Clinical trial NCT02674568
Conditions: Small Cell Lung Cancer
Keywords: SCLC Small Cell Lung Cancer DLL# Relapsed Refractory
Sponsor: AbbVie
Start date: 2016-01-25; Completion date: 2018-10-19
Enrollment: 342 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the efficacy of rovalpituzumab tesirine as a third-line and later treatment for participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer (SCLC).

Detailed description:

Arms: arm 1: 0.3 mg/kg rovalpituzumab tesirine administered intravenously on Day 1 of each 42-day cycle (every 6 weeks; Q6W) for 2 cycles. An additional 2 cycles of rovalpituzumab tesirine (retreatment) was permitted for eligible participants.
Interventions: intervention 1: Rovalpituzumab tesirine
Intervention descriptions: intervention 1: Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 
CONFIDENTIAL & PROPRIETARY
Statistical Analysis Plan
Product:
Rovalpituzumab tesirine (SC16LD6.5)
Indication:
Small Cell Lung Cancer
Protocol Title:
An Open-label, Single-Arm, Phase 2 Study Evaluating the 
Efficacy, Safety and Pharmacokinetics of Rovalpituzumab 
Tesirine (SC16LD6.5) for Third-line and Later Treatment 
of Subjects with Relapsed or Refractory Delta-Like 
Protein 3-Expressing Small Cell Lung Cancer (TRINITY) 
Protocol Number:
SCRX001-002
Development Phase:
II
Version:
3.0
Prepared by:
/$5
%PDVNFOU%BUF'FCSVBSZ


  Protocol SCRX001-002
Statistical Analysis Plan 
Version 3.0
Confidential & Proprietary
Page 2 of 63
Change of History
Version Number 
Brief description of changes made 
Version 2.0 
Version 2.1 


  Protocol SCRX001-002
Statistical Analysis Plan 
Version 3.0
Confidential & Proprietary
Page 3 of 63
Version 3.0 


  Protocol SCRX001-002
Statistical Analysis Plan 
Version 3.0
Confidential & Proprietary
Page 4 of 63
TABLE OF CONTENTS
Change of History ...........................................................................................................2
TABLE OF CONTENTS ................................................................................................4
ABBREVIATIONS AND ACRONYMS.........................................................................8
1.
BACKGROUND..................................................................................................10
2.
STUDY OBJECTIVES.........................................................................................10
2.1
Primary objective ............................................................................................10
2.2
Secondary objectives.......................................................................................10
2.3
Exploratory objectives.....................................................................................11
3.
STUDY DESIGN.................................................................................................11
3.1
General Description.........................................................................................11
3.2
Determination of Sample Size .........................................................................11
3.3
Methods of Assigning Subjects to Treatment and Stratification .......................12
4.
STUDY ENDPOINTS AND COVARIATES .......................................................12
4.1
Demographic and Baseline Characteristics ......................................................13
4.2
DLL3 Expression ............................................................................................13
4.3
Primary Efficacy Endpoint ..............................................................................14
4.4
Secondary Efficacy Endpoints.........................................................................14
4.5
Safety Endpoints .............................................................................................14


  Protocol SCRX001-002
Statistical Analysis Plan 
Version 3.0
Confidential & Proprietary
Page 5 of 63
4.6
Pharmacokinetic Pharmacodynamic, and Biomarker Endpoints.......................15
5.
ANALYSIS POPULATIONS AND SUBGROUP................................................15
5.1
Analysis Population.........................................................................................15
5.2 
Efficacy Analysis by Line of Therapy .............................................................17
5.3 
Subgroup Analyses for Primary Endpoints ......................................................17
6.
ANALYTIC DEFINITIONS ................................................................................18
7.
STATISTICAL METHODS AND ANALYSIS OF THE INITIAL TREATMENT
.............................................................................................................................20
7.1
Subject Disposition .........................................................................................20
7.2 
Study Conduct.................................................................................................21
7.3 
Demographics, Baseline Characteristics and Prior Therapies...........................21
7.4
Treatment Exposure and Compliance ..............................................................21
7.5
Analysis of Primary Efficacy Endpoint............................................................22
7.5.1
Objective Response Rate ..................................................................22
7.5.2
Overall Survival ...............................................................................23
7.5.3
Sensitivity and Subgroup Analysis....................................................24
7.6
Analysis of Secondary Efficacy Endpoints ......................................................24
7.6.1
Duration of Response .......................................................................24
7.6.2
Clinical Benefit Rate ........................................................................26
7.6.3
Duration of Clinical Benefit..............................................................26


  Protocol SCRX001-002
Statistical Analysis Plan 
Version 3.0
Confidential & Proprietary
Page 6 of 63
7.6.4
Progression-Free Survival.................................................................27
7.6.5. Subgroup Analysis of Secondary Endpoints .................................................29
7.7
Analysis of Safety Endpoints...........................................................................29
7.7.1
Treatment Emergent Adverse Events................................................29
7.7.2
Laboratory Tests...............................................................................31
7.7.3
Vital Signs........................................................................................32
7.7.4
Analyses of ECG Change .................................................................32
7.7.5
Echocardiography.............................................................................33
7.7.6
ECOG Performance Status ...............................................................33
7.7.7
Concomitant Medications.................................................................33
7.8
Analysis of Pharmacokinetic, Pharmacodynamic, and Biomarker Endpoints ...34
8.
INTERIM ANALYSIS.........................................................................................34
9.
VISIT WINDOWS ...............................................................................................35
10.
HANDLING OF MISSING DATA ......................................................................35
A.
STUDY OVERVIEW...........................................................................................35
B.
SCHEDULE OF ASSESSMENTS .......................................................................36
C.
RANDOMIZATION ALGORITHM ....................................................................41
D.
SAS ROUTINES..................................................................................................43
E.
POTENTIALLY CLINICALLY SIGNIFICANT LABORATORY VALUES 
CRITERIA ...........................................................................................................44


  Protocol SCRX001-002
Statistical Analysis Plan 
Version 3.0
Confidential & Proprietary
Page 7 of 63
F.
ADVERSE EVENTS OF SPECIAL .....................................................................46
G.
PLANNED TABLES, FIGURES AND LISTINGS ..............................................50


  Protocol SCRX001-002
Statistical Analysis Plan 
Version 3.0
Confidential & Proprietary
Page 8 of 63
ABBREVIATIONS AND ACRONYMS
Abbreviation
Meaning
ADC
Antibody Drug Conjugate
AE
Adverse Event
ALT
Alanine Transaminase
ANC
Absolute neutrophil count
AST
Aspartate Transaminase
ATA
Anti-Therapeutic Antibodies
AUC
Area Under the Curve
BUN
Blood Urea Nitrogen
CBC
Complete Blood Count
CBR
Clinical Benefit Rate
Cmax
Maximum Plasma Concentration
CNS
Central Nervous System
CR
Complete Response
CRF
Case Report Form
CTCAE
Common Terminology Criteria for Adverse Events
D6.5
Stemcentrx’s drug toxin, a PBD cytotoxic agent
DAR
Drug-to-Antibody Ratio
DLL3
Delta-Like Ligand 3
DOCB
Duration of Clinical Benefit
DOR
Duration of Response
ECG
Electrocardiogram
ECOG
Eastern Cooperative Oncology Group (ECOG)
ESA
Erythropoiesis-Stimulating Agent
FDA
Food and Drug Administration
HR
Heart Rate
ICF
Informed Consent Form
IHC
Immunohistochemistry
IND
Investigational New Drug
IRB
Institutional Review Board
IRC
Independent Radiology Committee (also Central Radiographic 
Assessment Committee)
IC50
Concentration at 50% inhibition
IV
Intravenous
kg
Kilogram
LCNEC
Large Cell Neuroendocrine Carcinoma
KM
Micromolar


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MedDRA
Medical Dictionary for Regulatory Activities
mg
Milligram(s)
Min
Minute(s)
mL
Millilitre(s)
msec
Millisecond
K
Micro
NCI
National Cancer Institute
NSCLC
Non Small Cell Lung Cancer
ORR
Objective Response Rate
PD
Progression Disease
PDc
Pharmacodynamic(s)
PFS
Progression Free Survival
PK
Pharmacokinetic(s)
PR
Partial Response
RP2D
Recommended Phase II Dose
RECIST
Response Evaluation Criteria in Solid Tumors
SAE
Serious Adverse Event
SC16LD6.5
Stemcentrx’s Antibody Drug Conjugate
SCLC
Small Cell Lung Cancer
SCRI
Sarah Cannon Research Institute
SCRX
Stemcentrx
SGOT
Serum Glutamic Oxaloacetic Transaminase
SGPT
Serum Glutamic Pyruvic Transaminase
ULN
Upper Limit of Normal


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1.
BACKGROUND
Rovalpituzumab tesirine (SC16LD6.5) is an antibody-drug conjugate (ADC) consisting 
of a humanized monoclonal antibody against delta-like ligand 3 (DLL3) conjugated to a 
pyrrolobenzodiazepine (PBD) dimer (D6.5) via a serum stable linker. It is constructed 
utilizing a maleimide group for conjugation to the antibody, a PEG linker that serves as a 
spacer, and a serum stable valine-alanine dipeptide, which serves as a cathepsin B 
cleavage site for release of the cytotoxic drug (D6.5).  Upon binding to DLL3, 
SC16LD6.5 internalizes and D6.5 is released via proteolysis of the cathepsin B cleavage 
site.  ADCs theoretically enable the precise delivery of highly potent cytotoxic agents to 
cells expressing the target antigen, thereby combining the best characteristics of 
biologics (target specificity) and chemotherapy (potent killing activity) and improving 
the therapeutic index.
In this document, the statistical methods to be implemented to analyze the data captured 
according to protocol number SCRX001-002, “An Open-label, Single-Arm, Phase 2 
Study Evaluating the Efficacy, Safety and Pharmacokinetics of Rovalpituzumab Tesirine
(SC16LD6.5) for Third-line and Later Treatment of Subjects with Relapsed or 
Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY)” 
Version 4.0 dated 18 Nov 2016 are described.  This trial was registered on 
ClinicalTrials.gov (see https://clinicaltrials.gov/show/NCT02674568).
2.
STUDY OBJECTIVES
The objectives of the study are:
2.1
Primary objective
The primary objective of the study is to investigate the efficacy, as measured by 
objective response rate (ORR) and overall survival (OS), of rovalpituzumab tesirine as 
third-line and later treatment for subjects with relapsed or refractory delta-like protein 3 
(DLL3)-expressing small cell lung cancer (SCLC). 
2.2
Secondary objectives
!
To assess duration of response (DOR), clinical benefit rate (CBR) and 
progression-free survival (PFS) in subjects with relapsed or refractory DLL3-
expressing SCLC treated with rovalpituzumab tesirine


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!
To assess the safety and tolerability of rovalpituzumab tesirine
!
To characterize the pharmacokinetics of rovalpituzumab tesirine and incidence of 
anti-therapeutic antibodies (ATA) 
2.3
Exploratory objectives
!
To explore relationship of DLL3 expression to clinical outcome during treatment 
with rovalpituzumab tesirine
!
To explore the efficacy and safety of rovalpituzumab tesirine retreatment when 
administered to subjects with DLL3-expressing SCLC who previously achieved 
clinical benefit on rovalpituzumab tesirine
!
To explore the effect of rovalpituzumab tesirine on disease biomarkers and 
pharmacodynamics
3.
STUDY DESIGN
3.1
General Description
This is an open-label, single-arm, Phase 2 study of rovalpituzumab tesirine in DLL3-
expressing SCLC subjects with relapsed or refractory disease after receiving at least 2 
previous regimens, including at least one platinum-based regimen. Only subjects with 
tumor cell expression that is DLL3 positive based on an immunohistochemistry (IHC) 
assay specification (Ventana mouse assay, SCRX16.65) will be enrolled in the study.  
3.2
Determination of Sample Size


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3.3
Methods of Assigning Subjects to Treatment and Stratification
SCRX001-002 is a Phase II open-label, single-arm, non-comparative, multicenter study 
of rovalpituzumab tesirine in DLL3-expressing SCLC subjects with relapsed or 
refractory disease after receiving at least 2 previous regimens, including one platinum-
based regimen.  Subjects will be screened and identified as eligible for the study by the 
Investigator at each site. Once screening procedures have been completed for the subject, 
the Registration and Enrollment Form will be completed and submitted to the sponsor or 
designee to confirm eligibility. Eligible subjects will be registered to the study centrally 
by the CRO, PPD.  
No stratification is required.
4.
STUDY ENDPOINTS AND COVARIATES


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4.1
Demographic and Baseline Characteristics
!
Demography includes: Age at baseline (years), sex, ethnicity, race, weight at 
baseline (kg), height (cm) and countries/sites  
!
Baseline Characteristics include: ECOG Performance Status at baseline, history 
of brain metastases, presence of brain metastases at baseline, baseline tumor 
burden, smoking history status and pack years of smoking for previous and 
current smokers, renal function at baseline, and hepatic function at baseline
!
Disease History: stage at initial diagnosis, stage at study entry, history of 
paraneoplastic syndrome, number of metastatic sites, sites of metastatic disease, 
and time from initial diagnosis to first dose (months)
!
Prior therapy information include: 
o
Prior lines of systemic therapy (2, 3, 4 or more)
o
Response to frontline therapy (sensitive, refractory, resistant)
o
Prior systemic therapies drug categories
o
Best overall response of prior systemic therapies
o
Time from diagnosis to the last progression (months)
o
Time to progression on second line (2L) therapy
o
Prior Radiation Therapy (Yes, No) and number of radiation sites (0, 1, 2, 3 
or more)
o
Prior Cancer Surgery (Yes, No) and number of surgeries (0, 1, 2, 3 or 
more)
!
Medical History
4.2
DLL3 Expression
All patients enrolled in the TRINITY study are 
DLL3 positive by 
 


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If multiple scores are available for a subject, then the score with the latest sample date is 
used.  If there are multiple scores available at the latest date then the highest value is 
used. 
4.3
Primary Efficacy Endpoint
This study has two primary endpoints:  
!
Objective response rate (ORR) through the initial treatment period
!
Overall survival (OS)
4.4
Secondary Efficacy Endpoints
!
Best Overall Response of CR or PR Rate
!
Clinical benefit rate (CBR)
!
Duration of Response (DOR)
!
Progression-free Survival (PFS)
4.5
Safety Endpoints
!
Adverse Events
!
Vital signs
!
Laboratory abnormalities
!
Electrocardiographic intervals (e.g. QTc)
!
Echocardiography


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!
Components of a fluid retention questionnaire
The fluid retention questionnaire serves as a tool for patient management on site.  
Data from the questionnaire will not be entered into the EDC and will not be 
analyzed.
4.6
Pharmacokinetic Pharmacodynamic, and Biomarker Endpoints
Pharmacokinetic Endpoints
!
Specific pharmacokinetic parameters of rovalpituzumab tesirine (e.g. Cmax, 
AUC)
!
Anti-therapeutic antibodies against rovalpituzumab tesirine
Pharmacodynamic and Biomarker Endpoints
!
Tumor DLL3 expression
!
Inflammatory Markers
!
Blood Tumor Markers
!
Biomarkers, including soluble DLL3
 
 Analyses of DLL3 
expression and other biomarkers for the purpose of the Clinical Study Report are 
outlined in Section 7.7 of this document.
5.
ANALYSIS POPULATIONS AND SUBGROUP
Analyses of ORR, DOR, CBR, DOCB, and PFS will be performed using response 
assessments by IRC, and by investigators.
5.1
Analysis Population
The modified intent-to-treat (ITT) population includes all subjects who received any 
amount of study drug.  The modified ITT population is the same as the safety analysis 
population. The modified ITT population is the primary analysis population for efficacy, 


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unless otherwise specified, and efficacy analyses will be performed in the following 
analysis sets:
!
All DLL3 High subjects in the modified ITT population 
!
All DLL3 Positive subjects in the modified ITT population
In addition, efficacy analyses will be performed for the modified ITT population 
regardless DLL3 status.
 
The efficacy-evaluable population includes subjects in the modified ITT who had at 
least one post-baseline response assessment, or those that did not have a post-baseline 
response assessment and died within 42 days due to underlying disease progression.  
Analyses based on investigator responses will include subjects meeting the above 
definition based on investigator-assessed post-baseline responses. Similarly, analyses 
based on IRC responses will include subjects meeting the above definition based on IRC-
assessed post-baseline responses. The efficacy-evaluable population may be used in 
supportive analyses of efficacy.  Analyses of ORR and CBR will be also performed in 
the following analysis sets:
!
All DLL3 High subjects in the efficacy-evaluable population
!
All DLL3 Positive subjects in the efficacy-evaluable population
DOR and DOCB would be analyzed in the subsets of patients who achieved CR/PR and 
CR/PR/SD, respectively, in the above analysis sets.
The safety analysis population includes all subjects who receive any amount of study 
drug. A baseline measurement and at least one post-baseline laboratory or other safety-
related measurement obtained after at least 1 dose of study treatment may be required for 
inclusion in the analysis of a specific safety parameter (e.g., lab shifts from baseline).
Pharmacokinetic analysis population consists of all subjects who receive at least 1 
dose of study treatment and at least 1 post-baseline blood sample following a dose of 
study treatment. The pharmacokinetic data will be used in a population PK analysis that 
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Retreatment analysis population consists of all subjects who receive at least 1 dose of 
study drug as retreatment. This population is defined for supplemental analyses. Selected 
efficacy outcomes (e.g., ORR and PFS) for such subjects during retreatment may be 
analyzed separately from the outcomes observed during the initial course of treatment.  
Adverse events reported during retreatment will summarized separately from those 
observed during the initial course of treatment. Time to retreatment will also be 
summarized.
5.2 
Efficacy Analysis by Line of Therapy
Efficacy analyses will include analysis by current line of therapy (3rd line and P3rd line)
in the modified ITT population. Efficacy analyses by current line of therapy (3rd line and 
P3rd line) in the efficacy evaluable population will be included for all endpoints except 
for overall survival.
5.3 
Subgroup Analyses for Primary Endpoints 
The following subgroup analyses will be performed for the primary endpoints of ORR 
and OS for DLL3 high and DLL3 positive subjects in the modified ITT population.
!
Current line of therapy (3rd, 4th, >4th)
o
Determined based on regimen. It will be the last regimen number +1
!
Response to frontline therapy (sensitive, refractory, resistant, and 
resistant/refractory)
!
Prior systemic therapies (drug categories) that may include the following:
o
Topotecan
o
Immunotherapy (Yes, No; includes PD-1 inhibitor and other 
immunotherapy)
!
Prior cancer surgery (Yes, No)
!
Prior radiation therapy (Yes, No)
!
History of brain metastases (Yes, No)
!
Presence of brain metastases at baseline (Yes, No)
!
ECOG at baseline (0, 1, >1)
!
Baseline tumor burden (<Q1, Q1- Q3 inclusive, > Q3; where Q1 and Q3 are the 
quartile values of the baseline sum of the longest diameters of target lesions per 
IRC assessment)
!
Gender (Male, Female)
!
Grouped race (White, Non-White)
!
Age group (<65, P65 years)


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!
U.S. vs non-U.S. sites
In addition to above subgroups, subgroup analysis of OS will also be performed by 
!
Objective response (determined by IRC and investigator assessments) to 
rovalpituzumab tesirine therapy (CR/PR, Non-CR/PR)
!
Best overall response (determined by IRC and investigator assessments) to 
rovalpituzumab tesirine therapy (CR/PR, Non-CR/PR and the subcategories of 
SD, PD, NE/Early Death/Indeterminate)
!
Clinical benefit  (determined by IRC and investigator assessments) to 
rovalpituzumab tesirine therapy  (Yes, No)
!
Time to progression on second line (2L) therapy, defined as time from start of 2L 
therapy to the last progression on 2L therapy (V3 months, > 3 months).
6.
ANALYTIC DEFINITIONS
Initial Treatment Period includes all assessments prior to the retreatment period or the 
start of new anti-cancer therapy, whichever occurs earlier. For subjects who will not be 
retreated, the initial treatment period will include assessments till the start of new anti-
cancer therapy or the end of study, whichever occurs earlier.
Baseline Evaluation is the last available evaluation prior to receiving first dose of study 
drug. This will include any unscheduled evaluation prior to first dose. For subjects 
receiving retreatment, baseline for that period is the last available evaluation prior to 
receiving first dose of study drug for retreatment.
Change from Baseline is defined as the difference between the baseline value as defined 
above and the value at the respective time point.  Negative values represent decreases 
from baseline; positive values will reflect increases from baseline.


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Percent Change from Baseline is defined as the change from baseline divided by the 
baseline value times 100%.  That is
100x (Post-baseline value – baseline value) / (baseline value).
Age at Baseline (in years) is defined from date of birth to date of first dose.
Last Evaluable Disease Assessment, for purpose of censoring, will be the last 
assessment with a response that is determined to be CR, PR, SD, PD, or Not Evaluable 
(NE).
Treatment-Emergent Adverse Event during this period is defined as any adverse event 
occurring on or after initiation of therapy and prior to the earlier of the start of 
retreatment period for those received Rova-T retreatment and the start of a subsequent 
anti-cancer therapy. Any adverse event with onset on or after the first dose of retreatment 
till the start of the next retreatment period or the start of a subsequent anti-cancer therapy 
will be considered treatment-emergent for that retreatment period.
Concomitant Medication is defined as a medication or treatment other than the study 
drug is considered concomitant if it is taken at any time on or after the first dose date.  A 
medication taken prior to first dose date and continuing past first dose date is considered 
concomitant. Concomitant medications that stopped prior to first dose of retreatment will 
only be included in the initial treatment period. Medications started after the first of 
retreatment will be considered concomitant during the retreatment period.
Cumulative Actual Dose (in mg) is the sum of actual dose. Cumulative dose will be 
summarized for both initial treatment period and retreatment period.
Treatment Duration (in cycles) is defined as number of cycles begun where 
rovalpituzumab tesirine dose is greater than zero.
Response to Frontline Therapy (sensitive, refractory, resistant)
!
Refractory: For 1st Regimen if response is ‘PD’ (if first Regimen is ‘NE’ then 
‘NE’)
!
Sensitive: If not Refractory and not ‘NE’ and if (First of Regimen 2 start date –
Last of Regimen 1 End Date, excluding placebo) +1 >= 90 days
!
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      start date – Last of Regimen 1 End Date) +1 < 90 days
o
Note: Impute partial date of start or stop date as follows: If 
month and day both missing for one of the two dates in 
comparison and the year is different, the duration considered >= 
90 days. If the year is the same then response is considered 
‘Undetermined”
o
If only Day is missing then based on the month and year derive 
the months of duration to compare with 3 months duration and 
determine sensitive or resistant
Note: If the response for the first regimen is ‘NE’ then the response to frontline therapy 
for that subject is classified as a ‘Not Evaluable’
Pack Years of Smoking is defined as:
(Number of cigarettes smoked per day/20) * Number of years smoked 
QTcF is defined as:
= / (		)
Tumor Burden is based on the sum of the target lesions at baseline, where baseline is 
defined as the last lesion measurement on or prior to first dose. 
7.
STATISTICAL METHODS AND ANALYSIS OF THE 
INITIAL TREATMENT
Analyses for the initial treatment period (defined in Section 6) will be performed based 
on the modified ITT population as defined in Section 5.1, unless otherwise specified.  
Outputs will display summaries for subjects with DLL3 high and DLL3 positive (per 
Ventana rabbit SP347 IHC assay specification), respectively.
7.1
Subject Disposition
The number and percent of subjects in each analysis population group will be 
summarized. The number and percentage of treated subjects, subjects discontinuing from 
study treatment during initial treatment, including the reasons for study drug 
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reasons for discontinuation from the study, and subjects in the follow-up or retreatment 
period will be presented.  Detailed information will be listed.
7.2 
Study Conduct
Protocol violations and major protocol deviations will be summarized.
7.3 
Demographics, Baseline Characteristics and Prior Therapies
Demographic characteristics including age, sex, race and ethnicity; as well as baseline 
characteristics including height, weight, ECOG performance status, history of brain 
metastases, presence of brain metastases at baseline, and smoking history will be 
summarized and listed.  Summaries of subgroups included in Section 5.3 will also be 
provided.
Disease history data, including stage at initial diagnosis and at study entry, history of 
paraneoplastic syndrome, number of metastatic sites, location of metastatic sites, and 
time from diagnosis to first dose will be summarized and listed.
Medical history being coded with MedDRA will be summarized by system organ class 
and preferred term.  Medical history will be listed as well.
Prior systemic therapy, prior radiation, and prior surgery defined in Section 4.1 will be 
summarized and listed.  
7.4
Treatment Exposure and Compliance
Exposure to study treatment will be summarized and listed:
!
Cumulative actual dose (mg)
!
Treatment duration (cycles)
The number and percent of subjects with at least one dose modification (reduced, 
interrupted or delayed) will be summarized, which will include dose modification due to 
AE and other reasons.  Dose modifications and study treatment discontinuation due to 
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7.5
Analysis of Primary Efficacy Endpoint
All analyses of primary efficacy endpoints will be summarized for the modified ITT and 
efficacy evaluable populations defined in Section 5.
7.5.1
Objective Response Rate
Overall Response at each visit post-baseline is assessed based on a subject’s lesion 
measurements or assessments.  Overall Response is assessed as CR, PR, SD, PD, or NE 
as defined by RECIST version 1.1. An additional category of Early Death will also be 
included which is defined as subjects who died prior to any post-baseline response 
assessment. Amongst all the Overall Responses, the best Overall Response is then 
determined.  The best Overall Response will be ordered as CR, PR, SD, PD, or NE; with 
CR being the best. A subject will be considered to have a best overall response of SD if 
there is a minimum interval of 42 days between the date of assessment and (-7 days to 
allow for scheduled visit window per the protocol) the first dose date. Subjects who died 
prior to the first post-baseline lesion assessment are included in the Early Death 
category. The Not Evaluable (NE) category includes subjects who are not evaluable as 
indicated by the IRC or by the Investigator, in analyses of overall response per IRC and 
investigator, respectively. Subjects who discontinued the study prior to obtaining a post-
baseline scan for lesion assessment will be categorized as Indeterminate.
Objective Response is defined as a subject with the best Overall Response of Complete 
Response (CR) or Partial Response (PR) prior to receiving any subsequent anticancer 
therapy and retreatment, and is confirmed by a consecutive response assessment at least 
4 (28 days) from the initial determination of CR/PR per RECIST v 1.1 as described in 
Table 1:
Table 1 – Confirmed partial and complete response
Overall response 
First time point 
Overall response 
Subsequent time point 
BEST overall response
CR
CR
CR
CR
PR
SD, PD or PRa
CR
SD
SD (if minimum duration for SD met), otherwise, PD
CR
PD
SD (if minimum duration for SD met), otherwise, PD


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CR
NE
SD (if minimum duration for SD met), otherwise, NE
PR
CR
PR
PR
PR
PR
PR
SD
SD
PR
PD
SD (if minimum duration for SD met), otherwise, PD
PR
NE
SD (if minimum duration for SD met), otherwise, NE
NE
NE
NE
Note: In case of SD, measurements must have met the SD criteria at least once after study entry at a minimum 
interval of 42 days (-7 days to allow for scheduled visit window per the protocol).
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.
Only assessments within the initial treatment period will be included if a subject had 
retreatment. ORR is defined as the proportion of subjects with Objective Response.  Best 
Overall Response Rate is defined as the proportion of subjects with a response of CR or 
PR (regardless of confirmation) prior to receive any subsequent anticancer therapy or 
retreatment.
ORR will be presented as a number and percentage with two-sided exact 95% binomial 
confidence interval (CI).  Any subjects not exhibiting a response (CR or PR) as defined 
above are considered non-responders.
Similar analyses as described above will include:
!
Best Overall response of CR or PR determined by the IRC
!
ORR determined by the Investigator
!
Best Overall response of CR or PR determined by the Investigator
7.5.2
Overall Survival
OS is defined as the time in months from the first day of study drug administration (Day 
1) to death.  Subjects who are alive at the end of study will be censored at the date of last 
contact. OS primary analysis includes all follow-up data, including follow-up data in the 
retreatment period or after the start of subsequent anti-cancer therapy. Date of death will 
be obtained from the AE CRF page, or End of Study CRF page, or the Survival Status 
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*Time (month) = (Date of Progression/Death or Censoring – Date of first response (CR or PR) + 1)/ 30.44.  
For Duration of Objective Response, only subjects with a confirmed response of CR or PR will be 
included.
Duration of objective response will be estimated using the Kaplan-Meier method.  The 
median duration of objective response and the corresponding 2-sided 95% confidence 
interval will be produced in addition to the range.  The proportion of responders who 
have not yet experienced disease progression or death  at 6, 9, and 12 months from the 
start date of CR or PR will be summarized descriptively based on Kaplan-Meier 
estimates. The estimates will be accompanied by a two-sided 95% CI.
Duration of best overall response will also be summarized. This analysis will include 
subjects with a response of CR or PR, regardless of confirmation.
Duration of objective response and duration of best overall response will be summarized 
based on IRC assessments, as well as investigator assessments.
7.6.2
Clinical Benefit Rate
Clinical Benefit is defined as the achievement within a subject of a Best Overall 
Response of CR, PR or SD with SD of a minimum duration of 42 days (-7 days to allow 
for scheduled visit window per the protocol) from the first dose date, prior to receiving 
any subsequent anticancer therapy and retreatment; as defined by RECIST version 1.1.  
CBR is defined as the proportion of subjects with clinical benefit.   CBR will be 
presented as a number and percentage with two-sided exact 95% binomial confidence 
interval (CI).  CBR will be summarized based on IRC assessments, and based on 
investigator assessments, respectively.
7.6.3
Duration of Clinical Benefit
DOCB [CR, PR, or SD with SD of a minimum duration of 42 days (-7 days to allow for 
scheduled visit window per the protocol from the first dose date)] is defined as time in 
months from the initial CR, PR, or SD to the time of disease progression or death on 
progression during initial treatment period
disease assessment 
during initial treatment 
period


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study, whichever occurs first during the initial treatment period.  Only subjects with the 
response of CR, PR, or SD are included.
For subjects who are alive and have not experienced disease progression on the study, 
DOCB will be censored at the day of the last tumor assessment during the initial 
treatment period. Censoring rules for duration of clinical benefit will be performed as 
detailed in Table 3 above.  If multiple visits exist, the latest evaluable assessment date 
will be used for censoring except for PD, which will use the earliest assessment date 
when PD was recorded.  Symptomatic deterioration will not be considered PD since a 
lesion assessment will need to be performed to verify disease progression.
DOCB will be estimated using the Kaplan-Meier method.  The median duration of 
clinical benefit and the corresponding 2-sided 95% confidence interval will be produced 
in addition to the range.
Calculation of DOCB will be based on IRC assessments, as well as investigator 
assessments.
7.6.4
Progression-Free Survival
PFS is defined as the time in months from the first day of study drug administration (Day 
1) to disease progression or death on study, whichever occurs first during the initial 
treatment period.
For subjects who are alive and have not experienced disease progression during the 
initial treatment period, PFS will be censored on the day of the last tumor assessment 
during the initial treatment. Subjects with no post-baseline response assessment PFS will 
be censored and have a PFS duration of one day.  Censoring rules for PFS will be 
performed as detailed in Table 4 below.  If multiple dates exist for a given visit, the latest 
evaluable assessment date will be used for censoring except for PD, which will use the 
earliest assessment date when PD was recorded.  Symptomatic deterioration will not be 
considered PD since a lesion assessment will need to be performed to verify disease 
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PFS will be estimated using the Kaplan-Meier method.  The median duration of PFS and 
the corresponding 2-sided 95% confidence interval will be produced in addition to the 
range.
Proportion of subjects alive and without PD at 6, 9 and 12months from the initiation of 
study treatment will be summarized based on Kaplan-Meier estimates, with the 
corresponding 2-sided 95% confidence intervals.
7.6.5. Subgroup Analysis of Secondary Endpoints
Subgroup analyses of secondary endpoints of DOR, CBR, DOCB and PFS may include 
the subgroups described in Section 5.3.  For example, DOR may be analyzed in the DLL3 
subgroups defined in Section 5.3 by current line of therapy (3L vs 3L+), if there are 
sufficient number of responders in each subgroup.  Subgroup analysis of PFS by DLL3 
subgroups will be performed by current line of therapy (3L vs 3L+).
Additional analysis of the secondary endpoints in the modified ITT population, 
regardless of the DLL3 score, will be included. 
 
7.7
Analysis of Safety Endpoints
Unless otherwise stated, all safety analyses will be carried out in the safety analysis 
population by initial treatment period and retreatment period.  No formal statistical 
inference or missing data imputations are planned.
 
 
and for all dosed subjects combined regardless of the DLL3 score.
7.7.1
Treatment Emergent Adverse Events
All adverse events will be coded using the MedDRA dictionary.  Safety analyses will 
involve examination of the incidence, severity, and type of treatment-emergent adverse 
events (TEAE) and serious adverse events as reported by the investigators.  A treatment-
emergent adverse event (TEAE)/treatment emergent serious adverse event is defined in 
Section 6.  An applicable AE/SAE is considered ‘related’ if its relationship to study drug 
was judged by the investigator.  Ongoing adverse events that have a change in severity, 
action taken with study drug, or outcome will be recorded multiple times with the 


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changes. If a subject has multiple occurrences of an adverse event with the same system 
organ class, the most severe event will be chosen. Similarly, if a subject has multiple 
occurrences of an adverse event with the same preferred term, the most severe event will 
be chosen.  If a partial date does not provide enough information to determine the onset 
date relative to first dosing date, then the adverse event will be assumed as treatment-
emergent, otherwise partial dates will be imputed relative to the first dose date.  TEAEs 
will be summarized by system organ class and preferred term.  These summaries will be 
presented by system organ class and preferred term for the following subsets:
!
All TEAEs (All grades, and for maximum grade of 3 or 4)
!
All TESAEs (All grades, and for maximum grade of 3 or 4)
!
All TEAEs leading to study drug discontinuation (All grades, and for maximum 
grade of 3 or 4)
!
All TEAEs leading to death
All drug-related TEAEs, and all drug-related TESAEs will also be summarized.  The 
above tables will also be categorized by gender and age group (<65, P65 years). For 
tables classifying TEAEs by severity, if a subject has multiple occurrences of an adverse 
event with the same system organ class, the most severe event will be chosen. Similarly, 
if a subject has multiple occurrences of an adverse event with the same preferred term, 
the most severe event will be chosen.
Adverse events of special interest (AESI) identified by the specific search criteria 
outlined in Appendix F will be summarized by System Organ Class (SOC) and Preferred 
Term (PT)
 
 
Tabulation of TEAEs will be based on subjects in safety analysis population.  The 
number and percent of subjects with an adverse event will be displayed.  In general, the 
denominator for the percent of subjects with an adverse will be the number of subjects in 
the safety analysis population or the number of subjects in safety analysis population 
within a subgroup if a subgroup is summarized.
All deaths that occur on study will be reported in a subject listing, which will include the 
primary cause of death and the number of days between the date of the last dose of study 
drug and death.


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TEAE that occurred during retreatment period will be summarized separately for those 
who receive retreatment, provided there is sufficient number of subjects who received 
retreatment; otherwise listings will be provided.  Adverse events that occurred after the 
start of subsequent anti-cancer therapy,  if not included in the retreatment period, will be 
summarized separately by system organ class and preferred term, provided there is 
sufficient number of subjects; otherwise listings will be provided.  Adverse events with 
onset prior to first dose date will be considered pre-treatment. All pre-treatment adverse 
events will be summarized by system organ class and preferred term, provided there is  
sufficient number of subjects; otherwise listings will be provided for pre-treatment 
adverse events. Listing of all AEs, SAEs, AEs leading to study drug discontinuation, and 
death will be reported.
7.7.2
Laboratory Tests
Clinical laboratory assessments for this study include: hematology, blood chemistry and 
liver function tests (LFT).  Most hematology, blood chemistry and LFT parameters will 
be graded according to NCI-CTCAE version 4.03, as applicable.  Numeric values will be 
analyzed after conversion into standard international units, where applicable.  A 
complete listing of all laboratory parameters with normal ranges in standard international 
units is included in Appendix 5. Laboratory values with grade 3 or above will be listed. 
For subjects with grade 3 or higher values, all values of that lab test will be listed.
Continuous clinical laboratory results will be summarized by analyte and by visit after 
conversion into standardized SI results. Summary statistics for the change from baseline 
to end-of-treatment (EOT), where end-of-treatment will be summarized using the last 
non-missing post-baseline result no more than 45 days after treatment discontinuation or 
initiation of subsequent therapy (whichever is first, if applicable), will be tabulated.  The 
largest change from baseline (increase or decrease) will be summarized in a shift table 
based on the CTCAE grade which will include both scheduled and unscheduled visits.
Laboratory-based summaries will be provided as follows:
!
Observed, change from baseline, and percent change from baseline at each 
scheduled visit and EOT in parameter results


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!
Shift from baseline to maximum post-baseline CTCAE grade for hematology 
laboratory results
!
Shift from baseline to maximum post-baseline CTCAE grade for chemistry 
laboratory results
!
Elevations in AST, ALT, total bilirubin, and alkaline phosphatase as outlined in 
the FDA Guidance for Industry pertaining to premarketing clinical evaluations for 
drug-induced liver injury (DILI):
o
Elevations of AST, ALT, and either ALT or AST: 3x-, 5x-, 10x-, and 
20xULN 
o
Elevations of bilirubin defined as total bilirubin >2xULN
o
Elevations of alkaline phosphatase >1.5xULN
o
Elevations of ALT or AST (>3xULN) accompanied by elevated total 
bilirubin (>1.5xULN, >2xULN)
In addition, a listing of potential Hy's Law cases (i.e., subjects with AST or ALT 
>3xULN in combination with bilirubin >2xULN) will be also presented.  Results from 
unscheduled or repeated assessments will be included in the DILI evaluations, with 
elevations of AST or ALT in combination with total bilirubin at the same unscheduled or 
repeat assessment.
7.7.3
Vital Signs
Vital signs (weight, pulse rate, systolic blood pressure, diastolic blood pressure, and 
temperature) will be summarized and listed. The summaries include:
!
Observed values
!
Change from baseline by scheduled visit (including mean, median, standard 
deviation, maximum, and minimum)
!
Percentage change from baseline at each scheduled visit through treatment 
discontinuation
7.7.4
Analyses of ECG Change
ECG parameter will be summarized by test and by visit. Summary statistics for the 
change from baseline at end-of-treatment (EOT), where end-of-treatment will be 
summarized using the last non-missing post-baseline result no more than 45 days after 
treatment discontinuation or initiation of subsequent therapy (whichever is first, if 
applicable), will be tabulated. In the case of multiple assessments at a visit, baseline will 


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be the last value prior to dosing.  Observed values, change from baseline, and percent 
change from baseline at each scheduled visit and EOT in parameter results will be 
summarized. One-sided 95% confidence interval for the change from baseline will be 
provided for each visit.
The QTcF triplicate will be summarized and tabulated by maximum QTcF (msec) 
increase from baseline and QTcF (msec) value at any time during treatment:
!
Maximum QTcF (msec) increase from baseline on treatment:
o
QTcF > 10 msec
o
QTcF > 20 msec
o
QTcF > 30 msec
o
QTcF > 60 msec
!
QTcF on treatment: 
o
QTcF > 450 msec
o
QTcF > 480 msec
o
QTcF > 500 msec 
7.7.5
Echocardiography
The presence of pericardial effusion will be summarized using the shift table at each 
scheduled visit. 
7.7.6
ECOG Performance Status
ECOG scores will be summarized using the shift table at each scheduled visit and listed.
Maximum shift of ECOG performance status from baseline will also be summarized.
7.7.7
Concomitant Medications
World Health Organization (WHO) Drug Dictionary will be used for coding medication 
terms.  Medications taken prior to the first dose of study medication through 30 days 
following the last dose of study medication or medications taken after the first dose of 
study medication through 30 days following the last dose of study medication will be 
considered as concomitant medications, which will be listed and summarized (frequency 
and percentage of subjects) by preferred name.  Subjects will be counted once per each 
unique medication.  


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7.8
Analysis of Pharmacokinetic, Pharmacodynamic, and Biomarker 
Endpoints
Pharmacokinetic Endpoints
Rovalpituzumab tesirine ADC concentrations will be listed by patient and summarized 
descriptively (arithmetic mean, standard deviation, minimum, median, maximum).  
Concentrations below the lower limit of quantification of the assay will be treated as 
missing. Results of the population PK analysis, including rovalpituzumab tesirine 
pharmacokinetic parameters (e.g. Cmax, AUC), will be reported separately.
Pharmacodynamic and Biomarker Endpoints
Summary statistics will be generated for tumor expression of DLL3 in dosed subjects.  
Exploratory analyses of other pharmacodynamics and biomarker endpoints (e.g. 
inflammatory markers, blood tumor markers, 
 soluble DLL3) may 
be performed if deemed necessary and appropriate.
8.
INTERIM ANALYSIS
An interim analysis will be conducted when at least one post-baseline response 
assessment from 60 evaluable subjects with DLL3 high expression per IHC assay 
specification are available. Evaluable subjects will be those who have measurable 
disease per central reader with at least one post-baseline response assessment, which can 
include the response assessment performed at the end of treatment study visit. This 
interim analysis will be used to determine if there is sufficient response as described in 
Section 3.1. 
An independent Data Monitoring Committee (iDMC) will be formed to review the 
efficacy and safety data periodically and provide recommendations. Detailed information 
regarding the composition of the iDMC and detailed iDMC procedures will be provided 
in a separate charter maintained by the sponsor and/or designee. The iDMC will review 
the efficacy and safety data periodically and provide recommendations according to the 
charters. The iDMC will review safety data approximately every 6 months. The iDMC 
may request further safety analyses. 


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9.
VISIT WINDOWS
Efficacy analyses based on response assessment will include all scans, including those 
from unscheduled visits.  All data will be tabulated according to scheduled visits, unless 
otherwise specified.  No visit windows will be developed for the safety analysis of this 
study.  Unscheduled visits will be used to determine baseline, the last post-baseline 
value, maximum change from baseline in shift tables, or determination of response.
10.
HANDLING OF MISSING DATA
Standard clinical monitoring and data management practices will be used to ensure the 
integrity of the data.  All start and end dates, where applicable, for study drug exposure, 
safety, efficacy evaluation and study milestones must be complete dates (i.e., day, month 
and year must be present).  Any exceptions will be footnoted on applicable tables, 
figures or listings.  Dates associated with prior medications, prior therapies, and other 
historical data, whether complete or not, that typically are not involved in direct 
calculations affecting safety or efficacy will be listed in the manner of their recording on 
the eCRF.  However, prior medications will be considered as concomitant medications, 
and AE will be considered as treatment-emergent adverse event if the missing date 
makes the categorization undoable.  
A.
STUDY OVERVIEW
The design of the study is described in Section 3.1 of the protocol.


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B.
SCHEDULE OF ASSESSMENTS
Screening
Every Treatment Cycle
EOT1
LTFU
Item
Day
–14 to –1
–1
12
2
3
8
15
22
29
36
E 7 days 
prior to 
next 
dose3
42 days
after last 
dose
q6-12 w
thru 4 yr4
Window
–
–
± 2d2
–
± 1d
± 2d
± 2d
± 2d
± 3d
± 3d
± 3d
± 1w
Location
Clinic Visit
X
X
X
X
X
X
X
Virtual Visit
X
X
X
Investigator (MD) present
X
X
X
X
X
Screening, 
Baseline, and 
Safety 
Assessments
Informed Consent5
X
Demographics
X
Inclusion/Exclusion Criteria
X
Medical and Surgical History6
X
Malignancy History7
X
Prior Anticancer Treatments8
X
Physical examination
X
X
X
X
X
Vital Signs9
X
X
X
X
X
Height
X
Complete Blood Count10
X
X
X
X
X
Chemistries11
X
X
X
X
X
Coagulation Tests12
X
X
X
Urinalysis13
X
X
X
X
X
Hepatitis B and C tests14
X


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Screening
Every Treatment Cycle
EOT1
LTFU
Item
Day
–14 to –1
–1
12
2
3
8
15
22
29
36
E 7 days 
prior to 
next 
dose3
42 days
after last 
dose
q6-12 w
thru 4 yr4
Window
–
–
± 2d2
–
± 1d
± 2d
± 2d
± 2d
± 3d
± 3d
± 3d
± 1w
Pregnancy Test15
X
X
X
Electrocardiogram (ECG)16
X
X
X
X
Echocardiogram17
X
X
Performance Status (ECOG)
X
X
X
Fluid Retention Questionnaire18
X
X
X
X
X
X
X
Daily Weight Diary19
Day 1 predose thru EOT or 30 days after last study treatment, whichever is later
Adverse Events
Procedure-related 
only
Concomitant Therapies20
Treatment
Rovalpituzumab tesirine
X
Dexamethasone
X
X
X
Response 
Assessment
Disease/Response Assessment21
X
X
X22
X23
MRI of the Brain
X
X24
X24
X24
Paraneoplastic Assessment25
X
Screening
Every Treatment Cycle
EOT1
LTFU
Day
–14 to –1
–1
12
2
3
8
15
22
29
36
E 7 days 
prior to 
next 
42 days
after last 
dose
q6-12 w
thru 4 yr4


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Window
–
–
± 2d2
–
± 1d
± 2d
± 2d
± 2d
± 3d
± 3d
dose3
± 3d
± 1w
PK, PD and 
Biomarkers
Pharmacokinetics26
X
X
X
X
X 
Anti-therapeutic antibody
X
X
Tumor Tissue27
X
Inflammatory Markers28
X
X
Blood Tumor Markers29
X
X
Soluble Biomarkers30
X
X
X
X
Serosal Fluid32
Day 1 thru EOT or 30 days after last study treatment, whichever is later


CONFIDENTIAL & PROPRIETARY
Table Notes
1)
EOT occurs 42 ± 3 days after last dose, or within 7 days of documentation of the decision to discontinue treatment, whichever is later. 
2)
Day 1 procedures should be performed prior to dosing of study drug (within 1 day); results from local clinical laboratory tests must be available prior to 
dose; ± 2d window for Cycle 2 Day 1 and beyond
3)
Days 36–42 of each cycle. 
4)
Follow-up occurs every 6 weeks until 6 months, then every 12 weeks. See Section 6.5 of the protocol
5)       Informed consent will be obtained prior to the performance of any study procedures and may occur within 30 days of the Day 1 visit. Screening 
assessments will be completed within 14 days of the Day 1 visit.
6)
Medical and Surgical History includes descriptions of conditions or procedures, and dates of onset - offset.
7)
Malignancy History includes tumor type, stage, sites of metastases, mutational status. 
8)
Prior Anticancer Treatments include names of specific treatments, dates of administration, response to therapy, and duration of response, if known
98)
Vital signs include temperature, blood pressure, pulse, respirations, and weight. 
10)
Complete Blood Count includes white blood cell count with five-part differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), red 
blood cell count, platelet count, hemoglobin, and hematocrit.
11)
Chemistries include electrolytes (sodium, potassium, chloride, and carbon dioxide), creatinine, blood urea nitrogen (BUN), estimated glomerular filtration 
rate, glucose, albumin, total protein, liver function tests (total and direct bilirubin, ALT, AST, alkaline phosphatase, lactate dehydrogenase), amylase, and 
lipase.
12)
Coagulation tests include prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR)
13)
Urinalysis includes dipstick results for color, appearance, specific gravity, pH, glucose, bilirubin, ketones, occult blood, and protein; as well as spot urine 
protein and creatinine.
14)
Hepatitis B and C tests include Hep B surface antigen (HBsAg), Hep B surface antibody (HBsAb), Hep B core antibody (HBcAb) and HCV antibody. 
Results that may be consistent with chronic or active infection must be confirmed by PCR tests for Hep B and/or C.
15)
Pregnancy test consists of blood or urine testing for beta-human chorionic gonadotropin (^-hCG) for women of child-bearing potential. Additional testing 
may be done per the investigator.
16)
Electrocardiogram consists of a 12-lead study taken in triplicate. For Day 3 assessment, evaluate ECGs at approximately the same time of day as on Day 1
- prior to blood sample for pharmacokinetics.
17)
Echocardiogram includes assessment of left ventricular ejection fraction (LVEF) and pericardial effusion.
18)
Fluid Retention Questionnaire includes queries of daily weights and worsening or new edema or dyspnea.
19)
Subjects will maintain a diary of daily weights.
20)
Concomitant Therapies include names of all concomitant medications, blood products, procedures and radiotherapy, including dates of administration, 
dose regimen, route of administration, and purpose.


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21)
Every 6 weeks until 6 months, then every 12 weeks, until disease progression or initiation of new anticancer therapy. Thereafter, Disease/Response 
Assessment consists of subsequent anticancer therapies and dates, date of progression (if not already captured on study), and survival status.
22)
May be omitted if a Disease/Response Assessment was performed within the preceding 6 weeks.
23)
CT imaging of the chest, abdomen, and pelvis, and neck (if indicated), for assessment via RECIST v1.1.
24)
MRI of the brain is only required during treatment when clinically indicated (e.g. if CNS progression is documented)
25)
Paraneoplastic assessment includes documentation of the presence of a SCLC-related paraneoplastic syndrome, if present.
27)
Tumor Tissue consists of procurement for DLL3 testing of archived, representative tumor tissue, or an optional fresh tumor biopsy, if accessible. With 
consent from the subject, tumor tissue may be obtained prior to the screening period and tested for DLL3 expression. Optional: collection of tumor tissue 
at progression to better understand mechanisms of resistance and expression of DLL3.
32)
Serosal Fluid entails procurement, where feasible, of any pericardial, pleural and/or ascitic fluid collected as part of routine care (e.g. as part of a 
therapeutic thoracentesis, pericardiocentsis, or paracentesis), for possible pharmacokinetic, pharmacodynamic and/or biomarker testing.


CONFIDENTIAL & PROPRIETARY
C.
RANDOMIZATION ALGORITHM
Not Applicable


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D.
SAS ROUTINES
Endpoint
Test
SAS Code 
ORR, 
CBR
95% Exact confidence 
interval for the proportion 
calculated using the exact 
binomial method
PFS, 
OS, 
Kaplan-Meier method and 
95% confidence interval for 
median calculated using the 
complementary log-log 
transformation


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E.
POTENTIALLY CLINICALLY SIGNIFICANT 
LABORATORY VALUES CRITERIA
No potentially clinically significant lab values criteria except the ones identified in 
section 7.6.2 were identified.  The following normal ranges were used to identify values 
classified as High or Low.




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F.
ADVERSE EVENTS OF SPECIAL 
Specific treatment-emergent adverse events of special interest (AESI) will be identified 
by the following search criteria:


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Adverse Event of Special Interest
MedDRA Search Criteria / Codes


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G.
PLANNED TABLES, FIGURES AND LISTINGS
Table of Contents
TABLE 14.1__1.1  Disposition
TABLE 14.1__1.2  Analysis Populations
TABLE 14.1__ 1.3  Protocol Deviations
TABLE 14.1__2.1  Demographic Characteristics
TABLE 14.1__ 2.2  Baseline Characteristics
TABLE 14.1__ 2.3.1  Disease History
TABLE 14.1__ 2.3.2  Prior Therapies
TABLE 14.1__ 2.3.3  Medical History by System Organ Class and Preferred Term
TABLE 14.1__ 3.1  Treatment Exposure During Initial Treatment
TABLE 14.1__ 3.2  Dose Modification During Initial Treatment
TABLE 14.2__ 1.1  Best Response During Initial Treatment
TABLE 14.2__ 1.2.1  Best Response During Initial Treatment by Current Line of 
Therapy of 3L and 3L+
TABLE 14.2__ 1.2.2  Best Response During Initial Treatment by Current Line of 
Therapy of 3L and 3L+ and by Onset of Response
TABLE 14.2__ 1.2.3  Best Response During Initial Treatment by Current Line of 
Therapy of 3L and >4L
TABLE 14.2__ 1.3.1  Best Response During Initial Treatment by Response to Frontline 
Therapy of Sensitive, Resistant, and Refractory
TABLE 14.2__ 1.3.2  Best Response During Initial Treatment by Response to Frontline 
Therapy of Sensitive and  Resistant/ Refractory


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TABLE 14.2__ 1.4  Best Response During Initial Treatment by Current Line of Therapy 
of 3L and 3L+
TABLE 14.2__ 1.5  Concordance of Best Overall Response Between Investigator and 
Central Radiology Review Assessment
TABLE 14.2__ 1.6  Concordance of Objective Response Between Investigator and 
Central Radiology Review Assessment
TABLE 14.2__ 2.1  Overall Survival
TABLE 14.2__ 2.2.1  Overall Survival by Current Line of Therapy of 3L and 3L+
TABLE 14.2__ 2.2.2  Overall Survival by Subgroups
TABLE 14.2__ 2.2.3  Overall Survival by Response Subgroups
TABLE 14.2__ 2.2.4  Overall Survival by DLL3 for All Dosed Subjects
TABLE 14.2__ 3.1.1  Duration of Response During Initial Treatment
TABLE 14.2__ 3.1.2  Duration of Response During Initial Treatment by Current Line of 
Therapy of 3L and 3L+
TABLE 14.2__ 3.1.3  Duration of Response During Initial Treatment by Current Line of 
Therapy of 3L and 3L+
TABLE 14.2__ 3.2.1  Duration of Clinical Benefit During Initial Treatment
TABLE 14.2__ 3.2.2  Duration of Clinical Benefit During Initial Treatment by Current 
Line of Therapy of 3L and 3L+
Modified Intent-to-Treat Population 
TABLE 14.2__ 3.2.3  Duration of Clinical Benefit During Initial Treatment by Current 
Line of Therapy of 3L and 3L+
TABLE 14.2__ 3.3.1  Progression-Free Survival During Initial Treatment


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TABLE 14.2__ 3.3.2  Progression-Free Survival During Initial Treatment by Current 
Line of Therapy of 3L and 3L+
Modified Intent-to-Treat Population 
TABLE 14.2__ 3.3.3  Progression-Free Survival During Initial Treatment by Current 
Line of Therapy of 3L and 3L+
TABLE 14.3__ 1.1.1  Summary of Treatment-Emergent Adverse Events During Initial 
Treatment
TABLE 14.3__ 1.1.2  Summary of Treatment-Emergent Drug-Related Adverse Events 
During Initial Treatment
TABLE 14.3__ 1.2.1  Incidence of Treatment-Emergent Adverse Events by System 
Organ Class and Preferred Term During Initial Treatment
TABLE 14.3__ 1.2.2  Incidence of Treatment-Emergent Adverse Events by Preferred 
Term During Initial Treatment
TABLE 14.3__1.2.3  Incidence of Treatment-Emergent Adverse Events by System 
Organ Class,  Preferred Term, and Grade During Initial Treatment
TABLE 14.3__1.3.1  Incidence of Treatment-Emergent Drug-Related Adverse Events by 
System Organ Class and Preferred Term During Initial Treatment
TABLE 14.3__1.3.2  Incidence of Treatment-Emergent Drug-Related Adverse Events by 
System Organ Class,  Preferred Term, and Grade During Initial Treatment


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TABLE 14.3__2.1.1  Incidence of Treatment-Emergent Serious Adverse Events by 
System Organ Class and Preferred Term During Initial Treatment
TABLE 14.3__2.1.2  Incidence of Treatment-Emergent Serious Adverse Events by 
System Organ Class,  Preferred Term, and Grade During Initial Treatment
TABLE 14.3__2.2.1  Incidence of Treatment-Emergent Drug-Related Serious Adverse 
Events by System Organ Class and Preferred Term During Initial Treatment
TABLE 14.3__2.2.2  Incidence of Treatment-Emergent Drug-Related Serious Adverse 
Events by System Organ Class,  Preferred Term, and Grade During Initial Treatment
TABLE 14.3__2.3.1  Incidence of Treatment-Emergent Adverse Events Leading to 
Study Drug Discontinuation by System Organ Class and Preferred Term During Initial 
Treatment
TABLE 14.3__2.3.2 Incidence of Treatment-Emergent Adverse Events Leading to 
Treatment Interruption by System Organ Class and Preferred Term During Initial 
Treatment
TABLE 14.3__ 2.3.3  Incidence of Treatment-Emergent Adverse Events Leading to 
Dose Reduction by System Organ Class and Preferred Term During Initial Treatment
TABLE 14.3__2.3.4  Incidence of Treatment-Emergent Drug-Related Adverse Events 
Leading to Study Drug Discontinuation by System Organ Class and Preferred Term 
During Initial Treatment
TABLE 14.3__2.3.5  Incidence of Treatment-Emergent Drug-Related Serious Adverse 
Events Leading to Study Drug Discontinuation by System Organ Class and Preferred 
Term During Initial Treatment


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TABLE 14.3__2.4.1  Incidence of Treatment-Emergent Adverse Events Leading to 
Death by System Organ Class and Preferred Term During Initial Treatment


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TABLE 14.3__2.8.1  Incidence of Treatment-Emergent Adverse Events by System 
Organ Class,  Preferred Term, and Gender During Initial Treatment
TABLE 14.3__2.8.2  Incidence of Treatment-Emergent Serious Adverse Events by 
System Organ Class, Preferred Term, and Gender During Initial Treatment
TABLE 14.3__2.8.3  Incidence of Treatment-Emergent Drug-Related Adverse Events by 
System Organ Class, Preferred Term, and Gender During Initial Treatment
TABLE 14.3__2.8.4  Incidence of Treatment-Emergent Drug-Related Serious Adverse 
Events by System Organ Class, Preferred Term, and Gender During Initial Treatment
TABLE 14.3__2.8.5  Incidence of Treatment-Emergent Adverse Events Leading to 
Study Drug Discontinuation by System Organ Class, Preferred Term, and Gender During 
Initial Treatment
TABLE 14.3__2.8.6  Incidence of Treatment-Emergent Adverse Events Leading to 
Death by System Organ Class, Preferred Term, and Gender During Initial Treatment
TABLE 14.3__2.9.1  Incidence of Treatment-Emergent Adverse Events by System 
Organ Class,  Preferred Term, and Age Group During Initial Treatment
TABLE 14.3__2.9.2  Incidence of Treatment-Emergent Serious Adverse Events by 
System Organ Class, Preferred Term, and Age Group During Initial Treatment
TABLE 14.3__2.9.3  Incidence of Treatment-Emergent Drug-Related Adverse Events by 
System Organ Class, Preferred Term, and Age Group During Initial Treatment
TABLE 14.3__2.9.4  Incidence of Treatment-Emergent Drug-Related Serious Adverse 
Events by System Organ Class, Preferred Term, and Age Group During Initial Treatment


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TABLE 14.3__2.9.5  Incidence of Treatment-Emergent Adverse Events Leading to 
Study Drug Discontinuation by System Organ Class, Preferred Term, and Age Group 
During Initial Treatment
TABLE 14.3__2.9.6  Incidence of Treatment-Emergent Adverse Events Leading to 
Death by System Organ Class, Preferred Term, and Age Group During Initial Treatment
TABLE 14.4__1.1  Chemistry: Observed and Change from Baseline During Initial 
Treatment
TABLE 14.4__1.2  Chemistry: Shift from Baseline to Maximum Post-Baseline NCI-
CTCAE Grade During Initial Treatment
TABLE 14.4__2.1  Hematology: Observed and Change from Baseline  During Initial 
Treatment
TABLE 14.4__2.2  Hematology: Shift from Baseline to Maximum Post-Baseline NCI-
CTCAE Grade During Initial Treatment
TABLE 14.4__3.1  Coagulation: Observed and Change from Baseline  During Initial 
Treatment
TABLE 14.4__3.2  Coagulation: Shift from Baseline to Maximum Post-Baseline NCI-
CTCAE Grade During Initial Treatment
TABLE 14.4__4.1  Elevated AST, ALT, Total Bilirubin, and Alkaline Phosphatase 
During Initial Treatment
TABLE 14.3__ 5.1  Vital Signs During Initial Treatment
TABLE 14.3__5.2  Electrocardiogram During Initial Treatment
TABLE 14.3__6.1 Electrocardiogram: Summary of QTcF1 Interval During Initial 
Treatment
TABLE 14.3__7.1 Echocardiography: Pericardial Effusion During Initial Treatment
TABLE 14.3__8.1  ECOG Score: Shift from Baseline to Maximum Post-Baseline Value 
During Initial Treatment


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TABLE 14.3__9.1  Concomitant Medications During Initial Treatment
TABLE 14.3__9.1.1  Serum Concentrations of ADC, Tab, D6.5, and SC16
TABLE 14.3__9.1.2  Serum Concentrations of ADC, Tab, D6.5, and SC16
FIGURE 14.2__ 1.1.1  Overall Survival
FIGURE 14.2__ 1.1.2  Overall Survival by DLL3 Score
FIGURE 14.2__ 1.2.1  Duration of Response
FIGURE 14.2__ 1.2.2  Duration of Response by DLL3 Score
FIGURE 14.2__ 1.3.1 Progression-Free Survival
FIGURE 14.2__ 1.3.2  Progression-Free Survival by DLL3 Score
FIGURE 14.2__ 2.1.1  Objective Response Rate by Central Radiology Review and by 
Subgroup (All Dosed Subjects)
FIGURE 14.2__ 2.1.2  Objective Response Rate by Central Radiology Review and by 
Subgroup (DLL3 High)
FIGURE 14.2__ 2.1.3  Objective Response Rate by Central Radiology Review and by 
Subgroup (DLL3 Positive)
FIGURE 14.2__ 2.1.4  Objective Response Rate by Central Radiology Review and by 
DLL3 (All Dosed Subjects)
FIGURE 14.2__ 2.2.1  Objective Response Rate by Investigator and by Subgroup (All 
Dosed Subjects)
FIGURE 14.2__ 2.2.2  Objective Response Rate by Investigator and by Subgroup (DLL3 
High)
FIGURE 14.2__ 2.2.3  Objective Response Rate by Investigator and by Subgroup (DLL3 
Positive)


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FIGURE 14.2__ 2.2.4  Objective Response Rate by Investigator and by DLL3 (All 
Dosed Subjects)
FIGURE 14.2__ 2.3.1  Overall Response Rate by Central Radiology Review and by 
Subgroup (All Dosed Subjects)
FIGURE 14.2__ 2.3.2  Overall Response Rate by Central Radiology Review and by 
Subgroup (DLL3 High)
FIGURE 14.2__ 2.3.3  Overall Response Rate by Central Radiology Review and by 
Subgroup (DLL3 Positive)
FIGURE 14.2__ 2.4.1  Overall Response Rate by Investigator and by Subgroup (All 
Dosed Subjects)
FIGURE 14.2__ 2.4.2  Overall Response Rate by Investigator and by Subgroup (DLL3 
High)
FIGURE 14.2__ 2.4.3  Overall Response Rate by Investigator and by Subgroup (DLL3 
Positive)
FIGURE 14.2__ 2.5.1  Overall Survival by Subgroup
FIGURE 14.2__ 3.1  Maximum Percent Change in Target Lesion Measurement from 
Baseline for DLL3 High 3L per Investigator
FIGURE 14.2__ 3.2  Maximum Percent Change in Target Lesion Measurement from 
Baseline for DLL3 High 3L per Central Radiology Review
FIGURE 14.2__ 4.1  Percent Change in Target Lesion Measurement from Baseline for 
DLL3 High 3L with Best Overall Response of CR or PR per Investigator
FIGURE 14.2__ 4.2  Percent Change in Target Lesion Measurement from Baseline for 
DLL3 High 3L with Best Overall Response of CR or PR per Central Radiology Review
APPENDIX 16.2__1.1  Disposition
APPENDIX 16.2__1.2  Enrollment


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APPENDIX 16.2__1.3  Deaths
APPENDIX 16.2__2.1  Protocol Deviations
APPENDIX 16.2__3.1  Demography
APPENDIX 16.2__3.1.1  Demography of Subjects in Retreatment 1
APPENDIX 16.2__3.1.2  Demography of Subjects in Retreatment 2
APPENDIX 16.2__4.1 Malignancy History and Paraneoplastic Symptoms
APPENDIX 16.2__4.2 Medical History
APPENDIX 16.2__4.3 Prior Cancer Therapy
APPENDIX 16.2__4.4 Prior Cancer Radiation Therapy
APPENDIX 16.2__4.5 Surgeries and Procedures
APPENDIX 16.2__5.1 Study Treatment During Initial Treatment
APPENDIX 16.2__6.1.1 Target, Non-Target, and New Lesions by Investigator During 
Initial Treatment
APPENDIX 16.2__6.1.2 Target, Non-Target, and New Lesions by IRC During Initial 
Treatment
APPENDIX 16.2__6.1.2.1 Target, Non-Target, and New Lesions by IRC for Subjects in 
Retreatment 1
APPENDIX 16.2__6.1.2.2 Target, Non-Target, and New Lesions by IRC for Subjects in 
Retreatment 2
APPENDIX 16.2__6.2.1 Response Assessment by Investigator
APPENDIX 16.2__6.2.2 Response Assessment by IRC
APPENDIX 16.2__6.2.1.1 Response Assessment by Investigator for Subjects in 
Retreatment 1


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APPENDIX 16.2__6.2.2.1 Response Assessment by IRC for Subjects in Retreatment 1
APPENDIX 16.2__6.2.1.2 Response Assessment by Investigator for Subjects in 
Retreatment 2
APPENDIX 16.2__6.2.2.2 Response Assessment by IRC for Subjects in Retreatment 2
APPENDIX 16.2__6.3 Objective Response and Clinical Benefit During Initial Treatment
APPENDIX 16.2__6.4 Time to Event and Key Subgroups
APPENDIX 16.2__7.1  Treatment-Emergent Adverse Events
APPENDIX 16.2__ 7.2  Treatment-Emergent Serious Adverse Events
APPENDIX 16.2__7.3  Treatment-Emergent Adverse Events Leading to Study Drug 
Withdrawal
APPENDIX 16.2__7.4  Fatal Treatment-Emergent Adverse Events
APPENDIX 16.2__7.5  Pre-Treatment or Post-Treatment  Adverse Events
APPENDIX 16.2
7.6  Treatment  Emergent Adverse Events of Subjects in Retreatment 1
APPENDIX 16.2__7.7  Treatment  Emergent Adverse Events of Subjects in Retreatment 
2
APPENDIX 16.2__8.1  Potential Hy’s Law Cases During Initial Treatment
APPENDIX 16.2__8.2.1  Laboratory Results: Hematology
APPENDIX 16.2__8.2.2  Laboratory Results with CTCAE Grade 3 or Higher: 
Hematology
APPENDIX 16.2__8.3.1  Laboratory Results: Chemistry
APPENDIX 16.2__8.3.2  Laboratory Results with CTCAE Grade 3 or Higher: 
Chemistry
APPENDIX 16.2__8.4  Laboratory Results: Urinalysis


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APPENDIX 16.2__8.5.1  Total Ab, ADC, and SC-DR002 Concentration
APPENDIX 16.2__8.6.1  Vital Signs
APPENDIX 16.2__8.6.2.1  Electrocardiogram
APPENDIX 16.2__8.6.2.2  Electrocardiogram: QTcF
APPENDIX 16.2__8.6.3  ECOG Performance Status
APPENDIX 16.2__8.6.4  Echocardiogram
APPENDIX 16.2__ 8.7.1  Concomitant Medications: General
APPENDIX 16.2__ 8.7.2  Concomitant Medications: Steroid
APPENDIX 16.2__ 8.7.3  Concomitant Medications Due to Adverse Events
APPENDIX 16.2__ 8.7.4  Subsequent Anti-Cancer Treatment
APPENDIX 16.2__ 8.7.5  Survival Status