Clinical trial NCT03098030
Conditions: Small Cell Lung Cancer
Keywords: Dinutuximab Irinotecan Topotecan
Sponsor: United Therapeutics
Start date: 2017-06-01; Completion date: 2020-03-26
Enrollment: 483 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period \<3 months or ≥3 months).

Detailed description:

Arms: arm 1: Dinutuximab (10 mg/m\^2 IV) + Irinotecan (350 mg/m\^2 IV) on Day 1 of every 21 days (q21d). Dinutuximab dose will be escalated in 2 mg/m\^2 increments per cycle if maximal pain is \<Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m\^2 IV. arm 2: Irinotecan (350 mg/m\^2 IV) on Day 1 of each q21d cycle. arm 3: Dinutuximab (16 mg/m\^2 IV) + Irinotecan (350 mg/m\^2 IV) on Day 1 of each q21d cycle. Dinutuximab dose will be escalated in 2 mg/m\^2 increments per cycle if maximal pain is \<Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m\^2 IV. arm 4: Topotecan (1.5 mg/m\^2 IV) on Days 1 to 5 of each q21d cycle.
Interventions: intervention 1: Dinutuximab intervention 2: Irinotecan intervention 3: Topotecan
Intervention descriptions: intervention 1: Dinutuximab injection, for intravenous (IV) use intervention 2: Irinotecan injection, IV infusion intervention 3: Topotecan for injection

Protocol documents:
Prot_001.pdf: 
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SAP_000.pdf: 
United Therapeutics Corporation 
Protocol: DIV-SCLC-301 
21 December 2019 
 
 
STATISTICAL ANALYSIS PLAN 
 
A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan  
versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory  
Small Cell Lung Cancer 
 
Protocol Number: DIV-SCLC-301 
 
US IND Number: 133,047 
 
 
Date:  
Final 21 December 2019 
 
 
 
 
Confidentiality Statement 
The information in this document contains trade secrets and commercial information that is privileged or confidential and 
may not be disclosed, unless disclosure is required by applicable laws and regulations.  In any event, persons to whom the 
information is disclosed must be informed that the information is privileged or confidential and may not be further disclosed 
by them.  These restrictions on disclosure will apply equally to all future information supplied to you indicated as privileged 
or confidential. 
 
 


'RFX6LJQ(QYHORSH,'$'(('%%')&%$)%


United Therapeutics Corporation 
Protocol: DIV-SCLC-301 
21 December 2019 
 
CONFIDENTIAL 
3 
Table of Contents 
STATISTICAL ANALYSIS PLAN APPROVAL PAGE .................................................... 2 
Table of Contents ..................................................................................................................... 3 
List of Abbreviations ............................................................................................................... 6 
1 
Introduction ................................................................................................................... 8 
2 
Objectives ...................................................................................................................... 8 
2.1 
Primary Objective ........................................................................................................ 8 
2.2 
Secondary Objectives .................................................................................................. 8 
2.3 
Exploratory Objectives ................................................................................................ 9 
3 
Overall Study Design and Treatment Plan ................................................................. 9 
3.1 
Changes in the conduct of the study or planned analyses ......................................... 11 
4 
Statistical Methodology .............................................................................................. 11 
4.1 
General Statistical Considerations ............................................................................. 11 
4.2 
Determination of Sample Size ................................................................................... 11 
4.3 
Analysis Data Sets ..................................................................................................... 12 
4.4 
Disposition of Subjects .............................................................................................. 13 
4.5 
Protocol Deviations and Violations ........................................................................... 13 
4.6 
Demographic and Other Baseline Characteristics ..................................................... 13 
4.6.1 
Medical and Surgical History ................................................................................ 14 
4.7 
Prior/Concomitant Treatment .................................................................................... 14 
4.7.1 
Prior Cancer Therapy ............................................................................................. 14 
4.7.2 
Concomitant Treatments ........................................................................................ 15 
4.8 
Study Drug Exposure ................................................................................................ 15 
4.8.1 
Exposure ................................................................................................................ 15 
4.9 
Efficacy Analysis ....................................................................................................... 16 
4.9.1 
Overall Survival (OS) ............................................................................................ 16 
4.9.2 
Progression-Free Survival (PFS) ........................................................................... 18 
4.9.3 
Overall Response Rate (ORR) ............................................................................... 18 
4.9.4 
Clinical Benefit Rate (CBR) .................................................................................. 18 


United Therapeutics Corporation 
Protocol: DIV-SCLC-301 
21 December 2019 
 
CONFIDENTIAL 
4 
4.9.5 
Other Efficacy Outcomes ....................................................................................... 19 
4.9.6 
Subgroup Analysis ................................................................................................. 20 
4.10 
Safety Analysis .......................................................................................................... 20 
4.10.1 
Adverse Events – Part 1 ......................................................................................... 20 
4.10.2 
Adverse Events – Part 2 ......................................................................................... 20 
4.10.3 
Pain Medications and Infusion Related Reaction Medications ............................. 22 
4.10.4 
Clinical Laboratory Parameters ............................................................................. 23 
4.10.5 
Vital Signs .............................................................................................................. 23 
4.10.6 
Physical Examinations ........................................................................................... 23 
4.10.7 
ECOG Performance Status .................................................................................... 24 
5 
Interim Data Monitoring ............................................................................................ 25 
6 
References .................................................................................................................... 26 
7 
Programming Considerations .................................................................................... 27 
7.1 
Table, Listing, and Figure Format ............................................................................. 27 
7.1.1 
General ................................................................................................................... 27 
7.1.2 
Headers .................................................................................................................. 27 
7.1.3 
Display Titles ......................................................................................................... 28 
7.1.4 
Column Headers..................................................................................................... 28 
7.1.5 
Body of the Data Display ....................................................................................... 29 
7.1.6 
Footnotes ................................................................................................................ 30 
7.2 
Data-Handling Rules ................................................................................................. 31 
7.2.1 
Unit Conversion to Months .................................................................................... 31 
7.2.2 
Visits ...................................................................................................................... 31 
7.2.3 
Demographics and Baseline Characteristics .......................................................... 31 
7.2.4 
Prior and Concomitant Medications ...................................................................... 32 
7.2.5 
Safety ..................................................................................................................... 33 
7.2.6 
SAS® Procedures ................................................................................................... 33 
8 
List of Tables, Listings, and Figures ......................................................................... 35 
8.1 
LIST OF TABLES .................................................................................................... 35 


United Therapeutics Corporation 
Protocol: DIV-SCLC-301 
21 December 2019 
 
CONFIDENTIAL 
5 
8.2 
LIST OF LISTINGS .................................................................................................. 38 
8.3 
LIST OF FIGURES ................................................................................................... 40 
 


United Therapeutics Corporation 
Protocol: DIV-SCLC-301 
21 December 2019 
 
CONFIDENTIAL 
6 
List of Abbreviations 
Abbreviation or Acronym 
Definition 
ADA 
anti-drug antibodies 
AE 
adverse event 
ATC 
anatomical therapeutic chemical 
BMI 
body mass index 
BOR 
best overall response 
BSA 
Body surface area 
CBR 
clinical benefit rate 
CP 
conditional power 
CR 
complete response 
CSR 
clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events  
DMC 
Data Monitoring Committee 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group  
eCRF 
electronic case report form 
EDC 
electronic data capture 
EOT 
end of treatment 
ICF 
informed consent form 
ICH 
International Conference on Harmonization 
ITT 
Intention-to-Treat 
MedDRA 
Medical Dictionary for Regulatory Activities 
mITT 
Modified Intention-to-Treat 
NAb 
neutralizing antibodies 
ORR 
objective response rate 
OS 
overall survival 
PD 
progressive disease 
PFS 
progression-free survival 
PK 
pharmacokinetics 
PR 
partial response 


United Therapeutics Corporation 
Protocol: DIV-SCLC-301 
21 December 2019 
 
CONFIDENTIAL 
7 
Abbreviation or Acronym 
Definition 
PT 
preferred term 
RECIST 
Response Evaluation Criteria in Solid Tumors  
ROW 
rest of world 
RPIC 
randomization and product inventory control 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SCLC 
small cell lung cancer 
SD 
stable disease 
SOC 
System Organ Class 
SRC 
safety review committee 
TEAE 
treatment-emergent adverse event 
WHO 
World Health Organization  
 


United Therapeutics Corporation 
Protocol: DIV-SCLC-301 
21 December 2019 
 
CONFIDENTIAL 
8 
1 
INTRODUCTION 
This Statistical Analysis Plan (SAP) was developed after review of United Therapeutic 
Corporation (UTC) Study Protocol DIV-SCLC-301 (Amendment 2, dated 19-December-2017) 
and the associated electronic case report form (eCRF).  The SAP contains definitions of 
analysis sets, derived variables, and statistical methods to be used for the analysis and reporting 
of all efficacy and safety data collected for these subjects. The statistical considerations in this 
SAP supersede those identified in the protocol; where considerations are substantially different, 
they will be identified as such in this document.  Protocol amendment(s), if required, will not 
necessitate an amendment to the SAP unless they have an impact on the statistical analysis 
methodology. This SAP was developed and finalized prior to any unblinding of the clinical 
database for Protocol DIV-SCLC-301. Exploratory analyses of pharmacokinetics (PK), 
immunogenicity, and pharmacodynamics data will be covered by separate analysis plans. If 
additional analyses are required to supplement the planned analyses described in this SAP, they 
may be performed and will be identified in the Clinical Study Report (CSR).   
The SAP was written in accordance with recommendations outlined in the International 
Conference on Harmonisation (ICH) E91 Guideline entitled “Guidance for Industry: Statistical 
Principles for Clinical Trials” and the most recent ICH E32 Guideline, entitled “Guidance for 
Industry: Structure and Content of Clinical Study Reports.” 
2 
OBJECTIVES 
2.1 
Primary Objective 
The primary objective of this study is to compare overall survival (OS) in subjects treated with 
dinutuximab and irinotecan versus subjects treated with irinotecan alone as a second-line 
treatment for relapsed or refractory small cell lung cancer (SCLC). 
2.2 
Secondary Objectives 
The secondary objectives of the study are: 
x To compare progression-free survival (PFS), objective response rate (ORR) (complete 
response [CR] + partial response [PR]) and clinical benefit rate (CR + PR + stable 
disease [SD]) in subjects treated with dinutuximab and irinotecan versus subjects 
treated with irinotecan alone. 
x To compare the safety of subjects treated with dinutuximab and irinotecan versus 
subjects treated with irinotecan alone. 


United Therapeutics Corporation 
Protocol: DIV-SCLC-301 
21 December 2019 
 
CONFIDENTIAL 
9 
x To evaluate the pharmacokinetics of subjects treated with dinutuximab. 
x To compare OS, PFS, ORR, and clinical benefit rate (CBR) in subjects treated with 
dinutuximab and irinotecan versus subjects treated with topotecan alone. 
2.3 
Exploratory Objectives 
The exploratory objective of the study is to assess the relationship between selected biomarkers 
and survival of subjects treated with dinutuximab. 
3 
OVERALL STUDY DESIGN AND TREATMENT PLAN 
This study is an open-label randomized Phase II/III study of dinutuximab and irinotecan 
compared to irinotecan alone with an intrasubject dose-escalation lead-in phase in subjects with 
relapsed or refractory SCLC. 
At the time of Amendment 2, the lead-in phase of the study (referred to as Part 1) had enrolled 
12 subjects with SCLC, meeting the enrollment target of approximately 10 subjects.  In Part 1,  
dinutuximab is being administered at increasing doses, as tolerated, together with irinotecan at 
a dose of 350 mg/m2 IV on Day 1 of each 21-day cycle.  Subjects receive dinutuximab at a 
starting dose of 10 mg/m2 IV, with increases administered in 2 mg/m2 increments per cycle in 
subsequent cycles if maximal pain with the prior dose LV*UDGHRU*UDGHthat in the view 
of the Investigator is adequately managed and the drug is otherwise tolerated.  The maximum 
dose of dinutuximab that may be administered is 17.5 mg/m2 (If this dose is reached, the last 
dose increment would be 1.5 mg/m2).  Dinutuximab dose is to be decreased in 2 mg/m2 
decrements per cycle depending on the toxicity observed to as low as 8 mg/m2.  If a dose 
decrease from 17.5 mg/m2 is required, the initial dose reduction should be 1.5 mg/m2 (and 
2 mg/m2 for any subsequent decrements).  Subjects enrolled in Part 1 will remain on study 
treatment until objective disease progression or intolerance. 
The study safety review committee (SRC) met after 12 subjects in Part 1 were exposed to 
irinotecan and dinutuximab for a mean of 3.2 cycles and initially recommended opening Part 2 
at a starting dose of dinutuximab of 14 mg/m2/day.  At the next meeting, the SRC reviewed 
additional safety data (after 8 of 12 subjects in Part 1 had received 16 mg/m2/day) and voted to increase 
the starting dose to 16 mg/m2/day.   
In Part 2, approximately 460 additional subjects with relapsed or refractory SCLC will be 
randomized in a 2:2:1 allocation ratio (184/irinotecan group, 184/dinutuximab combination 
group and 92/topotecan group) to one of three groups as specified below.  Randomization will 


United Therapeutics Corporation 
Protocol: DIV-SCLC-301 
21 December 2019 
 
CONFIDENTIAL 
10 
be stratified by the subject’s response to prior platinum therapy (relapse-free period < 3 months 
oU   months).  Randomization will be performed using a web-based randomization and 
product inventory control (RPIC) system provided by a third-party vendor.  Specific procedures 
for randomization through RPIC are contained in the study procedures manual. 
x Group A: Irinotecan; or 
x Group B: Dinutuximab + Irinotecan; or 
x Group C: Topotecan. 
Subjects randomized to Group A or Group B will receive irinotecan at a dose of 350 mg/m2 on 
Day 1 of each cycle. 
Subjects randomized to Group B will also receive dinutuximab on Day 1 of each cycle 
beginning with a starting dose of 16 mg/m2 IV.  Dose escalation and de-escalation for 
dinutuximab will occur as in Part 1.  The maximum dose of dinutuximab that may be 
administered is 17.5 mg/m2.  If this dose is reached, the last dose increment would be 
1.5 mg/m2. 
Subjects randomized to Group C will receive topotecan 1.5 mg/m2 IV for the first 5 consecutive 
days of each 21-day cycle.  
There is a 2-day window around administration of study drugs on Day 1 of each cycle except 
for the first cycle (initial treatment should begin within 3 working days of enrollment or 
randomization).  All subjects (Part 1 and Part 2) will be treated until disease progression or 
intolerance.  All subjects will be followed for disease progression even those discontinuing 
study drug for other reasons (e.g., intolerance). 
An end of treatment (EOT) visit will occur approximately 30 days after the last administration 
of all study drugs (dinutuximab and/or chemotherapy) or prior to the initiation of subsequent 
treatment (whichever occurs first). 
For subjects receiving dinutuximab, immunogenicity follow-up will continue for up to 16 
weeks following the last dose of dinutuximab to assess anti-drug antibodies (ADA) and 
neutralizing antibodies (NAb). 
Follow-up for survival will continue until the subject has withdrawn consent, is lost to follow-
up, has died, or until the Sponsor makes a decision to close the study.  It is important that all 
subjects are followed for survival.  No crossover is allowed given OS is the primary endpoint. 


United Therapeutics Corporation 
Protocol: DIV-SCLC-301 
21 December 2019 
 
CONFIDENTIAL 
11 
3.1 
Changes in the conduct of the study or planned analyses 
Not applicable. 
4 
STATISTICAL METHODOLOGY 
4.1 
General Statistical Considerations 
Data from subjects enrolled in Part 1 will primarily be displayed in listing format and simple 
statistics summaries.  Part 2 data will be summarized in tables according to the treatment 
groups: Dinutuximab + Irinotecan, Irinotecan, and Topotecan. Unless otherwise specified, 
Part 1 data will be summarized in the same table as Part 2, but will not be included in any 
inferential analyses.   
Descriptive statistics (n, mean, standard deviation [Std Dev], median, minimum [min], and 
maximum [max]) for continuous variables, and frequency distributions and percentages for 
discrete variables will be utilized.  In general, the baseline measurement for Part 1 subjects is 
defined as the last measurement collected prior to the first dose of study treatment.  For Part 2 
subjects, baseline is defined as the last measurement obtained prior to the date of 
randomization.   
All tabulations of summary statistics, graphical presentations, and statistical analyses will be 
performed using SAS® Version 9.4 or higher. 
4.2 
Determination of Sample Size 
The sample size for Part 1 (approximately 10 subjects) was not based on statistical power 
calculations.  It is considered adequate from a clinical perspective to judge the safety of the 
combination of dinutuximab and irinotecan, two approved products with known and distinct 
toxicities.   
Power calculations for the randomized portion of the study (Part 2) were based on the primary 
efficacy objective: to demonstrate significantly longer OS with combination therapy 
(dinutuximab + irinotecan) vs. irinotecan alone.  A 2:2:1 randomization scheme was chosen to 
increase exposure to dinutuximab and to maximize statistical power for the primary efficacy 
comparison (dinutuximab combination vs. irinotecan).  A total 306 deaths in these two groups 
will provide approximately 80% power to detect a HR of 0.725 or a 2.3 month gain in median 
OS (from 6 to 8.3 months); this calculation is based on a log-rank test (2-sided alpha=0.05).  If 
at least 82 deaths occur in the topotecan group, the power will be approximately 65% to detect 


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the same hazard ratio of 0.725, or a 2.3-month gain in median OS (6 to 8.3 months) with the 
combination versus topotecan alone (a secondary objective).  Overall, a total of approximately 
460 subjects (184 each in dinutuximab combination and single-agent irinotecan groups and 92 
in the topotecan group) is expected to yield the requisite number of deaths assuming uniform 
enrollment over 10 months and a follow-up period of 14 months after the last subject is enrolled.  
The mortality rate will be tracked by the Data Monitoring Committee (DMC) and, if lower than 
anticipated, additional subjects may be enrolled to maintain original power specifications for 
the primary efficacy comparison.  
Any decision to extend enrollment will be based on the total number of deaths observed, not on 
the basis of the observed hazard ratio or other unblinded efficacy data.  There is no plan to re-
estimate the sample size in any manner that would affect the Type 1 error rate. 
4.3 
Analysis Data Sets 
The following analysis sets will be used in the study: 
Safety Analysis Set: All subjects who receive at least one dose of any study medication (even 
a partial dose), grouped by actual treatment received.  This set will serve as the basis for the 
evaluation of all safety data, as well as demographic and baseline disease characteristics, prior 
cancer therapy, study drug exposure, and dose modifications. Unless noted otherwise, safety 
data will be summarized or listed separately for Part 1 and Part 2.   
Intent to Treat (ITT) Analysis Set: All subjects randomized in Part 2 of the study, as assigned 
to treatment.  The ITT population is the primary population for the analysis of Overall Survival 
(OS) and will also be used to evaluate all secondary efficacy endpoints and subject 
characteristics.  
Modified Intent to Treat (mITT) Analysis Set: All subjects who were randomized and 
received at least one dose of the study drug in Part 2 of the study, as assigned to treatment.  The 
mITT population is the primary population for the sensitivity analysis of Overall Survival (OS) 
and all secondary efficacy endpoints.   
Efficacy Evaluable: All subjects randomized in Part 2 of the study who have measurable 
disease at baseline, receive any amount of the assigned study treatment, and have at least one 
evaluable post-baseline tumor assessment. Subjects with measurable disease must have at least 
one measurable lesion. Measurable lesions are defined (according to RECIST) as those that 
can be accurately measured in at lHDVWRQHGLPHQVLRQORQJHVWGLDPHWHUWREHUHFRUGHGDV


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mm by chest x-UD\DVPPZLWK&7VFDQRUPPZLWKFDOLSHUVE\FOLQLFDOH[DP 
Together with the ITT population, the Efficacy Evaluable group will be used to evaluate ORR 
and other tumor response endpoints. 
Per Protocol Population: All subjects randomized in Part 2 of the study who satisfy the 
following criteria: 
1) Completed at least 2 cycles of the assigned treatment 
2) Qualified for the study based on SCLC diagnosis and prior therapies (i.e., met protocol 
inclusion criteria 3.1.3, 3.1.4, 3.1.5; did not meet exclusion criterion 3.2.2) 
3) Received at least 80% of the prescribed study drug (i.e., their average dose during the 
treatment period was at least 80% of the planned dose). 
This population will be used for sensitivity analysis of the primary efficacy endpoint. 
4.4 
Disposition of Subjects 
The disposition of all randomized subjects will be summarized according their status at the 
time of analysis. This information will include:  the number of subjects randomized, treated, 
discontinued from treatment, discontinued from the study, and continuing in follow-up.  The 
summary will include reasons for discontinuing study treatment or withdrawing from the study 
as recorded on the eCRF.   
Additionally, data listings will identify any subjects who were randomized into the study but 
did not meet all of the inclusion criteria, met any exclusion criterion, or experienced a major 
protocol violation during the study.   
4.5 
Protocol Deviations and Violations 
Subjects with major protocol deviations/violations will be listed by treatment group.  Protocol 
deviations will be identified via clinical review based on aspects of study conduct that include 
(but are not limited to): (1) eligibility criteria; (2) treatment compliance; (3) subject safety; (4) 
efficacy assessment deviation.  Protocol deviations/violations will be closely monitored during 
the execution of the study and the specific set of protocol deviations/violations that merit 
consideration in the statistical analysis will be finalized before database lock.  
4.6 
Demographic and Other Baseline Characteristics 
All demographic and baseline characteristics will be summarized for the ITT, mITT, and safety 
analysis sets using descriptive statistics. The following baseline data will be summarized to 
describe the study population: 


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x Demographic and Baseline Characteristics (including age, sex, race/ethnicity, 
performance status, region of enrollment, tobacco use, height, weight, and body surface 
area) 
x Cancer History and Baseline Pain (e.g., SCLC stage at initial diagnosis, time since 
initial diagnosis, time since relapse/progression, best response to prior therapy, and 
pre-existing pain assessment) for each treatment group.   
x Tumor Burden at screening visit, defined by:  
o Size of target lesions - sum of recorded diameters for all target lesions 
o Number of non-target lesions (1, 2-3 vs. > 3) 
o Number of involved sites (1, 2-3 vs. > 3) – distinct locations of target and 
non-target lesions 
The 3 treatment groups in Part 2 will be compared using chi-square tests for categorical data 
and F-test from analysis of variance (ANOVA) for continuous data. Any significant imbalances 
detected among the treatment groups will be considered in the analysis. 
4.6.1 
Medical and Surgical History 
Medical history data will be coded using the Medical Dictionary of Regulatory Activities 
(MedDRA), version 20.0 (or higher), and listed by subject. 
4.7 
Prior/Concomitant Treatment 
The WHO Drug Dictionary will be used to classify prior and concomitant medications by 
therapeutic class and preferred term.  Prior medications will be defined as medications taken 
within 30 days prior to the screening visit that were stopped before the first dose of study 
medication.  Concomitant medications will be defined as any medication taken during the study 
between the date of the first dose of study medication and 30 days after the date of the last dose 
(dinutuximab and/or chemotherapy). 
4.7.1 
Prior Cancer Therapy 
The best response to prior cancer therapy and the duration of response to prior first-line 
platinum therapy (FODVVLILHGDVPRQWKVRUPRQWKV) will be summarized by frequency 
table (i.e., number and percentage of subjects in each category).  The type of therapies, details 
of the administration, and best response to each regimen will be listed for each subject. 


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4.7.2 
Concomitant Treatments 
Concomitant medications will be coded using the World Health Organization (WHO) Drug 
Dictionary, version September 2016 (or higher).   
The number and percentage of subjects taking concomitant medications during the treatment 
period will be summarized by anatomical therapeutic chemical (ATC) and preferred term (PT).  
Although a subject may have taken the same medication multiple times, the subject is counted 
only once within an ATC classification.  The same subject may contribute to two or more 
preferred terms in the same ATC classification.  
4.8 
Study Drug Exposure  
4.8.1 
Exposure 
A frequency table will display the number (%) of patients in each treatment group according 
to the total number of cycles initiated, as of the cut-off date for analysis. Duration of treatment 
for each subject will be calculated as the number of days from the date of the first dose of study 
medication to the date of the last dose taken, inclusive.  Duration of treatment, total number of 
doses administered, cumulative dose, dose intensity, and relative dose intensity will be 
summarized for each treatment group and each treatment using descriptive statistics (n, mean, 
median, SD, inter-quartiles, minimum, and maximum) based on the Safety Analysis Set. 
For Part 2 subjects, methods for calculating cumulative actual dose, cumulative planned dose, 
dose intensity, and relative dose intensity for each medication are as follows: 
x Cumulative actual dose (mg/m2): Sum of {Starting dose level for each cycle}; 
x Cumulative planned dose (mg/m2): Sum of {Planned dose level for each cycle}, i.e.; 
o Dinutuximab – (Number of cycles that should have been initiated between the first dose 
date and the last dose date – 1) x 17.5 + 16, if number of cycles 2; otherwise, 16 mg/m2 
if number of cycles = 1; 
o Irinotecan – (Number of cycles that should have been initiated between the first dose 
date and the last dose date) x 350; 
o Topotecan – (Number of cycles that should have been initiated between the first dose 
date and the last dose date) x 1.5 x 5; 
x Dose intensity (mg/m2/day): Cumulative actual dose / (Last dose date – first dose date + 
21); 


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x Relative dose intensity (%): Dose intensity / {Cumulative planned dose / [(Number of 
cycles that should have been initiated between the first dose date and the last dose date) x 
21]} x 100.  
For each treatment administered, infusion start and stop times, the volume infused, and reasons 
for any dose reductions or interruptions will be listed for each subject.  The number of subjects 
requiring a dose modification (reduction, delay or interruption) will be summarized 
descriptively by treatment group.   
4.9 
Efficacy Analysis 
A closed, hierarchical testing procedure will be used to control the overall false-positive rate at 
5% (two-sided) for the primary comparison of dinutuximab + irinotecan versus irinotecan.  The 
primary efficacy endpoint (Overall Survival) will be tested first and, if it achieves statistical 
significance, the secondary endpoints will be tested in the following sequence: PFS, ORR and 
CBR. All the analyses described below will be performed for the purpose of displaying 
summary statistics, but once the first in the sequence of tests yields a p-value that exceeds 0.05, 
the nominal p-value for this and subsequent endpoints in the series will be declared non-
significant. 
4.9.1 
Overall Survival (OS) 
OS is defined as duration of time from the date of randomization to the date of the subject’s 
death from any cause.  Subjects who are alive or permanently lost to follow-up at the cut-off 
date for the analysis will be censored at the last date the subject was known to be alive. 
The primary analysis of OS will be performed in the ITT set using a stratified log-rank test 
(two-sided, alpha=0.05) to evaluate the difference between survival curves for the dinutuximab 
combination group versus the irinotecan group.  Stratification will be based on the same factor 
used for randomization, i.e., the subject’s response to prior platinum therapy (relapse-free 
period during prior platinum treatment < 3 months vs. PRQWKV Similarly, the stratified 
log-rank test will be used to compare OS for the dinutuximab combination group versus the 
topotecan group (an exploratory analysis, not part of the hierarchical procedure described 
above). 
Median OS in each treatment group and the corresponding 2-sided 95% confidence interval 
(CI) will be estimated using the Kaplan-Meier method (Brookmeyer3, 1982).  Kaplan-Meier 
curves for OS distributions will be plotted over time for each treatment group. 


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In addition, two-sided 95% CIs for the OS rate for each treatment will be constructed at pre-
specified time intervals (i.e., 6 months, 12 months, …, etc.), using the log-log transformation 
methodology of Kalbfleisch and Prentice (Kalbfleisch4, 1980) where the estimated variance of 
log(–log(
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Note that the stratified log-rank test will be used for evaluating the treatment difference. The 
Kaplan-Meir plots as well as the summary statistics for median OS and the OS rate will be 
derived from analyses without adjusting for the stratification factor. 
The treatment effect of the dinutuximab combination on OS, as compared to irinotecan, will 
be estimated by the hazard ratio and its 95% CI; the Cox proportional hazards model will be 
used for this analysis, stratified by the subject’s response to prior platinum therapy.  Similarly, 
the hazard ratio and 95% CI comparing the dinutuximab combination group and the topotecan 
group will be provided. 
Sensitivity analyses for the OS endpoint will include an analysis of subjects in the mITT and 
Per Protocol populations (as defined above). An additional sensitivity analysis will be 
performed that considers ITT subjects who were lost to follow as having died on their last 
follow-up date.  
In addition, Cox proportional hazards model will be used to explore the potential impact of 
stratification factors and other baseline covariates on the primary OS endpoint.  The potential 
influence of the following factors will be examined:  age, gender, geographic region of 
enrolling site, ECOG status, duration of prior response to platinum, PD-L1 status (if available), 
and years since diagnosis.  Candidate covariates for the multivariate model will be selected 
using a backward selection process and only variables significant at a 10% level will be 
considered for the final multivariate model. 
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4.9.2 
Progression-Free Survival (PFS) 
PFS is defined as the time from the date of randomization to the date of first documentation of 
tumor progression or death from any cause, whichever occurs first. Tumor response 
assessments will be performed using Response Evaluation Criteria In Solid Tumors (RECIST) 
version 1.1. 
PFS will be evaluated using the stratified log-rank test, as described for OS, with specific 
conventions for censoring.  PFS data will be censored on the date of the last tumor assessment 
documenting absence of PD for subjects who 1) are given anti-tumor treatment other than the 
study treatment prior to observing objective tumor progression; 2) are removed from the study 
prior to documentation of objective tumor progression; 3) are ongoing and do not have 
objective tumor progression at the time of the analysis.  Death or disease progression that 
occurs after more than one missed visit (i.e., 12 weeks) will be censored on the date of the last 
tumor assessment prior to the first missed visit.  Subjects with no post-baseline tumor 
assessments will be censored on the date of randomization. 
4.9.3 
Overall Response Rate (ORR) 
ORR is the percentage of subjects with best overall response (BOR) of either CR or PR.  
Subjects with no post-baseline results will be considered non-responders. ORR will be 
calculated by treatment group for ITT and Efficacy Evaluable subjects.  Both confirmed and 
unconfirmed CR/PR will be tabulated.  The rates will be presented along with two-sided 95% 
exact confidence intervals.  The 95% CIs will be derived using the Clopper-Pearson method.  
This method is commonly used in the literature for reporting tumor response rates and is 
conservative, providing no less than 95% coverage probability even for small N.   
4.9.4 
Clinical Benefit Rate (CBR) 
The CBR is the percentage of subjects with either a CR or PR, or SD.  The rates and the exact 
95% CIs will be provided for each treatment group.  Subjects with no post-baseline tumor 
assessments will be considered to have achieved no clinical benefit.  Subjects will be classified 
as having stable disease if assessed as SD (or better) at least 6 weeks after first dose date. 
Binary endpoints (ORR and CBR) will be analyzed using stratified Cochran-Mantel-Haenszel 
chi-square tests, with two-tailed alpha=0.05.  Odds ratios will be presented along with 
corresponding 95% confidence intervals. 


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4.9.5 
Other Efficacy Outcomes 
Treatment groups will also be compared on the basis of the following additional efficacy 
outcomes, with tumor response defined by RECIST criteria (version 1.1): 
 
Best Overall Response (BOR) 
The BOR is the best response observed from the start of study treatment until the last 
assessment of tumor response recorded during follow-up or the start of any post treatment 
cancer therapy (whichever is sooner), taking into account any requirement for confirmation 
(i.e., at least 4 weeks apart). The number and percentage of subjects in each BOR category (i.e., 
CR, PR, SD, PD, and unevaluable) will be summarized by treatment group. Subjects with 
unconfirmed CR or PR assessments will be categorized separately.  The table will include a 
category for subjects who died or discontinued the study due to disease progression prior to the 
first tumor assessment, as well as ongoing subjects without a tumor assessment prior to the data 
cut-off date for analysis.  Subjects will be classified as having stable disease if assessed as SD 
(or better) at least 6 weeks after first dose date.   
Data listings will display target lesion measurements and non-target lesion response 
assessments at each timepoint, together with the level of tumor response assigned by the 
investigator.     
Time to Response (TTR) 
The TTR is defined as the time interval between the date of randomization and the date of first 
documented CR or PR.  CR or PR requires confirmation at least 4 weeks apart.  Once it is 
confirmed, the first documented CR or PR will be considered as the start of the response. TTR 
will be descriptively summarized for subjects who responded. 
Duration of response (DOR) 
The DOR is defined as the time interval between the date of first documented PR or CR and 
the subsequent first date of disease progression as determined by radiological assessment using 
RECIST criteria (version 1.1) or death. 
Subjects who do not experience disease progression and have not died will be censored on the 
date of their last tumor assessment.  Disease progression that occurs after more than one missed 
visit (i.e., 12 weeks) will be censored on the date of the last tumor assessment prior to the first 


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missed visit. For OS, the death date will be used as an event time, no matter how many prior 
visits were missed. 
DOR for subjects who achieve a PR and then a CR will be calculated starting from the date of 
the PR.  Duration of response will be derived as (earliest date of progression or death) – (date 
of first documented objective response) + 1.  Duration of response will be summarized 
descriptively for each treatment group using Kaplan-Meier methods, as appropriate.   
4.9.6 
Subgroup Analysis 
For exploratory purposes, the analysis of OS will be performed within subgroups of subjects 
in the ITT Analysis Set defined by the following criteria. The same method used for the analysis 
of the primary efficacy endpoint (OS) will be applied except that the stratification factor will 
not be included in the analysis of the prior platinum response subgroups. 
x Prior Platinum Response (relapse-IUHHPRQWKVYVPRQWKV 
x $JH*URXS\HDUVYV\HDUV 
x Sex (male vs. female) 
x Geographic Region (North America/Europe/Asia-Pacific) 
x Baseline Tumor Burden (Lowest, Middle, Highest Tertile)  
x GD2 expression (positive vs. negative) 
 
In addition, the impact of steroid use on the treatment effect of dinutuximab will be explored.  
  
4.10 Safety Analysis 
4.10.1 
Adverse Events – Part 1 
Toxicities reported during Part 1 (intrasubject dose escalation) will be listed for individual 
subjects by dinutuximab dose at time of onset.  Pain severity scores will also be listed by 
dinutuximab dose, cycle, and time since start of infusion. 
4.10.2 
Adverse Events – Part 2 
AEs will be coded using MedDRA Version 20.0 or higher.  Treatment-emergent AEs (TEAEs) 
will be grouped and tabulated by the MedDRA System Organ Class (SOC) and Preferred Term 
(PT).  An AE that starts or increases in severity after the first dose of study medication and up 


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until 30 days after the last dose will be considered a TEAE.  Severity of the AEs will be graded 
according to the NCI CTCAE Version 4.03.   
All safety summaries will be generated for the Safety Analysis Set.   
A safety overview table will present the number (%) of subjects in each treatment group with 
events in the following categories: 
x Any TEAEs 
x Treatment-Related TEAEs 
x *UDGH TEAEs 
x *UDGHTreatment-Related TEAEs 
x Treatment-Emergent Serious Adverse Events (SAEs) 
x Treatment-Related SAEs 
x *UDGH6$(V 
x *UDGH7UHDWPHQW-Related SAEs 
x TEAEs leading to Discontinuation of Study Treatment 
x TEAEs leading to Reduction in Dose of Study Treatment 
x Fatal TEAEs 
x Fatal Treatment-Related TEAEs 
For these events, the difference between incidence rates for Group B (dinutuximab + 
irinotecan) minus Group A (irinotecan) will be presented, together with its 2-sided 95% 
FRQILGHQFHLQWHUYDOFDOFXODWHGXVLQJWKH:LOVRQVFRUHPHWKRG$ORZHUERXQGޓ]HURPD\
indicate excess risk in the dinutuximab group. The Wilson score method will be used to 
calculate 95% confidence intervals to ensure actual coverage closest to the nominal level.   
The number and percentage of subjects experiencing TEAEs will also be summarized by SOC 
and PT.  The following tables will be generated: 
x Overall TEAEs 
x Dinutuximab-Related TEAEs 
x Irinotecan/Topotecan-Related TEAEs 
x Grade 3 TEAEs,  
x Dinutuximab-Related Grade TEAEs 
x Irinotecan/Topotecan-5HODWHG*UDGHTEAEs 
x TEAEs leading to discontinuation of Dinutuximab 


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x TEAEs leading to discontinuation of Irinotecan/Topotecan 
x TEAEs leading to dose reduction of Dinutuximab 
x TEAEs leading to dose reduction of Irinotecan/Topotecan 
x Treatment-emergent SAEs 
x Treatment-emergent SAEs related to Dinutuximab 
x Treatment-emergent SAEs related to Irinotecan/Topotecan 
x TEAEs with an outcome of death 
x TEAEs by Maximum Grade 
x TEAEs of special interest 
Adverse events of special interest are defined as: 
x Severe non-hematologic toxicities including allergic reactions (anaphylaxis) 
x Severe neuropathic pain unresponsive to treatment 
x Prolonged motor weakness (>2 weeks in duration) 
x Acute Grade 4 vascular leak syndrome 
x Grade 3 visual toxicity 
By-subject data listings of AEs will provide the AE verbatim term, SOC, PT, onset date/day 
relative to start of study treatment, severity, outcome, and relationship to study treatment.  
Separate listings will be generated for all AEs (regardless of treatment emergence), *UDGH
AEs, all treatment-related AEs, all SAEs, AEs that lead to discontinuation of any study 
treatment, AEs with a fatal outcome, and all deaths.  The listing of deaths will include the date 
and cause of death, number of days from randomization, and number of days from last dose of 
study treatment. 
4.10.3 
Pain Medications and Infusion Related Reaction Medications 
Pain medications and other treatments administered to prevent or alleviate pain and infusion 
reactions (including drugs initiated during the infusion period) will be summarized separately 
for each treatment group. The number and percentage of subjects in each treatment group will 
be summarized by ATC code. All concomitant medications, including name of drug, 
indication, dose, frequency, mode of administration, and start/stop day relative to start of study 
treatment, will be listed by subject. 


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4.10.4 
Clinical Laboratory Parameters 
Hematology and blood chemistry data will be graded according to NCI CTCAE v4.03. The 
frequencies of the worst severity grade observed will be displayed for each parameter. 
Laboratory data will also be summarized descriptively based on observed values at each 
scheduled visit and the change from baseline values at each post-baseline visit. 
Baseline is defined as the last evaluation prior to the first dose of study drug.  Shift tables from 
baseline to the worst post- baseline values will be provided for laboratory parameters that have 
NCI-CTCAE v4.03 toxicity grades.  Both scheduled and unscheduled post-baseline values 
during the treatment period will be considered. 
Additionally, the number and percentage of subjects in each treatment group experiencing at 
least one Grade 3 or 4 event will be tabulated for each NCI CTCAE gradable laboratory test.  
All clinical laboratory data will be listed by subject and will be structured to permit review of 
the data over time relative to the start of treatment.  Values outside the normal ranges will be 
flagged and toxicity grades will be displayed for relevant parameters.   
Serology testing was not mandatory and discontinued during the study. Serology data collected 
will be included in the database, but will not be presented in data listings for the CSR. 
4.10.5 
Vital Signs 
Vital sign measurements will be summarized at each infusion, by treatment, using descriptive 
statistics; change from baseline values will be presented for each timepoint for the Safety 
Analysis Set.  Summary statistics by treatment group will be based on vital sign assessments 
obtained prior to the first dose of each cycle.  Clinically significant post-baseline vital sign 
findings will be reported as AEs. A by-subject data listing of all vital sign data will be 
generated.  
4.10.6 
Physical Examinations 
Information on physical examinations will be listed by subject.  Clinically significant post-
baseline physical examination findings will be reported as AEs. 
Neurological assessments will be tabulated using shift tables to categorize subjects according 
to the change from baseline evaluation to each post baseline visit (Normal, Abnormal – not 


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clinically significant, Abnormal – clinically significant), for each item in the assessment scale 
(e.g., mental status, coordination and gait, …, etc.), by treatment group. 
4.10.7 
ECOG Performance Status 
ECOG performance status scores will be summarized by treatment group.  Frequency counts 
and percentages for the EOT assessment will be presented.    


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5 
INTERIM DATA MONITORING 
An independent DMC will review accumulating safety data at scheduled intervals during Part 2 
of the study.  Attention will focus on the percentage of subjects with SAEs, AEs of special 
interest, fatal events, and Grade 3 or 4 toxicities, with the severity and relationship to study 
medication(s) taken into consideration.  Details regarding DMC member roles, the frequency 
of DMC meetings, contents of safety reports, and procedural aspects of DMC meetings will be 
described in the DMC charter.  Excess risk will be determined according to the lower 97.5% 
lower confidence bound on the difference between incidence rates for Group B (dinutuximab 
+ irinotecan) minus Group A (irinotecan alone).  Incidence calculations will depend on the 
respective numerators and denominators at the time of each interim look. Wilson scores method 
will be used to calculate confidence limits to ensure that actual coverage is close to the nominal 
level.  
In addition to the safety monitoring, the DMC will review risk-benefit based on investigator-
assessed tumor response rates and consider stopping the study early if trends are unfavorable. 
A short-term endpoint, ORR, will be used for futility assessment.  Futility will be based on 
interim ORR values and the resulting conditional power (CP).  The DMC will use CP values 
to judge the likelihood that the completed trial will demonstrate significantly higher ORR in 
Group B (dinutuximab + irinotecan) versus Group A (irinotecan alone). The methodology for 
conditional power estimation is described in Proschan, Lan and Wittes (2006). 
No formal interim analysis of OS is planned. However, the number and causes of death in each 
treatment group will be reviewed by the DMC from a safety perspective. Mortality rates will 
also be assessed using confidence boXQGVDVGHVFULEHGDERYH$ORZHUOLPLWޓZRXOGEH
grounds for stopping the study due to elevated mortality risk associated with dinutuximab.   
The planned approach to interim data monitoring will not impact the Type I error rate for the 
primary efficacy analysis because there is no possibility of stopping for efficacy.  Any decision 
to stop the study would be based on safety issues or futility (the absence of an efficacy signal 
for tumor response), not a positive effect on survival. 
Selected safety and efficacy tables, listings, and figures will be provided for DMC review 
meetings.  Details of the DMC analysis plan will be provided in the DMC Charter. 


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6 
REFERENCES 
1. International Conference on Harmonisation of Technical Requirements for Registration 
of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Statistical 
Principles for Clinical Trials (E9), 5 February 1998. 
2. International Conference on Harmonisation of Technical Requirements for Registration 
of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Structure 
and Content of Clinical Study Reports (E3), 30 November 1995. 
3. Brookmeyer R, Crowley J. A confidence interval for the median survival time. 
Biometrics. 1982; 38: 29-41. 
4. Kalbfleisch JD, Prentice RL. (1980) The statistical analysis of failure time data. John 
Wiley & Sons, Inc.  
5. Proschan MA, Lan GKK, and Wittes JT. (2006) Statistical Monitoring of Clinical Trials 
– A Unified Approach.  Springer Science, New York, NY.  


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7 
PROGRAMMING CONSIDERATIONS 
All tables, data listings, figures (TLFs), and statistical analyses will be generated using SAS® 
Version 9.4 (or higher). Generated outputs will adhere to the following specifications. 
7.1 
Table, Listing, and Figure Format 
7.1.1 
General 
1) All TLFs will be produced in landscape format. 
2) All TLFs will be produced using the Courier New font, size 9. 
3) The data displays for all TLFs will have a 1.5-inch binding margin on top of a landscape 
oriented page and a minimum 1-inch margin on the other 3 sides. 
4) Headers and footers for figures will be in Courier New font, size 9. 
5) Legends will be used for all figures with more than 1 variable, group, or item displayed. 
6) Tables and listings will be in black and white (no color). Figures may be in color. 
7) Specialized text styles, such as bolding, italics, borders, shading, and superscripted and 
subscripted text, will not be used in the TLFs. On some occasions, superscripts 1, 2, or 
3 may be used (see below). 
8) Only standard keyboard characters will be used in the TLFs. Special characters, such 
as non-printable control characters, printer-specific, or font-specific characters, will not 
be used. Hexadecimal-derived characters will be used, where possible, if they are 
DSSURSULDWHWRKHOSGLVSOD\PDWKV\PEROVHJȝ&HUWDLQVXSHUVFULSWVHJFP2) will 
be employed on a case-by-case basis. 
9) Mixed case will be used for all titles, footnotes, column headers, and programmer-
supplied formats. 
7.1.2 
Headers 
All output will have the following header at the top of the page: 


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Product: DINUTUXIMAB                               Page n of N 
Protocol: DIV-SCLC-301                    United Therapeutics  
 
 
  
All output will have page numbers. TLFs should be internally paginated in relation to the total 
length (i.e., the page number should appear sequentially as page n of N, where N is the total 
number of pages in the table). 
7.1.3 
Display Titles 
Each TLF will be identified by a numeral, and the designation (i.e., Table 1) should be centered 
above the title. A decimal system (Table 14.x.y.z, Figure 14.x.y.z, and Listing 16.2.x.y) should 
be used to identify TLFs with related contents. The title will be centered in initial capital 
characters. The analysis set will be identified on the line immediately following the title. The 
title and table designation will be single spaced. A solid line spanning the margins will separate 
the titles from the column headers. There will be 1 blank line between the last title line and the 
solid line. 
Table 14.x.y-z 
First Line of Title 
Second Line of Title if Needed 
Safety Analysis Set 
7.1.4 
Column Headers 
1) Column headings will be displayed immediately below the solid line described above, 
in initial upper-case characters. 
2) For numeric variables, units will be included in column or row heading when 
appropriate. 
3) Analysis set sizes will be presented for each treatment cohort in the column heading as 
(N=xx) (or in the row headings if applicable). This is distinct from the ‘n’ used for the 
descriptive statistics representing the number of subjects in the analysis set. 
4) The order of treatments in the tables and listings will be: (listing only), Dinutuximab + 
Irinotecan, Irinotecan, Topotecan, and Total [if applicable]). 


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7.1.5 
Body of the Data Display 
1) Listings will be sorted for presentation in order of schedule, treatment cohort, subject 
ID, collection day, and collection time. 
2) If the categories of a parameter are ordered, then all categories between the maximum 
and minimum category will be presented in the table, even if n=0 for all treatment 
groups in a given category that is between the minimum and maximum level for that 
parameter. For example, the frequency distribution for symptom severity would appear 
as: 
Severity Rating 
n 
Grade 1 
20 
Grade 2 
5 
Grade 3 
3 
Grade 4 
5 
Grade 5 
0 
Where percentages are presented in these tables, any counts of 0 will be presented as 0 
and not as 0 (0%). 
3) If the categories are not ordered (e.g., Medical History, Reasons for Discontinuation 
from the Study, etc.), then only those categories for which there is at least 1 subject 
represented in 1 or more groups will be included. 
4) An Unknown or Missing category will be added to the summary of any categorical 
parameter for which information is not available for 1 or more subjects. 
5) Unless otherwise specified, the estimated mean and median for a set of values will be 
presented to 1 more significant digit than the original values, and standard deviations 
will be presented to 2 more significant digits than the original values. The minimum 
and maximum will report the same number of significant digits as the original values. 
For example, for systolic blood pressure: 
n 
XX 
Mean (SD) 
XXX.X (X.XX) 
 
 
Median 
XXX.X 
Min - Max 
XXX, XXX 
 
 
6) Data in columns of a table will be formatted as follows: 


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x alphanumeric values left-justified; 
x whole numbers (e.g., counts) right-justified; and 
x numbers containing fractional portions decimal-aligned. 
7) Percentage values will be formatted with 1 digit to the right of the decimal point in 
parentheses, 1 space after the count (e.g., 7 (12.8%), 13 (5.4%)). Less-than signs (e.g., 
“<0.1%”) will appear when values are >0.0% and <0.1% (but not equal to 0.0%). Unless 
otherwise noted, for all percentages, the number of subjects in the analysis set for the 
treatment cohort who have an observation (i.e., at risk) will be the denominator. 
8) Tabular displays of data for prior/concomitant medications and all tabular displays of 
adverse event data will be presented by the drug class, or SOC with the highest 
occurrence in the MTD cohort(s) (Schedule 1 and Schedule 2 separately), in decreasing 
order. Within the drug class and SOC, drugs (by ATC code), and adverse events (by 
PT) will be displayed in decreasing order. If the incidences for multiple terms are 
identical, they will be sorted alphabetically. 
9) Missing data will be represented on subject listings as either a hyphen (“-”) with a 
corresponding footnote (“ - = unknown or not evaluated”), or as “N/A” (footnote “N/A 
= not applicable”), whichever is appropriate. Missing descriptive statistics or p-values 
due to non-estimability will be reported as “-” with a corresponding footnote (“- = not 
estimable”). 
10) Dates will be formatted in SAS®ISO date format yyyy-mm-dd (e.g., “2000-07-01”). 
Missing portions of dates will be represented on subject listings as blank (e.g., “2000-
07”). Dates that are missing because they are not applicable for the particular subject 
will be presented as “N/A”, unless otherwise specified. 
11) All observed time values will be presented using a 24-hour clock in hh:mm:ss format 
(e.g., “01:35:45”, “21:26”). Time values will be reported only if they were measured as 
part of the study. Vital signs measured relative to dinutuximab infusion are captured on 
a single date. If clock times run past 24:00 for a given cycle, then add +1 to date. 
7.1.6 
Footnotes 
1) A solid line spanning the margins will separate the body of the data display from the 
footnotes.  


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2) All footnotes will be left justified with single-line spacing immediately below the solid 
line underneath the data display. 
3) Informational footnote will begin with “Note:”. Annotation footnotes will begin with 
an asterisk and other non-numeric symbol. Each new footnote will start on a new line. 
4) Footnotes will appear on each page. Subject specific footnotes will be avoided. 
5) Footnotes will be used sparingly, and only if they add value to the table, figure, or data 
listing. If a data display has more than 4 footnotes, then a cover page may be used to 
display footnotes, and only those footnotes essential to comprehension of the data will 
be repeated on each page. Footnotes will not repeat definitions already provided in the 
SAP. 
6) The last line of the footnote section will be a standard source line, indicating the data 
source used by the SAS program that produced the data display, the name of the SAS 
program, and running date/time. 
7.2 
Data-Handling Rules 
This section describes naming conventions and rules for calculations common to all applicable 
tables. Some rules specific to a table can be found in the relevant mock-ups. 
7.2.1 
Unit Conversion to Months 
If months are calculated for a duration, the following conversion is used. 
1) Duration (months): {Duration (days)} / 30.42 
7.2.2 
Visits 
1) Relative Study Day: The first day of study treatment is Day 1. A minus (-) sign indicates 
days prior to the start of study treatment (e.g., Day -5 represents 5 days before start of 
the study treatment. There is no Day 0.). The relative study day for a specific visit is 
calculated as (Visit Date – Date of First Dose +1). 
2) Baseline: For all study variables, baseline is defined as the last measurement obtained 
prior to the first dose of the study treatment.  
7.2.3 
Demographics and Baseline Characteristics 
1) Age = (Date of informed consent–Date of birth + 1) / 365.25 and truncated to complete 
years. 


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2) Conversion factors and calculations for height, weight, BMI and BSA: 
a) Height (in cm) = height (in inches) * 2.54 
b) Weight (in kg) = weight (in lbs) * 0.4536 
c) BMI (kg/m2) = Weight(kg)/[Height(m)2] 
d) BSA (m2) = ([Weight (kg) x Height (cm)] / 3600)1/2  
3) Geographic regions will be defined as follows:   
North America 
Canada, US 
Western Europe  
France, Italy, Spain, UK 
Central/Eastern Europe 
Bulgaria, Georgia, Hungary, Lithuania, Poland, Slovakia 
Russia & Ukraine 
Russia, Ukraine 
Asia-Pacific 
Australia, Hong Kong, India, Korea, Malaysia, Philippines, Taiwan, and 
Thailand 
 
7.2.4 
Prior and Concomitant Medications 
1) Prior and concomitant medications will be coded and classified using the World Health 
Organization (WHO) Drug Dictionary (September 2016 or higher). The specific 
dictionary version will appear in the footnote of the SAS tables/listings. 
2) Counting rules for prior/concomitant medications: Prior medications include 
medications that were taken prior to the start of study treatment but stopped before the 
first dose of study treatment. Concomitant medications during treatment period include 
medications that started at any time and were taken at any time after the start of study 
treatment until the 30 days after the end of study treatment. 
3) Medications missing both start and stop dates, or having a start date prior to 30 days 
post the last dose of study treatment with the stop date missing, or having a stop date 
after the start of study treatment with the start date missing, will be counted as 
concomitant. When partial dates are present in the data, both a partial start date and/or 
a partial stop date will be evaluated to determine whether it can be conclusively 
established that the medication either ended prior to the start of study treatment or 
started after 30 days post the end of study treatment. If the above cannot be conclusively 
established based on the partial and/or present dates, then the medication will be 
counted as concomitant. 


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7.2.5 
Safety 
1) Adverse events will be coded and classified using MedDRA 20.0 or higher. The specific 
dictionary version will appear in a footnote of the SAS tables/listings. 
2) Counting rules for AEs: AEs with missing start dates, but with stop dates either 
overlapping the treatment period or missing, will be counted as treatment-emergent, 
taking the worst-case approach. Special care will be taken regarding partial dates, 
applying similar logic to that of the prior/concomitant medications. 
3) For purposes of flagging individual subject data, laboratory test result abnormalities are 
defined as values above or below the normal range. 
7.2.6 
SAS® Procedures 
This section provides sample SAS® code to illustrate statistical analyses specified in the 
statistical methods section. All computer output from SAS® statistical procedures serving as a 
basis for extracted results (e.g., LIFETEST) will be retained for quality control procedures and 
will be included in CSR appendices. 
Exact 95% confidence interval on ORR/DCR: 
proc freq; 
 
by trt; 
 
table resp / binomial; 
run;  
Median survival time and survival rates with 95% confidence intervals: 
proc lifetest method=lt intervals =(0 to 24 by 6) outsurv=surv; 
 
time tte*censor(0); 
 
strata trt 
run;  
 
Note: 95% confidence intervals for time intervals (e.g., 3 months, 6 months) will be 
extracted from the data set SURV. 
 
Cox proportional hazard ratio: 
proc phreg data=kmvar; 
 
model aval*cnsr(1) = trtpn/rl; 
 
strata st1n; 
run;  


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Stratified log-rank test p-value: 
Ods output HomTests=pval; 
proc lifetest data=kmvar; 
 
time aval*cnsr(1); 
 
strata st1n / group = trtpn; 
run;  
 
Additional SAS® code is provided, where necessary, in programming notes for table mock-ups.   


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8 
LIST OF TABLES, LISTINGS, AND FIGURES 
8.1 
LIST OF TABLES 
Table Number 
Table Title 
14.1.1.1 
Subject Disposition (Part 1) - All Subjects 
14.1.1.2 
Subject Disposition (Part 2) - All Subjects 
14.1.1.3 
Data Sets Analyzed - All Subjects 
14.1.1.4 
Protocol Violation/Deviations – ITT Analysis Set  
14.1.2.1.1 
Demographic and Baseline Characteristics – ITT Analysis Set 
14.1.2.1.2 
Demographic and Baseline Characteristics – Safety Analysis Set 
14.1.2.1.3 
Cancer History – ITT Analysis Set 
14.1.2.1.4 
Baseline Pain Assessment – ITT Analysis Set 
14.1.2.1.5 
Baseline Pain Assessment – Safety Analysis set 
14.1.2.1.6 
Summary of ECG Parameters – Safety Analysis Set 
14.1.2.2.1 
Prior Therapy for SCLC – ITT Analysis Set 
14.1.2.2.2 
Prior Therapy for SCLC – Safety Analysis Set 
14.1.2.3.1 
Summary of Concomitant Medications - Safety Analysis Set 
14.1.3.1 
Exposure to Study Treatment – Safety Analysis Set 
14.1.3.2 
Dinutuximab Dose Modifications – Safety Analysis Set 
14.1.3.3 
Irinotecan/Topotecan Dose Modifications – Safety Analysis Set 
14.2.1.1 
Summary of Overall Survival (OS) – ITT Analysis Set 
14.2.1.1.1 
Summary of Overall Survival (OS) by Prior Platinum Response (relapse-free 
< 3 months vs. >= 3 months) – ITT Analysis Set 
14.2.1.1.2 
Summary of Overall Survival (OS) by Age Group (<65 years vs. >= 65 years) 
– ITT Analysis Set 
14.2.1.1.3 
Summary of Overall Survival (OS) by Geographic Region (North America vs. 
Europe vs. Asia-Pacific) – ITT Analysis Set 
14.2.1.1.4 
Summary of Overall Survival (OS) by Tumor Burden (Lower, Middle, and 
Highest Tertile) – ITT Analysis Set 
14.2.1.2 
Summary of Overall Survival (OS) – mITT Analysis Set 


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Table Number 
Table Title 
14.2.1.3 
Summary of Overall Survival (OS) [Sensitivity 1: “Per Protocol Population” 
(Patients who were protocol compliant and received >= 80% assigned 
dose)] 
14.2.1.4 
Summary of Overall Survival (OS) [Sensitivity 2: Consider subjects lost to 
follow-up as deaths at last follow-up date] 
14.2.1.5 
Effect of Prognostic Factors on Overall Survival (OS) – ITT Analysis Set 
14.2.1.6 
Final Prognostic Factor Model for Overall Survival (OS) – ITT Analysis Set 
14.2.2.1 
Summary of Progression-Free Survival (PFS) – ITT Analysis Set 
14.2.2.2 
Summary of Progression-Free Survival (PFS) – mITT Analysis Set 
14.2.3.1 
Summary of Best Overall Response – ITT Analysis Set 
14.2.3.2 
Summary of Best Overall Response – mITT Analysis Set 
14.2.3.3 
Summary of Best Overall Response – Efficacy Evaluable 
14.2.3.4 
Summary of Clinical Benefit Rate – ITT Analysis Set 
14.2.3.5 
Summary of Clinical Benefit Rate – mITT Analysis Set 
14.2.3.6 
Summary of Clinical Benefit Rate – Efficacy Evaluable 
14.2.4.1 
Summary of Time to Response –ITT Analysis Set 
14.2.5.1 
Summary of Duration of Response – ITT Analysis Set 
14.3.1.1.1 
Overview of Adverse Events (Part 1) – Safety Analysis Set 
14.3.1.1.2 
Overview of Adverse Events (Part 2) – Safety Analysis Set 
14.3.1.2 
Number (%) of Subjects with Treatment-Emergent Adverse Events (TEAEs), 
By System Organ Class and Preferred Term – Safety Analysis Set 
14.3.1.3.1 
Number (%) of Subjects with Dinutuximab Related TEAEs By System Organ 
Class and Preferred Term – Safety Analysis Set 
14.3.1.3.2 
Number (%) of Subjects with Irinotecan or Topotecan Related Adverse 
Events By System Organ Class and Preferred Term – Safety Analysis Set 
14.3.1.3.3 
Number (%) of Subjects with Any Treatment Related Adverse Events By 
System Organ Class and Preferred Term – Safety Analysis Set 
14.3.1.4 
Number (%) of Subjects with Treatment-Emergent Adverse Events (TEAEs) 
By System Organ Class, Preferred Term, and Highest CTCAE Grade – Safety 
Analysis Set 


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Table Number 
Table Title 
14.3.1.5.1 
Number (%) of Subjects with Dinutuximab Related TEAEs by System Organ 
Class, Preferred Term, and Highest CTCAE Grade – Safety Analysis Set 
14.3.1.5.2 
Number (%) of Subjects with Irinotecan or Topotecan Related TEAEs by 
System Organ Class, Preferred Term, and Highest CTCAE Grade – Safety 
Analysis Set 
14.3.1.5.3 
Number (%) of Subjects with Any Treatment Related Adverse Events by 
System Organ Class, Preferred Term, and Highest CTCAE Grade – Safety 
Analysis Set 
14.3.1.6 
Number (%) of Subjects with Grade >= 3 Treatment-Emergent Adverse 
Events By System Organ Class and Preferred Term – Safety Analysis Set 
14.3.1.7.1 
Number (%) of Subjects with Dinutuximab Related Grade >= 3 Adverse 
Events By System Organ Class and Preferred Term – Safety Analysis Set 
14.3.1.7.2 
Number (%) of Subjects with Irinotecan or Topotecan Related Grade >= 3 
Adverse Events By System Organ Class and Preferred Term – Safety 
Analysis Set 
14.3.1.7.3 
Number (%) of Subjects with Any Treatment-Related Grade >= 3 Adverse 
Events By System Organ Class and Preferred Term – Safety Analysis Set 
14.3.1.8 
Number (%) of Subjects with Treatment-Emergent Serious Adverse Events 
By System Organ Class and Preferred Term – Safety Analysis Set 
14.3.1.9.1 
Number (%) of Subjects with Dinutuximab Related Serious Adverse Events 
By System Organ Class and Preferred Term – Safety Analysis Set 
14.3.1.9.2 
Number (%) of Subjects with Irinotecan or Topotecan Related Serious 
Adverse Events By System Organ Class and Preferred Term – Safety 
Analysis Set 
14.3.1.9.3 
Number (%) of Subjects with Any Treatment-Related Serious Adverse 
Events By System Organ Class and Preferred Term – Safety Analysis Set 
14.3.1.10.1 
Number (%) of Subjects with Treatment-Emergent Adverse Events (TEAEs) 
Leading to Dinutuximab Discontinuation By System Organ Class and 
Preferred Term – Safety Analysis Set 
14.3.1.10.2 
Number (%) of Subjects with Treatment-Emergent Adverse Events (TEAEs) 
Leading to Irinotecan or Topotecan Discontinuation By System Organ Class 
and Preferred Term – Safety Analysis Set 


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Table Number 
Table Title 
14.3.1.10.3 
Number (%) of Subjects with Treatment-Emergent Adverse Events (TEAEs) 
Leading to Any Treatment Discontinuation By System Organ Class and 
Preferred Term – Safety Analysis Set 
14.3.1.11.1 
Number (%) of Subjects with Treatment-Emergent Adverse Events (TEAEs) 
Leading to Dinutuximab Reduction By System Organ Class and Preferred 
Term – Safety Analysis Set 
14.3.1.11.2 
Number (%) of Subjects with Treatment-Emergent Adverse Events (TEAEs) 
Leading to Irinotecan or Topotecan Reduction By System Organ Class and 
Preferred Term – Safety Analysis Set 
14.3.1.11.3 
Number (%) of Subjects with Treatment-Emergent Adverse Events (TEAEs) 
Leading to Any Treatment Reduction By System Organ Class and Preferred 
Term – Safety Analysis Set 
14.3.1.12 
Number (%) of Subjects with Treatment-Emergent Fatal Adverse Events by 
System Organ Class and Preferred Term – Safety Analysis Set 
14.3.2.1.1 
Summary of Chemistry Laboratory Values and Change from Baseline – 
Safety Analysis Set 
14.3.2.1.2 
Summary of Hematology Laboratory Values and Change from Baseline – 
Safety Analysis Set 
14.3.2.3.1 
Shift Table for Laboratory Parameters with Single Direction - Safety 
Analysis Set 
14.3.2.3.2 
Shift Table for Laboratory Parameters with Both Low and High Directions - 
Safety Analysis Set 
14.3.3.1.1 
Summary of Vital Signs and Change from Baseline – Safety Analysis Set 
14.3.3.2 
Summary of Weight Values and Change from Baseline – Safety Analysis Set 
14.3.4 
Shift Table for Neurological Assessment – Safety Analysis Set 
14.3.5 
ECOG Performance Status – Safety Analysis Set 
14.3.6.1 
Summary of Concomitant Pain Medications – Safety Analysis Set 
 
8.2 
LIST OF LISTINGS 
Listing Number 
Listing Title 
16.2.1 
Subject Disposition 
16.2.2.1 
Protocol Deviations 


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Listing Number 
Listing Title 
16.2.2.2 
Inclusion/Exclusion Criteria 
16.2.3 
Analysis Population 
16.2.4.1 
Demographics 
16.2.4.2.1 
Small Cell Lung Cancer Disease History 
16.2.4.2.2.1 
Prior Cancer Therapy 
16.2.4.2.2.2 
Post Study Cancer Therapy 
16.2.4.2.3.1 
Prior Cancer Surgery 
16.2.4.2.3.2 
Post Study Cancer Surgery 
16.2.4.2.4.1 
Prior Radiotherapy 
16.2.4.2.4.2 
Post Study Radiotherapy 
16.2.4.3 
Tobacco History 
16.2.4.4 
Medical History 
16.2.4.5 
Prior Medication 
16.2.4.6.1 
Concomitant Medication 
16.2.4.6.2 
Concomitant Pain Medication 
16.2.5.1 
Dinutuximab Administration 
16.2.5.2 
Irinotecan Administration 
16.2.5.3 
Topotecan Administration 
16.2.5.4 
Extent of Exposure 
16.2.6.1 
Progression-Free Survival (PFS) Per RECIST and Overall Survival 
16.2.6.2 
Tumor Assessment Details (RECIST) 
16.2.6.3 
Time to Response and Duration of Response per RECIST 
16.2.6.4 
PD-L1 Test and Biomarker Assessment 
16.2.7.1 
Adverse Events 
16.2.7.2 
Listing of Treatment-Related Adverse Events 
16.2.7.3 
Listing of Grade >=3 Adverse Events 
16.2.7.4 
Listing of Serious Adverse Events (SAEs) 
16.2.7.5 
Listing of Adverse Events Leading to Discontinuation of Any 
Treatment 
16.2.7.7 
Listing of Fatal Adverse Events 
16.2.8.1 
Laboratory Assessment – Chemistry 


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Listing Number 
Listing Title 
16.2.8.2 
Laboratory Assessment – Hematology 
16.2.8.3 
Laboratory Assessment – Pregnancy Test 
16.2.9.1 
Vital Signs and Weight 
16.2.9.2 
Physical Examination 
16.2.9.3 
Neurological Assessment 
16.2.9.4 
ECOG Performance Status 
16.2.9.5 
Numeric Pain Assessment 
16.2.9.6 
Electrocardiogram Assessment 
 
8.3 
LIST OF FIGURES 
Figure Number 
Figure Title 
14.2.1.1 
Plot of Kaplan-Meier Curve for Overall Survival – ITT Analysis Set 
14.2.1.1.1 
Plot of Kaplan-Meier Curve for Overall Survival by Prior Platinum 
Response [relapse-free < 3 months vs. >= 3 months] – ITT Analysis Set 
14.2.1.1.2 
Plot of Kaplan-Meier Curve for Overall Survival by Age Group [< 65 years 
vs. >= 65 years] – ITT Analysis Set 
14.2.1.1.3 
Plot of Kaplan-Meier Curve for Overall Survival by Geographic Region 
[North America/Europe/Asia-Pacific] – ITT Analysis Set 
14.2.1.1.4 
Plot of Kaplan-Meier Curve for Overall Survival by Baseline Tumor 
Burden [Lowest, Middle, and Highest] –ITT Analysis Set 
14.2.1.2 
Plot of Kaplan-Meier Curve for Overall Survival – mITT Analysis Set 
14.2.1.3 
Plot of Kaplan-Meier Curve for Overall Survival [Sensitivity 1: “Per 
Protocol Population” (Subjects who were protocol compliant and 
received >= 80% assigned dose)] 
14.2.1.4 
Plot of Kaplan-Meier Curve for Overall Survival [Sensitivity 2: counting 
subjects lost to follow-up as deaths at time of last follow-up] 
14.2.2.1 
Plot of Kaplan-Meier Curve for Progression-free Survival – ITT Analysis 
Set 
14.2.2.2 
Plot of Kaplan-Meier Curve for Progression-free Survival – mITT Analysis 
Set 


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Figure Number 
Figure Title 
14.2.3 
Maximum Percent Change in Tumor Burden by Best Overall Response 
(RECIST v1.1) – Waterfall plot – ITT Analysis Set