lesions (NLs) 
The appearance of new malignant lesions denotes disease progression; therefore, some 
comments on detection of NLs are important.  There are no specific criteria for the 
identification of new radiographic lesions; however, the finding of a NL should be 
unequivocal: ie, not attributable to differences in scanning technique, change in imaging 
modality, or findings thought to represent something other than tumor (for example, some 
‘new’ bone lesions may be simply healing or flare of pre-existing lesions).  This is 
particularly important when the subject’s baseline lesions show PR or CR.  For example, 
necrosis of a liver lesion may be reported on a CT scan report as a ‘new’ cystic lesion, 
which it is not. 
A lesion identified on a follow-up study in an anatomical location that was not scanned at 
baseline is considered a NL and will indicate disease progression.  An example of this is 
the subject who has visceral disease at baseline and while on study has a CT or MRI of 
the brain which reveals metastases.  The subject’s brain metastases are considered to be 
evidence of PD even if he/she did not have brain imaging at baseline. 
If a NL is equivocal, for example because of its small size, continued therapy and 
follow-up evaluation will clarify if it represents truly new disease.  If repeat scans 
confirm there is definitely a NL, then progression should be declared using the date of the 
initial scan that indicated its presence. 
Evaluation of Best Overall Response 
The BOR is the best response recorded from the start of the study treatment until the EOT.  
Confirmatory measurement for CR or PR is not required in this study.  The subject’s BOR 
assignment will depend on the findings of both target and non-target disease and will also take 
into consideration the appearance of NLs. 
Time Point Response 
It is assumed that at each protocol-specified time point, a response assessment occurs.  
Table 10.4 provides a summary of the overall response status calculation at each time point for 
subjects who have measurable disease at baseline. 
All post-baseline scans must be compared with the baseline scan. 
When subjects have non-measurable, therefore non-target, disease only, Table 10.5 is to be used.   

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Table 10.4: 
Time Point Response: Subjects with Target (±Non-target) Disease 
Target Lesions 
Non-target Lesions 
New Lesions 
Overall Response 
CR 
CR 
No 
CR 
CR 
Non-CR/non-PD 
No 
PR 
CR 
Not evaluated 
No 
PR 
PR 
Non-PD or not all evaluated 
No 
PR 
SD 
Non-PD or not all evaluated 
No 
SD 
Not all evaluated 
Non-PD 
No 
NE 
PD 
Any 
Yes or No 
PD 
Any 
PD 
Yes or No 
PD 
Any 
Any 
Yes 
PD 
CR = complete response; NE = not evaluable; PD = progressive disease; PR = partial response; SD = stable disease 
Table 10.5: 
Overall Response: Subjects with Non-target Disease Only 
Non-target Lesions 
New Lesions 
Overall Response 
CR 
No 
CR 
Non-CR/non-PD 
No 
Non-CR/Non-PD 
Not all evaluated 
No 
NE 
Unequivocal PD 
Yes or No 
PD 
Any 
Yes 
PD 
CR = complete response; NE = not evaluable; PD = progressive disease;  
Missing Assessments and In-evaluable Designation 
When no imaging/measurement is done at all at a particular time point, the subject is not 
evaluable (NE) at that time point.  If only a subset of lesion measurements is made at an 
assessment, usually the case is also considered NE at that time point, unless a convincing 
argument can be made that the contribution of the individual missing lesion(s) would not change 
the assigned time point response.  This would be most likely to happen in the case of PD.  For 
example, if a subject had a baseline sum of 50 mm with 3 measured lesions and at follow-up 
only 2 lesions were assessed, but those gave a sum of 80 mm, the subject will have achieved PD 
status, regardless of the contribution of the missing lesion. 
Best Overall Response: All Time Points 
The BOR is determined once all the data for the subject are known.  The BOR when 
confirmation of CR or PR is required is displayed in Table 10.6. 

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Table 10.6: 
Overall Best Overall Response When Confirmation of CR and PR Required 
Overall Response 
 
Overall Response 
First Time Point 
Subsequent Time Point 
Best 
CR 
CR 
CR 
CR 
PR 
SD, PD or PR
a 
CR 
SD 
SD provided minimum criteria for SD duration met, 
otherwise, PD 
CR 
PD 
SD provided minimum criteria for SD duration met, 
otherwise, PD 
CR 
NE 
SD provided minimum criteria for SD duration met, 
otherwise, PD 
PR 
CR 
PR 
PR 
PR 
PR 
PR 
SD 
SD 
PR 
PD 
SD provided minimum criteria for SD duration met, 
otherwise, PD 
PR 
NE 
SD provided minimum criteria for SD duration met, 
otherwise, PD 
NE 
NE 
NE 
CR = complete response; PR = partial response; SD = stable disease; NE = not evaluable; PD = progressive disease 
a If a CR is truly met at first time point, then any disease seen at a subsequent time point, even disease meeting PR 
criteria relative to baseline, makes the disease PD at that point (since disease must have reappeared after CR).  
Best response would depend on whether minimum duration for SD was met.  However, sometimes ‘CR’ may be 
claimed when subsequent scans suggest small lesions were likely still present and in fact the subject had PR, not 
CR at the first time point.  Under these circumstances, the original CR should be changed to PR and the best 
response is PR. 
Source: Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: Revised 
RECIST guideline (version 1.1). Table 3. Euro J Can. 2009:45(2);228-47 
Special Notes on Response Assessment 
When nodal disease is included in the sum of TLs and the nodes decrease to ‘normal’ size 
(<10 mm), they may still have a measurement reported on scans.  This measurement should be 
recorded even though the nodes are normal in order not to overstate progression should it be 
based on increase in size of the nodes.  As noted earlier, this means that subjects with CR might 
not have a total sum of ‘0’ on the eCRF. 
Subjects with a global deterioration of health status requiring discontinuation of DS-1062a 
without objective evidence of disease progression at that time should be reported as ‘clinical 
progression.’  Every effort should be made to document objective progression even after 
discontinuation of treatment.  Symptomatic deterioration is not a descriptor of an objective 
response: it is a reason for stopping study drug.  The objective response status of such subjects is 
to be determined by evaluation of target and non-target disease.  If a radiographic tumor 
assessment has not been performed within 4 weeks (28 days) of the time of clinical progression, 

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then another radiographic assessment should be performed without waiting for the next regularly 
scheduled scan. 
For equivocal findings of progression (eg, very small and uncertain new lesions; cystic changes 
or necrosis in existing lesions), treatment may continue until the next scheduled assessment.  If at 
the next scheduled assessment, progression is confirmed, the date of progression should be the 
earlier date when progression was suspected. 
Frequency of Tumor Re-evaluation 
In this study, tumor measurement will be conducted at Screening, and every 6 weeks (±7 days) 
until Investigator-assessed radiographic disease progression as specified in the Schedules of 
Events or sooner if clinically indicated (see Table 1.1 and Table 1.2).  One additional tumor 
assessment performed at 6 weeks (±7 days) after Investigator-assessed radiographic disease 
progression will also be required (if BICR has not determined radiographic disease progression).  
It is recommended that sites continue to follow a scanning interval frequency of every 6 weeks 
(±7 days) during the standard of practice follow-up of the subject as long as it is not interfering 
with the subject’s standard of care.  When tumor assessments at a visit are performed over 
multiple days, the date of response (CR, PR, SD, Non-CR/Non-PD [subjects with non-target 
lesions (NTL) only] or not evaluable [NE]) should be recorded as the date of the last 
radiographic evaluation included in the series for that assessment, and the date of progression 
(PD) should be recorded as the date of the earliest radiographic evaluation included in the series 
for that assessment. 
Baseline tumor assessments must be performed within the Screening Period of 28 days prior to 
randomization. 
All efforts should be made to ensure consistency between the baseline measurements and all 
subsequent measurements in reference to utilization of scanning method, equipment, technique 
(including slice thickness and field of view), and radiographic interpreter. 
The radiographic evaluation must include CT or MRI scanning of the chest and abdomen.  Any 
additional suspected sites of disease should also be imaged.  All evaluations should meet the 
standard of care for imaging of lesions in the respective organ(s) and should conform to the 
image acquisition guidelines according to institutional standards. 
All target and non-target sites are evaluated at each time point of tumor assessment. 
10.5. 
Appendix 6: General Information – Adverse Events 
10.5.1. 
Definition of Adverse Event 
An AE is any untoward medical occurrence in a subject administered a pharmaceutical product 
and that does not necessarily have to have a causal relationship with this treatment.  An AE can 
therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for 
example), symptom, or disease temporally associated with the use of a medicinal product, 
whether or not considered related to the medicinal product.32 
It is the responsibility of Investigators, based on their knowledge and experience, to determine 
those circumstances or abnormal laboratory findings which should be considered AEs. 

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Events Meeting the AE Definition 
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (eg, ECG, radiographic scans, vital signs measurements), 
including those that worsen from baseline, considered clinically relevant in the 
medical and scientific judgment of the Investigator (ie, not related to progression of 
underlying disease). 
• Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
• New conditions detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
Events NOT Meeting the AE Definition 
• Any clinically relevant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
Investigator to be more severe than expected for the subject’s condition. 
• The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the subject’s 
condition. 
• Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
• “Lack of efficacy” or “failure of expected pharmacological action” per se will not be 
reported as an AE or SAE.  Such instances will be captured in the efficacy 
assessments.  However, the signs, symptoms, and/or clinical sequelae resulting from 
lack of efficacy will be reported as AE or SAE if they fulfill the definition of an AE 
or SAE. 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present 
or detected at the start of the study that do not worsen. 
10.5.2. 
Serious Adverse Event 
An SAE is any untoward medical occurrence that at any dose: 
• Results in death 
• Is life-threatening 
− The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in 
which the subject was at risk of death at the time of the event.  It does not refer to 
an event, which hypothetically might have caused death, if it were more severe 
• Requires inpatient hospitalization or prolongation of existing hospitalization 

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− In general, hospitalization signifies that the subject has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for 
observation and/or treatment that would not have been appropriate in the 
physician’s office or outpatient setting.  Complications that occur during 
hospitalization are AEs.  If a complication prolongs hospitalization or fulfills any 
other serious criteria, the event is serious.  When in doubt as to whether 
“hospitalization” occurred or was necessary, the AE should be considered serious. 
− Hospitalization for elective treatment of a pre-existing condition that did not 
worsen from baseline or for administration of anticancer therapy after 
discontinuation of study drug is not considered an AE. 
• Results in persistent or significant disability/incapacity 
− The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
− This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhoea, 
influenza, and accidental trauma (eg, sprained ankle) which may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption. 
• Is a congenital anomaly/birth defect 
• Is an important medical event 
• Medical or scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations such as important medical events that may 
not be immediately life-threatening or result in death or hospitalization but may 
jeopardize the subject or may require medical or surgical intervention to prevent one 
of the other outcomes listed in the above definition.  These events should usually be 
considered serious. 
− Examples of such events include invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, blood 
dyscrasias or convulsions that do not result in hospitalization, or development of 
drug dependency or drug abuse. 
Events Exempted from SAE Reporting 
Serious events that are also efficacy endpoints, including death for OS, will be exempted from 
SAE processing and expedited reporting.32  These events are clinically anticipated events in the 
target treatment population and will be periodically reviewed in an unblinded manner to ensure 
prompt identification of any clinically concerning safety issues. 
10.5.3. 
Grade Assessment 
The severity of AEs will be graded using NCI-CTCAE v5.0.  For each episode, the highest 
severity grade attained should be reported. 
The NCI-CTCAE guidelines do not allow certain grades for certain AEs.  For example, pain can 
be Grade 1 to 3 only (ie, cannot be life-threatening or fatal), whereas sepsis can only be Grade 4 

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or 5 (ie, can only be life-threatening or fatal).  In addition, alopecia can only be Grade 1 or 2.  
The NCI-CTCAE guidelines should be followed closely. 
• Grade 1: Mild AE 
• Grade 2: Moderate AE 
• Grade 3: Severe AE 
• Grade 4: Life-threatening consequences; urgent intervention indicated 
• Grade 5: Death related to AE 
Difference between Severity and Seriousness 
The term “severe” is often used to describe the intensity (severity) of a specific event (as in mild, 
moderate, or severe myocardial infarction); the event itself, however, may be of relatively minor 
medical significance (such as severe headache).  This is not the same as “serious,” which is 
based on subject/event outcome or action criteria usually associated with events that pose a threat 
to a subject’s life or functioning.  Seriousness (not severity) serves as a guide for defining 
regulatory reporting obligations. 
10.5.4. 
Causality Assessment 
The Investigator should assess causal relationship between an AE and the study drug based on 
his/her clinical judgment and the following definitions.  The causality assessment must be made 
based on the available information and can be updated as new information becomes available. 
• Related: 
− The AE follows a reasonable temporal sequence from study drug administration 
and cannot be reasonably explained by the subject’s clinical state or other factors 
(eg, disease under study, concurrent diseases, and concomitant medications). 
− or 
− The AE follows a reasonable temporal sequence from study drug administration 
and is a known reaction to the drug under study (or its chemical group) or is 
predicted by known pharmacology. 
• Not Related: 
− The AE does not follow a reasonable sequence from study drug administration or 
can be reasonably explained by the subject’s clinical state or other factors 
(eg, disease under study, concurrent diseases, and concomitant medications). 
10.5.5. 
Action Taken Regarding Study Drug 
• Dose Not Changed: No change in study drug dosage was made. 
• Drug Withdrawn: The study drug was permanently stopped. 
• Dose Reduced: The dosage of study drug was reduced. 
• Infusion Interrupted: The study drug administration was temporarily stopped. 
• Dose Delayed: The study drug was delayed for 1 or more cycles. 
• Not Applicable: Subject died, study drug completed/permanently discontinued prior 
to reaction/event, or reaction/event occurred prior to start of treatment 
• Unknown: Subject is lost to follow-up 

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10.5.6. 
Other Action Taken for Event 
• None. 
− No treatment was required. 
• Medication required. 
− Prescription and/or over the counter medication was required to treat the AE. 
• Hospitalization or prolongation of hospitalization required. 
− Hospitalization was required or prolonged due to the AE, whether or not 
medication was required. 
• Other. 
10.5.7. 
Adverse Event Outcome 
• Recovered/Resolved 
− The subject fully recovered from the AE with no sequelae observed. 
• Recovered/Resolved with Sequelae 
− The subject fully recovered from the AE but with sequelae. 
• Recovering/Resolving 
− The AE is improving but not recovered 
• Not Recovered/Not Resolved 
− The AE continues without improving. 
• Fatal 
− Fatal should be used when death is a direct outcome of the AE 
• Unknown 
10.6. 
Appendix 7: Key Data Analysis Requirements 
Endpoint/Analysis 
Key Data Requirements 
Primary Analysis 
All eCRF collected data and key external source data (eg, ILD, PK data, 
TROP2 expression data) collected up to the DCO date are required for the 
primary analysis. 
Primary Endpoint - PFS 
All tumor assessment data (eg, target, non-target, new lesion, overall response) 
as assessed by BICR per RECIST v1.1 is required. 
BICR = blinded independent central review DCO = data cutoff; eCRF = electronic Case Report Form; 
ILD = interstitial lung disease; PF = progression-free survival; PK = pharmacokinetic; RECIST v1.1 = Response 
Evaluation Criteria in Solid Tumors version 1.1; TROP2 = trophoblast cell surface protein 2 

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10.7. 
Appendix 8: Instructions Related to Coronavirus Disease 2019 
(COVID-19) 
Due to the potential impact of Coronavirus disease 2019 (COVID-19, due to severe acute 
respiratory syndrome coronavirus 2 [SARS-CoV-2]), on subject safety, the Sponsor recommends 
the following dose modification and management plan for subjects with confirmed or suspected 
COVID-19 while being treated with DS-1062a or docetaxel in this study.  All confirmed or 
suspected COVID-19 infection events must be recorded in the eCRF.  Dose modifications will 
be based on the worst NCI-CTCAE grade.  Use NCI-CTCAE version 5.0 general grading 
criteria to evaluate COVID-19.  All dose modifications (discontinuation, delay, infusion 
interruptions, or reductions) must be recorded on the AE and drug administration eCRFs. 
Dose Modification Criteria for Suspected or Confirmed COVID-19 
If COVID-19 infection is suspected, delay DS-1062a or docetaxel and rule out COVID-19 per 
local guidance. 
• If COVID-19 is ruled out, follow dose modification and management guidance as 
outlined in Table 6.4. 
• If COVID-19 is confirmed or is still suspected after evaluation, follow dose 
modification as outlined in Table 10.7 below and manage COVID-19 per local 
guidance until recovery of COVID-19.  COVID-19 recovery is defined as no 
signs/symptoms of COVID-19, at least 1 negative real-time reverse transcriptase 
polymerase chain reaction (RT-PCR) test result, and nearly or completely resolved 
chest CT findings. 
Table 10.7: 
COVID-19 Dose Modification Criteria 
COVID-19 Worst 
Toxicity NCI-CTCAE 
Version 5.0 Grade 
(unless otherwise 
specified) 
DS-1062a 
Docetaxel 
Grade 1 
Resume study drug at the same dosea 
Follow local institutional 
policy/ practice/regulations 
for the management of 
subjects with COVID-19 
receiving docetaxel. 
Grade 2 
Resume study drug at the same dose if chest 
CT findings are completely resolveda 
Reduce by 1 dose level if chest CT findings 
are nearly resolved 
Grade 3 
Reduce by 1 dose level if chest CT findings 
are completely resolved 
Discontinue study drug if chest CT findings 
are not completely resolved 
Grade 4 
Discontinue study drug 
COVID-19 = Coronavirus disease 2019; CT = computed tomography; NCI-CTCAE = National Cancer Institute - 
Common Terminology Criteria for Adverse Events 
a Closely monitor signs/symptoms after resuming DS-1062a, initially with a phone call every 3 days for the first 
week, and then with a weekly phone call thereafter, for a total of 6 weeks. 

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Additional considerations 
In addition to the recommendations outlined in Table 10.7, Investigators may consider dose 
modifications of the study treatment according to the subject’s condition and after discussion 
with the study medical monitor or designee. 
If an event is suspected to be drug-related ILD/pneumonitis, manage per protocol 
ILD/pneumonitis management guideline (Table 6.4). 
Dosing of DS-1062a or docetaxel may be delayed for up to 9 weeks (63 days) from the planned 
date of the next cycle administration (ie, up to 12 weeks or 84 days from the last infusion).  If a 
subject is assessed as requiring a dose delay longer than 12 weeks or 84 days from the last 
infusion, the subject must discontinue treatment with DS-1062a or docetaxel. 
Before resuming study treatment with DS-1062a or docetaxel, a tumor assessment should be 
performed if the subject’s last scheduled tumor assessment was missed due to COVID-19. 
Prior and Concomitant Medications - Prohibited Therapies/Products 
• Concomitant treatment with chloroquine or hydroxychloroquine is not allowed during 
the study treatment (Section 6.6).  If chloroquine or hydroxychloroquine is 
administered, then a washout period of no less than 14 days is required before 
restarting study treatment. 
COVID-19 Assessment(s) 
All confirmed or suspected COVID-19 infection events must be recorded in the eCRF.  If a 
subject presents to the clinic with symptoms suggestive of COVID-19, but the real-time reverse 
transcription-polymerase chain reaction is not available at the site, a sample kit may be provided 
for sample collection to be tested at a central laboratory.  The results will be provided to the site 
from the central laboratory. 
Serum samples will be used for COVID-19 testing from each subject who provides consent, 
unless prohibited by local restrictions.  Samples will be collected prior to the study drug infusion, 
shipped to a central laboratory, and stored there until the tests become available. 
If subject consents, the remaining serum samples will also be stored for future analysis.  
Unless prohibited by local restrictions, serum and nasopharyngeal swab/saliva sample collection, 
preparation, handling, storage, and shipping instructions are provided in the Study Laboratory 
Manual. 
Statistical Analysis - Assessment of the Impact of COVID-19 
If deemed appropriate, analyses will be performed to explore the impact of COVID-19 on the 
safety, efficacy, and any other endpoints, as appropriate, reported for the study. 
As a result of the impact of COVID-19 on study conduct, adjustments to the statistical analysis 
and interpretation will be made, if required.  These will be described in the SAP. 

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10.8. 
Appendix 9: Patient-reported Outcomes 
10.8.1. 
EORTC-QLQ-C30 
The EORTC-QLQ-C30 is a 30-item questionnaire used in international clinical trials to evaluate 
the quality of life of cancer patients. 
10.8.2. 
EORTC-QLQ-LC13 
The EORTC-QLQ-LC13 is an extension to the EORTC-QLQ-C30 specific to lung cancer. 
Questions 36 and 37 will not be administered to avoid duplication with PRO-CTCAEs 1, 2, and 
3. 
10.8.3. 
EQ-5D-5L 
The EQ-5D-5L is a standardized instrument for measuring generic health status used in 
economic evaluation. 
10.8.4. 
PRO-CTCAE 1-3; 24; 28-29; 51; 74 
Eight items from the PRO-CTCAE will be administered to understand the impact of specific AEs 
on quality of life. 
10.9. 
Appendix 10: Country-specific Protocol Text 
This appendix lists protocol text that applies specifically to Czech Republic (Section 10.9.1) or 
Argentina (Section 10.9.2). 
10.9.1. 
Czech Republic 
The bold text is applicable to the Czech Republic, and strikethrough text is not applicable to 
the Czech Republic. 
Section 5.1, Inclusion Criterion 16: 
Treatment 
Washout Period 
Major surgery 
≥3 weeks 
Radiation therapy including 
palliative radiation to chest 
≥4 weeks  
≥2 weeks (palliative radiation therapy to 
other areas [ie, limited field and 10 or 
fewer days or fractions] including whole 
brain radiotherapy) 
Anticancer chemotherapy 
(Immunotherapy 
[non-antibody-based therapy]), 
retinoid therapy 
≥2 weeks or 5 times the t1/2 of the 
chemotherapeutic agent, whichever is 
longer; ≥6 weeks for nitrosoureas or 
mitomycin C; ≥1 week for tyrosine 
kinase inhibitors approved for the 
treatment of NSCLC-baseline computed 
tomography (CT) scan should be 

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Treatment 
Washout Period 
completed after discontinuation of 
tyrosine kinase inhibitors. 
Antibody-based anticancer 
therapy 
≥4 weeks 
Chloroquine/Hydroxychloroquine >14 days 
Live vaccines 
>30 days 
Section 6.6 Prohibited Therapies/Products 
Live vaccines.  The subject must not be vaccinated with a live vaccine within 30 days 
before, during the Treatment Period, and for 90 days after the last dose of DS-1062a or 
docetaxel. 
Restricted Therapies/Products 
Live vaccines  are not recommended during the study, except for emergency use per 
Investigator’s discretion. 
10.9.2. 
Argentina 
The bold text is applicable to Argentina, and strikethrough text is not applicable to Argentina. 
Section 5.1, Inclusion Criterion #4: 
Has pathologically documented NSCLC: 
• Has Stage IIB, IIIC, or Stage IV NSCLC disease at the time of randomization (based 
on the American Joint Committee on Cancer, Eighth Edition). 
• For inclusion into the study in Argentina, the patient must have has documented 
negative test results for EGFR, ALK, ROS 1, and BRAF genomic alterations.  If test 
results for EGFR, ALK, ROS 1, and BRAF are not available, subjects are required to 
undergo testing performed locally for these genomic alterations. 
• Has no unknown genomic alterations in ROS1, NTRK, BRAF, or other While the 
study is enrolling, if any new actionable driver oncogenes with approved therapies 
(actionable genomic alteration) become available in Argentina, then subject must 
have documented negative test results of such actionable genomic alterations as 
described above. 
 

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11. 
REFERENCES 
1. Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN 
estimates of incidence and mortality worldwide for 36 cancers in 185 countries. 
[published correction appears in: CA Cancer J Clin. 2020;70(4):313] CA Cancer J Clin. 
2018; 68(6):394-424. 
2. Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2019. CA Cancer J Clin. 2019; 69 
(1):7-34.  
3. Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2015, 
based on November 2017 SEER data submission, posted to the SEER website. {Internet]. 
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4. American Cancer Society. Key statistics for lung cancer. [Internet]. Atlanta: American 
Cancer Society; 2020 [cited 2020 Jul 29]. Available from: 
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5. Ricciardi GRR, Russo A, Franchina T, et al. NSCLC and HER2. Between lights and 
shadows. J Thorac Oncol. 2014; 9(12):1750-62.  
6. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Non-Small Cell 
Lung Cancer. Version 6.2020 – June 15, 2020. Plymouth Meeting, PA: National 
Comprehensive Cancer Network, Inc.; 2020. 
7. Gandhi L, Rodriguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus chemotherapy in 
metastatic non-small-cell lung cancer. N Engl J Med. 2018; 378(22):2078-92. 
8. Paz-Ares L, Luft A, Vicente D, et al. Pembrolizumab plus chemotherapy for squamous 
non-small-cell lung cancer. N Engl J Med. 2018; 379(21):2040-51. 
9. Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced 
squamous-cell non-small-cell lung cancer. N Engl J Med. 2015; 373(2):123-35. 
10. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced 
nonsquamous non-small-cell lung cancer. N Engl J Med. 2015; 373(17):1627-39.  
11. Garon EB, Ciuleanu TE, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo 
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randomised phase 3 trial. Lancet. 2014; 384(9944):665-73. 
12. Kobayashi H, Minami Y, Anami Y, et al. Expression of the GA733 gene family and its 
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13. Lin H, Huang JF, Qiu JR, et al. Significantly upregulated TACSTD2 and Cyclin D1 
correlate with poor prognosis of invasive ductal breast cancer. Exp Mol Pathol. 2013; 
94(1):73-8. 
14. Mühlmann G, Spizzo G, Gostner J, et al. TROP2 expression as prognostic marker for 
gastric carcinoma. J Clin Pathol. 2009; 62(2):152-8. 

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15. Jiang A, Gao X, Zhang D, et al. Expression and clinical significance of the Trop-2 gene 
in advanced non- small cell lung carcinoma. Oncol Lett. 2013; 6(2):375-80. 
16. Inamura K, Yokouchi Y, Kobayashi M, et al. Association of tumor TROP2 expression 
with prognosis varies among lung cancer subtypes. Oncotarget. 2017; 8(17):28725-35. 
17. Stepan LP, Trueblood ES, Hale K, et al. Expression of Trop2 cell surface glycoprotein in 
normal and tumor tissues: Potential implications as a cancer therapeutic target. J 
Histochem Cytochem. 2011; 59(7):701-10. 
18. DS-1062a Investigator’s Brochure. Most current version. 
19. Taxotere [package insert].  Bridgewater, NJ: Sanofi-Aventis; 2020. 
20. Planchard D, Popat S, Kerr K, et al. Metastatic non-small cell lung cancer: ESMO 
Clinical Practice Guidelines for diagnosis, treatment and follow-up [published correction 
appears in Ann Oncol. 2019; 30(5):863-70]. Ann Oncol. 2018; 29(Suppl 4):iv192-iv237. 
21. Wu Y-L, Planchard D, Lu S, et al. Pan-Asian adapted Clinical Practice Guidelines for the 
management of patients with metastatic non-small-cell lung cancer: a CSCO-ESMO 
initiative endorsed by JSMO, KSMO, MOS, SSO and TOS. Ann Oncol. 2019; 
30(2):171-210. 
22. U.S. Department of Health and Human Services, Food and Drug Administration, 
Oncology Center of Excellence, Center for Drug Evaluation and Research, Center for 
Biologics Evaluation and Research. Clinical trial endpoints for the approval of NSCLC 
drugs and biologics, Guidance for Industry.  (April 2015).  Available at: 
https://www.fda.gov/media/116860/download 
23. Shepherd FA, Dancey J, Ramlau R, et al. Prospective randomized trial of docetaxel 
versus best supportive care in patients with non-small-cell lung cancer patients previously 
treated with platinum-based chemotherapy. J Clin Oncol. 2000; 18(10):2095-103. 
24. Fosella FV, DeVore R, Kerr RN, et al. Randomized phase III trial of docetaxel versus 
vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously 
treated with platinum-containing chemotherapy. The TAX 320 Non-Small Cell Lung 
Cancer Study Group.  J Clin Oncol. 2000; 18(12):2354-62. 
25. US Food and Drug Administration. Drug development and drug interactions: table of 
substrates, inhibitors and inducers. [cited 03 Mar 2021]. Available at: 
https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-
interactions-table-substrates-inhibitors-and-inducers#classSub. 
26. Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of 
the binomial. Biometrika. 1934; 25(4):404–13. 
27. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. 
Nephron. 1976; 16:31-41. 
28. American Heart Association. Classification of functional capacity and objective 
assessment. Ninth edition, March 14, 1994. {Internet] Dallas: American Heart 
Association: 1994 [cited 02 Sep 2020]. Available from: 
http://my.americanheart.org/professional/StatementsGuidelines/ByPublicationDate/ 

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PreviousYears/Classification-of-Functional-Capacity-and-Objective- 
Assessment_UCM_423811_Article.jsp. 
29. Oken MM, Creech RH, Tormey DC, et al. Toxicity and Response Criteria of the Eastern 
Cooperative Oncology Group. Am J Clin Oncol. 1982; 5(6):649-55. 
30. Heads of Medicines Agencies. Clinical Trial Facilitation Group (CTFG). 
Recommendations related to contraception and pregnancy testing in clinical trials. 
[Internet] Dublin: Heads of Medicines Agencies; 2014 [cited 2020 Sep 20]. 
31. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid 
tumours: Revised RECIST guideline (version 1.1). Euro J Can. 2009: 45(2);228–47. 
32. ICH E2A Guideline. Clinical Safety Data Management: Definitions and Standards for 
Expedited Reporting, Oct 1994. 
33. Garon EB, Johnson ML, Lisberg AE, et al. Efficacy of datopotamab deruxtecan (Dato-
DXd) in patients (pts) with advanced/metastatic (adv/met) non-small cell lung cancer 
(NSCLC) and actionable genomic alterations (AGAs): Preliminary results from the phase 
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Annual Meeting; September 16-21, 2021; Virtual. Abstract LBA49.  

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12. 
LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
18F-FDG 
18F-fluorodeoxyglucose 
5-HT3 
5-hydroxytryptamine 3 antagonists 
α-PD-L1 
anti-programmed cell death ligand 1 
α-PD1 
anti-programmed cell death 1 
AC 
Adjudication Committee 
ADA 
antidrug antibody 
ADC 
antibody-drug conjugate 
AE 
adverse event 
AESI 
adverse event of special interest 
AGA 
actionable genomic alteration(s) 
ALK 
anaplastic lymphoma kinase 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
Anti-HBc 
anti-hepatitis core antibody 
Anti-HBs 
anti-hepatitis B surface antibody 
AST 
aspartate aminotransferase 
AUCinf 
area under the plasma concentration-time curve up to infinity 
AUClast 
area under the plasma concentration-time curve up to the last quantifiable time 
AUCtau 
area under the plasma concentration-time curve during dosing interval 
BCRP 
breast cancer resistance protein 
BI 
before infusion 
BICR 
blinded independent central review 
BOR 
best objective response 
BRAF 
proto-oncogene B-raf 
BSA 
body surface area 
BUN 
blood urea nitrogen 
cfDNA 
cell-free deoxyribonucleic acid 
CHF 
congestive heart failure 
CI 
confidence interval 
CL 
total body clearance 
Cmax 
maximum plasma concentration 
CME 
cystoid macular edema 

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Abbreviation 
Definition 
CNS 
central nervous system 
COVID-19 
Coronavirus disease 2019 
CR 
complete response 
CrCl 
creatinine clearance 
CRO 
contract research organization 
CT 
computed tomography 
CTFG 
Clinical Trial Facilitation Group 
CSR 
clinical study report 
CYP 
cytochrome P450 
Dato-Dxd 
datopotamab deruxtecan 
DCO 
data cutoff 
DCR 
disease control rate 
DMC 
data monitoring committee 
DoR 
duration of response 
DP 
drug product 
EC 
Ethics Committee 
ECG 
electrocardiogram 
ECHO 
echocardiogram 
ECOG PS 
Eastern Cooperative Oncology Group performance status 
eCRF 
electronic Case Report Form 
EDC 
Electronic Data Capture 
EGFR 
epidermal growth factor receptor 
EIU 
Exposure In Utero 
EOI 
end of infusion 
EORTC-QLQ-C30 
The European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire 
EORTC-QLQ-LC13 
The EORTC Quality of Life Questionnaire Lung Cancer-13 
EOS 
End of study 
EOT 
end of treatment 
EQ-5D-5L 
EuroQol Questionnaire-5 dimensions-5 levels 
ER 
exposure-response 
ESMO 
European Society for Medical Oncology 
FAS 
Full Analysis Set 
FU 
follow-up 

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Abbreviation 
Definition 
GCP 
Good Clinical Practice 
G-CSF 
granulocyte-colony stimulating factor 
Hb 
hemoglobin 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
HRT 
hormone replacement therapy 
IA 
interim analysis 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IDMC 
Independent Data Monitoring Committee 
ILD 
interstitial lung disease 
INN 
International Nonproprietary Name 
IRB 
Institutional Review Board 
IRR 
infusion-related reaction 
IRT 
interactive response technology 
IV 
intravenous 
Kel 
elimination rate constant associated with the terminal phase 
LTSFU 
Long-Term Survival Follow-up 
LVEF 
left ventricular ejection fraction 
 
 
MAAA-1162a 
drug linker 
MAAA-1181a 
released drug 
MAAP-9001a 
anti-TROP2 monoclonal antibody 
MATE 
multidrug and toxin extrusion transporter 
MedDRA 
Medical Dictionary for Regulatory Activities 
MET 
mesenchymal-epithelial transition 
MRI 
magnetic resonance imaging 
MRP 
multidrug resistance-associated protein 
msec 
millisecond 
MTD 
maximum tolerated dose 
CCI
CCI

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Abbreviation 
Definition 
MUGA 
multigated acquisition 
NCCN 
National Comprehensive Cancer Network 
NCI - CTCAE 
National Cancer Institute - Common Terminology Criteria for Adverse Events 
NCT 
National Clinical Trial 
NE 
not evaluable/not estimable 
NK-1 
neurokinin-1 
NL 
new lesion 
NSCLC 
non-small cell lung cancer 
NTL 
non-target lesion 
NTRK 
neurotrophic tyrosine receptor kinase 
OATP 
organic anion transporting polypeptide 
OCP 
oral care protocol 
ORR 
overall response rate 
OS 
overall survival 
PD 
progressive disease 
PD-1 
programmed cell death 1 
PD-L1 
programmed cell death ligand 1 
PET 
positron emission tomography 
PFS 
progression-free survival 
PFS2 
second progression-free survival, ie, time from date of randomization to the first 
documented progression on next-line therapy or death due to any cause, whichever 
occurs first 
PK 
pharmacokinetic(s) 
PR 
partial response 
PRO 
patient-reported outcomes 
PRO-CTCAE 
Patient-reported Outcomes version of the Common Terminology Criteria for Adverse 
Events 
PT 
preferred term 
Q3W 
every 3 weeks 
QTcF 
QT interval corrected for heart rate using Fridericia’s formula 
RANKL 
receptor activator of nuclear factor kappa B ligand 
RECIST v1.1 
Response Evaluation Criteria in Solid Tumors version 1.1 
RET 
rearranged during transfection 
ROS1 
ROS proto-oncogene 1 
ROW 
rest of world 

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Abbreviation 
Definition 
RT-PCR 
reverse transcriptase - polymerase chain reaction 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SCLC 
small-cell lung cancer 
SCR 
Screening 
SD 
stable disease 
SmPC 
Summary of Product Characteristics 
SOC 
system organ class 
SoD 
sum of diameters 
SpO2 
peripheral oxygen saturation 
t1/2 
terminal elimination half-life 
TEAE 
treatment-emergent adverse event 
TL 
target lesion 
Tmax 
time to maximum plasma concentration 
TQ 
targeted questionnaire 
TROP2 
trophoblast cell surface protein 2 
TTD 
time to deterioration 
TTR 
time to response 
ULN 
upper limit of normal 
US 
United States 
Vss 
volume of distribution at steady state 
Vz 
volume of distribution based on the terminal phase 
WBC 
white blood cell 
WES 
whole-exome sequencing 
WGS 
whole-genome sequencing