Clinical trial NCT03594747
Conditions: Non-Small Cell Lung Cancer
Sponsor: BeiGene
Start date: 2018-07-30; Completion date: 2023-04-28
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced squamous non-small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days) arm 2: Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days) arm 3: Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
Interventions: intervention 1: Tislelizumab intervention 2: Paclitaxel intervention 3: Nab-paclitaxel intervention 4: Carboplatin
Intervention descriptions: intervention 1: Administered intravenously as described intervention 2: Administered intravenously as described intervention 3: Administered intravenously as described intervention 4: Administered intravenously as described

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 
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     BGB-A317-307 
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STATISTICAL ANALYSIS PLAN 
Study Protocol 
Number: 
BGB-A317-307 
Study Protocol 
Title: 
A Phase 3, Multicenter, Randomized Open-Label Study to Compare the 
Efficacy and Safety of Tislelizumab (BGB-A317, Anti-PD1 Antibody) 
Combined With Paclitaxel Plus Carboplatin or Nab-Paclitaxel Plus 
Carboplatin Versus Paclitaxel Plus Carboplatin Alone as First-Line 
Treatment for Untreated Advanced Squamous Non-Small Cell Lung 
Cancer 
Date: 
Jan 2, 2020 
Version: 
1.0 
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SIGNATURE PAGE 
Author: 
 
               
 
                
 
 
Date:  ______________ 
 
 
 
Approval 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: ________________ 
 
 
 
 
Date: ________________ 
 
 
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TABLE OF CONTENTS 
1 
INTRODUCTION
6 
2 
STUDY OVERVIEW 
6 
3 
STUDY OBJECTIVES 
7 
3.1 
Primary Objectives 
7 
3.2 
Secondary Objectives 
8 
3.3 
Exploratory Objectives 
8 
4 
STUDY ENDPOINTS 
9 
4.1 
Primary Endpoints 
9 
4.2 
Secondary Endpoints 
9 
4.3 
Exploratory Endpoints 
9 
5 
SAMPLE SIZE CONSIDERATIONS 
10 
6 
TYPE-I-ERROR CONTROL WITH MULTIPLE ENDPOINTS 
10 
7 
INTERIM ANALYSIS 
11 
8 
STATISTICAL METHODS 
12 
8.1 
Analysis Sets 
12 
8.2 
Data Analysis General Considerations 
12 
8.2.1 
Definitions and Computations 
12 
8.2.2 
Conventions
13 
8.2.3 
Handling of Missing Data 
13 
8.2.4 
Adjustment for Covariates 
13 
8.2.5 
Multiplicity Adjustment 
13 
8.3 
Subject Characteristics 
13 
8.3.1 
Subject Disposition 
13 
8.3.2 
Protocol Deviations 
14 
8.3.3 
Demographic and Other Baseline Characteristics 
14 
8.3.4 
Disease History 
14 
8.3.5 
Prior Anticancer Drug Therapies, Radiotherapy and Surgeries 
14 
8.3.6 
Prior and Concomitant Medications 
14 
8.3.7 
Medical History 
15 
8.4 
Efficacy Analysis 
15 
8.4.1 
Primary Efficacy Endpoints 
15 
8.4.2 
Secondary Efficacy Endpoints 
16 
8.4.3 
Subgroup Analyses 
19 
8.4.4 
Exploratory Analysis 
19 
8.5 
Safety Analyses 
20 
8.5.1 
Extent of Exposure 
21 
8.5.2 
Adverse Events 
21 
8.5.3 
Laboratory Values 
23 
8.5.4 
Vital Signs 
23 
8.5.5 
Electrocardiograms (ECG) 
24 
8.5.6 
Eastern Cooperative Oncology Group (ECOG)
24 
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8.6 
Pharmacokinetic Analyses 
24 
8.7 
immunogenicity Analysis 
24 
9 
CHANGES IN THE PLANNED ANALYSIS 
25 
10 
REFERENCES
25 
10.1 
PFS censoring rules 
27 
10.2 
Health Related Quality of Life 
28 
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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Term 
ADA 
Anti-drug antibody 
ADI 
Actual dose intensity 
AE 
Adverse event 
AUC 
Area under the concentration-time curve 
BOR 
Best overall response 
CI 
Confidence interval 
CR 
Complete response 
CSR 
Clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
DOR 
Duration of response 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic case report form 
FDA 
Food and Drug Administration 
irAE 
Immune-related adverse event 
IRC 
 
Independent Review Committee 
MTD 
Maximum tolerated dose 
MedDRA 
Medical Dictionary for Regulatory Activities 
NCI 
National Cancer Institute 
ORR 
Overall response rate 
OS 
Overall survival 
PD 
Progressive disease 
PK 
Pharmacokinetic  
PFS 
Progression-free survival 
PR 
Partial response 
PS 
Performance status 
PT 
Preferred term 
RDI 
Relative dose intensity 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SOC 
System Organ Class 
TEAE 
Treatment-emergent adverse event 
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1 
INTRODUCTION 
The purpose of this statistical analysis plan (SAP) is to describe the procedures and the statistical 
methods that will be used to analyze and report results for protocol BGB-A317-307: A Phase 3, 
Multicenter, Randomized Open-Label Study to Compare the Efficacy and Safety of tislelizumab 
(BGB-A317, Anti-PD1 Antibody) Combined With Paclitaxel Plus Carboplatin or Nab-Paclitaxel 
Plus Carboplatin Versus Paclitaxel Plus Carboplatin Alone as First-Line Treatment for Untreated 
Advanced Squamous Non-Small Cell Lung Cancer. The focus of this SAP is for the planned 
primary, secondary and exploratory analysis specified in the study protocol. 
The analysis details for exploratory biomarker analyses are not described within this SAP. 
Separate analysis plans will be completed for these analyses and will be attached to the clinical 
study report. 
Reference materials for this statistical plan include the protocol amendment BGB-A317-307 
(version 3.0, dated as 16Aug2019). If the protocol is amended or updated, then appropriate 
adjustments to the SAP may be made if they are related to the planned analyses. 
The SAP described hereafter is an a priori plan. This is an open label study with a planned 
interim analysis, the SAP will be finalized and approved before interim analysis. Statistical 
programming may occur as study data accumulate in order to have analysis programs ready at 
the time the study finishes. 
All statistical analyses will be conducted using SAS® (SAS Institute, Inc., Cary, NC, USA), 
Version 9.3 or higher. 
2 
STUDY OVERVIEW 
This is an open-label, randomized, multicenter Phase 3 study designed to compare the efficacy 
and safety of tislelizumab combined with carboplatin and either paclitaxel (Arm A) or nab-
paclitaxel (Arm B) versus paclitaxel plus carboplatin alone (Arm C) as first-line treatment in 
approximately 342patients with untreated Stage IIIB or IV squamous NSCLC.  
Patients who have histologically confirmed and are untreated for their locally advanced (Stage 
IIIB) or metastatic (Stage IV) squamous NSCLC are eligible. Patients with tumors of mixed non-
small cell histology (squamous and nonsquamous) are eligible if the major histological 
component is confirmed to be squamous. Histology of squamous NSCLC will be confirmed at 
the investigator’s site. Patients with NSCLC tumors that have known EGFR-sensitizing mutation 
or ALK gene translocation are excluded but testing is not required if not known. Archival tumor 
specimens will be prospectively tested for PD-L1 expression by a central laboratory. If archived 
FFPE tissue is not sufficient for PD-L1 analysis, a fresh biopsy sample will be needed. PD-L1 
status will be characterized as PD-L1 membrane staining on TC via the Ventana SP263 assay.  
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Patients will be stratified by disease stage (IIIB versus IV), and PD-L1 expression (3 levels: < 
1% TC versus 1% to 49% TC versus  50% TC). Patients whose tissues are unevaluable for 
PD-L1 expression be included in the < 1% TC group. All patients will be randomized by a 
1:1:1 ratio to receive one of the following treatment regimens: 
x Arm A: Tislelizumab + paclitaxel + carboplatin 
x Arm B: Tislelizumab + nab-paclitaxel + carboplatin  
x Arm C: Paclitaxel + carboplatin 
Patients who are randomized into the tislelizumab plus chemotherapy arms (Arms A and B) will 
be permitted to continue tislelizumab monotherapy at the discretion of investigator if they 
experience disease progressive per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 
during chemotherapy combination phase or thereafter while receiving tislelizumab monotherapy, 
provided criteria stated in the protocol are met. Patients who are randomized into the 
chemotherapy arm (Arm C) will have the opportunity to cross over to receive tislelizumab if they 
experience radiographic disease progression on chemotherapy; that is, if disease progression per 
RECIST v1.1 has been confirmed by the independent review committee (IRC), provided criteria 
stated in the protocol are met and approval by the medical monitor has been obtained. 
The study is composed of an initial screening phase (up to 28 days), a treatment phase (until 
disease progression, intolerable toxicity, or withdrawal for other reasons), safety follow-up phase 
(around 30 days), and survival follow-up phase.  
During the study, tumor assessment will be performed at baseline, and approximately every 6 
weeks (± 7 days) for the first 6 months, every 9 weeks (± 7 days) for the remainder of Year 1, 
every 12 weeks (± 7 days) from Year 2 onwards. Tumor response will be assessed by the IRC 
and the investigator using RECIST v1.1. Patient who discontinues study treatment for reasons 
other than disease progression or death will continue to undergo tumor assessments following the 
original plan until the patient begins a subsequent anticancer treatment, experiences disease 
progression, withdraws consent, is lost to follow up, until death, or the study termination, 
whichever occurs first. 
Patients will be evaluated for safety in this study through the monitoring of all adverse events 
(AEs) and lab results, defined and graded according to National Cancer Institute Common 
Terminology Criteria for Adverse Event (NCI-CTCAE v5.0). AEs and serious adverse events 
(SAEs) will be recorded during the study and for up to 30 days after the last dose of study drug 
or until the initiation of another anticancer therapy, whichever occurs first. Immune-related AEs 
will be recorded up to 90 days after the last dose of tislelizumab, regardless of whether the 
patient starts a new anticancer therapy. 
3 
STUDY OBJECTIVES 
3.1 
PRIMARY OBJECTIVES
x To compare the PFS as assessed by the IRC per RECIST v1.1 in an Intent-to-Treat (ITT) 
analysis set between tislelizumab either combined with paclitaxel + carboplatin (Arm A) 
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or combined with nab-paclitaxel + carboplatin (Arm B) and paclitaxel + carboplatin 
alone (Arm C) in patients with untreated Stage IIIB or Stage IV squamous NSCLC. 
3.2 
SECONDARY OBJECTIVES
x To compare OS between tislelizumab combined with paclitaxel + carboplatin or nab-
paclitaxel + carboplatin and paclitaxel + carboplatin alone in the ITT Analysis set. 
x To compare ORR as assessed by the IRC and by the investigator per RECIST v1.1 
between tislelizumab combined with paclitaxel + carboplatin or nab-paclitaxel + 
carboplatin and paclitaxel + carboplatin alone. 
x To compare duration of response (DOR) as assessed by the IRC and by the investigator 
per RECIST v1.1 between tislelizumab combined with paclitaxel + carboplatin or 
carboplatin + nab-paclitaxel and paclitaxel + carboplatin alone. 
x To compare PFS as assessed by the investigator per RECIST v1.1 between tislelizumab 
combined with paclitaxel + carboplatin or nab-paclitaxel + carboplatin and paclitaxel + 
carboplatin alone in an ITT Analysis set. 
x To compare health-related quality of life (HRQoL) between tislelizumab combined with 
paclitaxel + carboplatin or carboplatin-nab-paclitaxel and paclitaxel + carboplatin alone. 
x To evaluate the safety and tolerability of tislelizumab combined with paclitaxel + 
carboplatin or nab-paclitaxel + carboplatin compared with paclitaxel + carboplatin alone. 
x To evaluate the correlation between programmed death-ligand1 (PD-L1) expression 
levels by IHC and antitumor activity of tislelizumab combined with paclitaxel + 
carboplatin or nab-paclitaxel + carboplatin. 
3.3 
EXPLORATORY OBJECTIVES 
x To compare tumor assessment outcomes (eg, DCR, time to response [TTR]) between 
tislelizumab combined with paclitaxel + carboplatin or nab-paclitaxel + carboplatin and 
paclitaxel + carboplatin alone assessed by the investigator per RECIST v1.1. 
x To assess tumor and blood-based biomarkers of tislelizumab response, resistance and 
patient prognosis. 
x To characterize the PK of tislelizumab when given in combination with paclitaxel + 
carboplatin or nab-paclitaxel + carboplatin. 
x To assess host immunogenicity to tislelizumab 
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4 
STUDY ENDPOINTS 
4.1 
PRIMARY ENDPOINTS 
x PFS as assessed by the IRC – the time from randomization to the first objectively 
documented disease progression, or death from any cause, whichever occurs first, as 
assessed by the IRC per RECIST v1.1 in the ITT Analysis set 
4.2 
SECONDARY ENDPOINTS 
x OS – the time from the date of randomization to the date of death due to any cause in an 
ITT Analysis set. 
x ORR as assessed by the IRC and investigator – the proportion of patients who had 
complete response (CR) or PR as assessed by the IRC and investigator per RECIST v1.1 
in all randomized patients with measurable disease at baseline. 
x DOR as assessed by the IRC and investigator – the time from the first occurrence of a 
documented objective response to the time of relapse, or death from any cause, 
whichever comes first, as assessed by the IRC and investigator per RECIST v1.1 in all 
randomized patients with documented objective responses. 
x PFS as assessed by the investigator – the time from randomization to the first objectively 
documented disease progression, or death from any cause, whichever occurs first, as 
assessed by the investigator per RECIST v1.1 in the ITT Analysis set. 
x HRQoL – measured using the European Organization for Research and Treatment of 
Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) and Core 30 
(EORTC QLQ-C30) as presented in patient-reported outcomes. 
x Incidence and severity of treatment-emergent AEs (TEAEs) graded according to National 
Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v5.0. 
x PD-L1 expression by IHC as a predictive biomarker for response 
4.3 
EXPLORATORY ENDPOINTS 
x DCR – the proportion of patients who had CR, PR, Non-CR/Non-PD or SD as assessed 
by the investigator per RECIST v1.1. 
x TTR – the time from randomization to the first occurrence of a documented objective 
response as assessed by the investigator per RECIST v1.1. 
x Status of exploratory biomarkers including but not limited to: PD-L1, tumor mutation 
burden (TMB), and immune-related gene expression profiling (GEP) in archival and/or 
freshly obtained tumor tissues and blood (or blood derivatives) obtained before, during, 
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or after treatment with tislelizumab or at progression, and the association with disease 
status and/or response to tislelizumab in combination with chemotherapy. 
x Summary of serum concentrations of tislelizumab. 
x Assessments of immunogenicity of tislelizumab by determining the incidence of antidrug 
antibodies (ADAs). 
5 
SAMPLE SIZE CONSIDERATIONS 
The sample size calculation is based on the number of PFS events required to demonstrate the 
PFS superiority of Arm A or Arm B to Arm C in the ITT analysis set, respectively. Exponential 
distribution is assumed for PFS. The estimates of the number of events required to demonstrate 
efficacy with regards to PFS are based on the following assumptions: 
1.
A one-sided Į of 0.025 and 80% power to detect a HR of 0.65, corresponding to an
improvement in median PFS from 6 months to 9.2 months, in the PFS of A versus C
comparison.
2.
A one-sided Į of 0.025 and 80% power to detect a HR of 0.65, corresponding to an
improvement in median PFS from 6 months to 9.2 months, in the PFS of B versus C
comparison.
3.
One planned interim analysis for both A versus C and B versus C comparisons when
~75% of targeted PFS events occurred, with Lan-DeMets O'Brien-Fleming
approximation spending function.
4.
Dropout rate of 5% per 12 months in PFS evaluation
With these assumptions, a total of approximately 173 PFS events are required for each primary 
comparison of Arm A versus Arm C or Arm B versus Arm C at final analysis for PFS. 
Assuming 342 patients are to be enrolled and randomized at a 1:1:1 ratio over a 11.5-month 
period at a steady-state enrollment rate of 40 patients per month and enrollment ramp up duration 
of six month, ie, enrollment rate of 10 patients per month from study Month 0 to Month 2, 20 
patients per month from Month 2 to Month 4, 30 patients per month from Month 4 to Month 6, 
and 40 patients per month afterwards. 
6 
TYPE-I-ERROR CONTROL WITH MULTIPLE ENDPOINTS 
Type I error will be strongly controlled at an alpha of 0.025 by using sequential testing 
procedure. Hypothesis testing for the primary endpoint of PFS (Arm A vs C followed by Arm B 
vs C) will be carried out sequentially, each at a one-sided alpha of 0.025, until the first non-
rejection. The alpha allocation algorithm is described in Figure 1 below. 
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Figure 1. Type I error control schema 
7 
INTERIM ANALYSIS 
There will be one interim efficacy analysis of PFS in each comparison performed in the ITT 
Analysis Set. For PFS endpoint, the interim efficacy analysis will be performed after 
approximately 130 PFS events (75% of the target number of approximately 173 PFS events) 
have been observed in each comparison of A versus C or B versus C.  It is estimated that it will 
take approximately 17 months to accumulate the required number of PFS events.  
An independent statistical review will be conducted to determine if the required number of 
events have occurred in two arms of A vs C or B vs. C. If the time of observing the targeted 
number of events in each comparison is different from each other, the analysis could be separate. 
The interim boundary is based on Lan DeMets O'Brien-Fleming approximation spending 
function. The interim and final analysis timing and stopping boundaries for PFS are summarized 
in Table 1 below.  The times and boundaries for interim and final analysis are based on protocol-
defined enrollment and PFS assumptions. They will be updated according to the actual PFS 
events included at interim and final analysis using Lan-DeMets spending function. 
Table 1 Analysis Timing and Stopping Boundaries for PFS in Each of the Primary Testing 
at One-Sided Į=0.025 
Type of analysis 
# Events  
Expected 
Time 
(months) 
Testing boundary 
p-value boundary
Approx. hazard ratio 
threshold 
Interim analysis 
130 
16.7 
0.0097 
0.6637 
Final analysis 
173 
23.8 
0.0221 
0.7364 
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8 
STATISTICAL METHODS 
8.1 
ANALYSIS SETS 
Intent-to-Treat (ITT) Analysis Set: includes all patients randomized to the study, and patients 
will be grouped by assigned treatment at randomization. This will be the primary analysis set for 
efficacy analysis. 
Per-Protocol analysis set (PP) includes patients in the ITT analysis set who had no important 
protocol deviations. Important protocol deviations are a subset of major protocol deviations 
impacting efficacy analysis. Criteria for exclusion from the PP will be determined and 
documented before the database lock for the primary analysis. This will be the secondary 
analysis set for efficacy analysis when there are over 10% ITT patients who had important 
protocol deviations. 
Safety Analysis Set: includes all randomized patients who received at least 1 dose of any study 
treatment, and patients will be grouped by first actual treatment arm received. This will be used 
for all safety analyses. Patients who were randomized to Arm C (paclitaxel + carboplatin) but 
received any dose of tislelizumab as first-line treatment will be included in Arm A (tislelizumab 
+ paclitaxel + carboplatin) in SAF. Patients who were randomized to Arm A (tislelizumab +
paclitaxel + carboplatin) but did not received any dose of tislelizumab will be included in Arm C
(paclitaxel + carboplatin) in SAF.
The HRQoL analysis set includes all randomized patients who received at least 1 dose of study 
drug and completed at least one HRQoL assessment. This will be the analysis set for HRQoL 
analysis.  
PK Analysis Set: includes all patients who received at least 1 dose of tislelizumab per the 
protocol, for whom any post-baseline PK data are available. 
ADA Analysis Set: includes all patients who received at least 1 dose of tislelizumab for whom 
both baseline ADA and at least 1 post-baseline ADA results are available.  
8.2 
DATA ANALYSIS GENERAL CONSIDERATIONS 
All descriptive statistics for continuous variables will be reported using mean, standard deviation 
(SD), median, 25 percentile (Q1), 75 percentile (Q3), minimum (Min), maximum (Max) and n. 
Categorical variables will be summarized as number (percentage) of patients. 
The study Table Listing Graph shells will be provided in a separate document, which will show 
the content and format of all tables, listings, and graphs in detail. 
8.2.1 
Definitions and Computations 
Baseline: Unless otherwise specified, a baseline value for ITT analysis set is defined as the last 
non-missing value collected before or at the time of randomization date, if not available, defines 
as last non-missing value collected before or at the time of first dose date. A baseline value for 
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safety analysis set is defined as the last non-missing value collected before or at the time of first 
dose date. 
Unscheduled Visits: Unscheduled measurements will not be included in by-visit table summaries 
and graphs but will contribute to best/ worst case value where required (e.g. shift table). Listings 
will include scheduled and unscheduled data. 
8.2.2 
Conventions 
Unless otherwise specified, the following conventions will be applied to all analyses: 
x 1 year = 365.25 days. Number of years is calculated as (days/365.25) rounded up to 1 
significant digit. 
x 1 month = 30.4375 days. Number of months is calculated as (days/30.4375) rounded up 
to 1 significant digit. 
x Age will be calculated as the integer part of (date of informed consent – date of birth + 
1)/365.25  
x P-values will be rounded to 4 decimal places.  P-values that round to 0.0000 will be
presented as ‘< 0.0001’ and p-values that round to 1.000 will be presented as ‘> 0.9999’.  
8.2.3 
Handling of Missing Data 
Missing data will not be imputed unless otherwise specified elsewhere in the SAP. Missing dates 
or partially missing dates will be imputed conservatively for adverse events and prior or 
concomitant medications/procedures. 
By-visit endpoints will be analyzed using observed data, unless otherwise specified. For 
observed data analyses, missing data will not be imputed and only the observed records will be 
included. 
8.2.4 
Adjustment for Covariates 
Not applicable. 
8.2.5 
Multiplicity Adjustment 
Multiplicity adjustment for hypothesis testing of PFS has been described in Section 6. No 
multiplicity adjustment for covariates. 
8.3 
SUBJECT CHARACTERISTICS 
8.3.1 
Subject Disposition 
The number (percentage) of patients randomized, treated, permanently discontinued from study 
treatment, remained on treatment, discontinued from study, and remained on study will be 
summarized in the ITT Analysis Set. The primary reasons for study treatment discontinuation 
and study discontinuation will be summarized according to the categories in the CRF. Study 
follow-up time and primary reason for screen failure will be summarized. 
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8.3.2 
Protocol Deviations 
Important protocol deviations are a subset of major protocol deviations impacting efficacy 
analysis. Criteria for major protocol deviation and important protocol deviation impacting 
efficacy will be established and patients with major and important protocol deviations will be 
identified and documented before the database lock.  
Both major protocol deviations and important protocol deviations will be summarized and listed 
by category in the ITT analysis set.   
8.3.3 
Demographic and Other Baseline Characteristics 
Demographic and other baseline characteristics will be summarized using descriptive statistics in 
the ITT Analysis Set. Continuous variables include age, weight, BMI, baseline target lesions sum 
of diameters by investigator; categorical variables include sex, age group (<65 years, 65 years), 
ECOG performance status at baseline, smoking status, and stratification factors of disease stage 
and PD-L1 expression in tumor cell. 
8.3.4 
Disease History 
The number (percentage) of patients reporting a history of disease and characteristic, as recorded 
on the CRF, will be summarized in the ITT Analysis Set. Categorical disease characteristics 
variables include disease stage, histology, baseline target lesion location, and location of distant 
metastases. Continuous disease history variables include time from initial diagnosis to study 
entry and time from advanced/metastatic disease diagnosis to study entry. 
Cancer associated symptoms at baseline will also be summarized by SOC, preferred term and 
CTCAE grade. 
8.3.5 
Prior Anticancer Drug Therapies, Radiotherapy and Surgeries 
The number and percentage of patients with prior anticancer drug therapies, time from end of last 
therapy to study entry, and type of prior anticancer drug therapy will be summarized in ITT 
Analysis Set. 
The number and percentage of patients with prior anticancer radiotherapy, anatomical site and 
time from end of last radiotherapy to study entry will be summarized in ITT Analysis Set. 
The number and percentage of patients with prior anticancer surgeries, curative intent (Yes, No), 
and time from last surgery to study entry will be summarized in ITT Analysis Set. 
8.3.6 
Prior and Concomitant Medications 
Prior and concomitant medications will be coded using the version of World Health Organization 
Drug Dictionary (WHO DD) drug codes currently in effect at Beigene at the time of database 
lock and will be further classified to the appropriate Anatomical Therapeutic Chemical (ATC) 
code.  
The number (percentage) of patients reporting prior and concomitant medications will be 
summarized by ATC medication class and WHO DD preferred term (PT)  in the Safety Analysis 
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Set. Prior medications are defined as medications that received within 30 days before 
randomization and stopped before the first dose date. Concomitant medications will be defined 
as medications that 1) started before the first dose of study drug and were continuing at the time 
of the first dose of study drug or 2) started on or after the date of the first dose of study drug up 
to 30 days after the patient’s last dose (as of the Safety Follow-up Visit). In addition, telephone 
contacts with patients should be conducted to assess irAEs and concomitant medications (if 
appropriate, ie, associated with an irAE or is a new anticancer therapy) at 60 days, and 90 days 
(± 14 days) after the last dose of study treatment, regardless of whether or not the patient starts a 
new anticancer therapy. 
8.3.7 
Medical History 
Medical History will be coded using MedDRA of the version currently in effect at BeiGene at 
the time of database lock. The number (percentage) of patients reporting a history of any medical 
condition, as recorded on the CRF, will be summarized by system organ class (SOC) and PT in 
the ITT Analysis Set.  
8.4 
EFFICACY ANALYSIS 
If not specified otherwise, efficacy analysis described in this section will be based on the ITT 
analysis set. 
8.4.1 
Primary Efficacy Endpoints 
PFS per the IRC in ITT Analysis Set 
PFS per the IRC is defined as the time from randomization to the first documented disease 
progression as assessed by the IRC with the use of RECIST v1.1, or death from any cause, 
whichever occurs first. The actual tumor assessment visit date will be used to calculate PFS. 
Patients who have a clinical determination of progression should undergo a CT/MRI, if possible, 
to correlate radiographic findings with the clinical findings. If a clinical determination of 
progression for a patient is confirmed, the date of the CT/MRI scan will be considered as the 
progression date for that patient.  
The PFS censoring rules are specified in Appendix 11.1. 
PFS per the IRC will be compared between tislelizumab in combination with paclitaxel + 
carboplatin (Arm A) and paclitaxel + carboplatin (Arm C), and between tislelizumab in 
combination with nab-paclitaxel + carboplatin (Arm B) and paclitaxel + carboplatin (Arm C). 
The two primary hypothesis tests are formed as follows: 
One-sided testing of PFS superiority of Arm A to Arm C: 
The null hypothesis to be tested is: 
H0: PFS in Arm A  PFS in Arm C 
Against the alternative hypothesis: 
Ha: PFS in Arm A > PFS in Arm C 
One-sided testing of PFS superiority of Arm B to Arm C: 
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The null hypothesis to be tested is: 
H0: PFS in Arm B  PFS in Arm C 
Against the alternative hypothesis: 
Ha: PFS in Arm B > PFS in Arm C 
The P value will be calculated from a stratified log-rank test at one-sided significance level 
Į=0.025 based on the stratification factors defined in Section 2 using the actual values from EDC 
(disease stage) and from central lab (PD-L1 expression). Kaplan Meier methodology will be used 
to estimate median or other quartiles of PFS along with its 95% confidence interval (constructed 
using Brookmeyer and Crowley method). Kaplan Meier curves will be constructed to provide a 
visual description of the PFS distribution. Event free rate at selected timepoints will be estimated 
with 95% confidence interval using Greenwood formula. Follow-up time will be estimated by 
the reverse Kaplan-Meier method. 
The HR for PFS for each comparison (ie, Arm A versus Arm C, Arm B versus Arm C) will be 
estimated using a stratified Cox proportional hazard model with Efron’s method of tie handling, 
with treatment arm as a factor and stratified by the same stratification variables used for the 
stratified log-rank test. The 95% CI for the HR will be provided. Unstratified log-rank test and 
Cox regression model will also be performed to provide p-value, HR and corresponding 95% CI. 
In order to evaluate the robustness of the PFS per IRC, we will perform possible sensitivity 
analyses with different censoring rules if the number of patients with censor reason (i.e. the 
specific situation in Appendix 11.1) is greater than or equal to 5% of patients in either of the 
comparison in the ITT analysis set. If the patient met multiple situations in Appendix 11.1, the 
censor reason will be the earliest situation. The PFS censoring rules is based on Appendix C and 
D from FDA guidance “Clinical Trial Endpoints for the Approval of Non-Small Cell Lung 
Cancer Drugs and Biologics”.  
The sensitivity analysis 1 is the same as the primary analysis except that it progressed at date of 
documented progression with protocol specified continued follow-up in all treatment arms or 
died at date of death whichever is earlier when new anticancer therapy was started. Sensitivity 
analysis 1 will be performed when >=5% of patients in either of the comparison in the ITT 
analysis set had started new anticancer therapy. 
The sensitivity analysis 2 is the same as the primary analysis except that it progressed at date of 
documented progression or died at date of death whichever is earlier after >=2 missed disease 
assessment. Sensitivity analysis 2 will be performed when >=5% of patients in either of the 
comparison in the ITT analysis set had >=2 missed disease assessment. 
When there are over 10% ITT patients who had important protocol deviations, sensitivity 
analysis 3 in PP analysis set will be implemented using primary PFS censoring rule. 
8.4.2 
Secondary Efficacy Endpoints 
Overall Survival 
OS is defined as the time from randomization to death from any cause. Data for patients who are 
not reported as having died at the time of analysis will be censored at the date last known to be 
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alive. Data for patients who do not have postbaseline information will be censored at the date of 
randomization. Similar methodologies used to evaluate PFS per the IRC will be applied to OS 
analysis. 
Progression-Free Survival per Investigator 
PFS per investigator is defined as the time from randomization to the first objectively 
documented disease progression assessed by investigator using RECIST v1.1, or death from any 
cause, whichever occurs first. PFS per the investigator will be analyzed similarly as PFS per the 
IRC. Concordance of PFS per the investigator and PFS per IRC in the ITT analysis set will also 
be assessed.  
Objective Response Rate per the IRC 
ORR (confirmation not required according to RECIST v1.1) is the proportion of patients who 
had a CR or PR as assessed by the IRC per RECIST v1.1 in all randomized patients with 
measurable disease at baseline. Patients without any postbaseline assessment will be considered 
non-responders. Patients without measurable disease at baseline will also be considered as non-
responders. The difference in ORR between Arm A versus Arm C and Arm B versus Arm C in 
the ITT Analysis Set will be evaluated using the Cochran-Mantel-Haenszel (CMH) chi-square 
test with the actual stratification factors as strata. The two-sided 95% CIs for the odds ratio and 
the difference in ORR will be calculated, as well as Clopper-Pearson 95% CIs for the ORR 
within each arm. 
In addition, the number and percentage of patients for each of the BOR categories will be 
presented.  
A waterfall plot of best percent change in sum of target lesion diameters from baseline will be 
provided for treatment arm (Arm A, Arm B and Arm C). The patients will be ordered by the 
percentage, patients with the largest percentage will be presented on the right. 
Objective Response Rate per the Investigator 
ORR (confirmation not required according to RECIST v1.1) is the proportion of patients who 
had CR or PR as assessed by the investigator per RECIST v1.1 in all randomized patients with 
measurable disease at baseline. Patients without any postbaseline assessment will be considered 
non-responders. ORR per the investigator will be analyzed similarly as ORR per the IRC. 
Duration of Response (DOR) per the IRC 
DOR per the IRC is defined for patients with an objective response as the time from the first 
documented objective response to documented disease progression as assessed by the IRC using 
RECIST v1.1, or death from any cause, whichever occurs first. Only the subset of patients who 
show a complete response or partial response will be included in the DOR analysis. Data for 
patients who are alive and who have not experienced disease progression at the time of analysis 
will be censored at the date of the last tumor assessment. If no tumor assessments were 
performed after the date of the first occurrence of the objective response (CR or PR), DOR will 
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be censored at the date of the first occurrence of the objective response. Median DOR and 
corresponding 95% CIs will be estimated using Kaplan-Meier methodology for each treatment 
arm. Comparisons of DOR per the IRC between treatment arms will be made using the log-rank 
test for descriptive purposes only.  
Duration of Response (DOR) per the Investigator 
DOR per the investigator is defined for patients with an objective response as the time from the 
first documented objective response to documented disease progression as assessed by the 
investigator using RECIST v1.1, or death from any cause, whichever occurs first. Similar 
censoring rules used for DOR per IRC will be applied for DOR per investigator. DOR per 
investigator will be analyzed similarly as DOR per IRC.  
Health-Related Quality of Life 
Analysis Method 
There is no multiplicity adjustment for the HRQoL analysis. Descriptive statistics will be used 
for all HRQoL analyses. All HRQoL analysis will be in HRQoL analysis set. Both EORTC 
QLQ-C30 and EORTC QLQ-LC13 instruments have been extensively tested for reliability and 
validity (Bergman et al, 1994; Osoba et al, 1994; Groenvold et al, 1997). Two items measuring 
overall health status and quality of life are graded on a 7-point Likert scale, while all remaining 
items are graded on a 4-point scale ranging from 1 (Not at all) to 4 (Very much).  
Compliance 
Compliance for the EORTC QLQ-C30 and EORTC QLQ-LC13 modules, defined as the 
proportion of questionnaires actual received out of the expected number (i.e, number of patients 
on treatment), in the HRQoL analysis set will be summarized for each assessment time point and 
treatment arm.   
Change from Baseline by Visit 
For each scale or item of EORTC QLQ-C30 and EORTC QLQ-LC13, summary statistics at each 
assessment time point and change from baseline will be presented by treatment arm in tables. 
Boxplot depicting the mean scores over time of global health status/quality of life will be 
provided for each treatment arm.   
Details of HRQoL scoring are specified in Appendix 11.2 according to the algorithm described 
in the EORTC QLQ-C30 and EORTC QLQ-LC13 scoring manual (Fayers 2001).  
Time to Deterioration (TTD) of HRQoL 
Time to deterioration (TTD) is defined as the time from randomization to first onset time at 
which deterioration is clinically meaningful that is confirmed at a subsequent clinically 
meaningful deterioration. The minimum important clinically difference change in symptoms of 
QLQ-C30 and QLQ-LC13 is defined as 10 points increase from baseline (Osoba et al 1998; 
King, 1996; Maringwa et al 2011). The clinically meaningful deterioration in function and global 
health status/quality of life is defined as 10 points decrease from baseline. The median TTD of 
QLQ-C30 global health status/quality of life and composite of cough, chest pain, and dyspnea in 
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the QLQ-LC13 will be calculated using Kaplan-Meier estimates, and presented with 2-sided 
95% CIs. 
PD-L1 Expression as a Predictive Biomarker for Response 
Exploratory biomarker analyses will be performed to examine the relationship between tumor 
tissue PD-L1 expression and measures of efficacy. Additionally, predictive and prognostic 
exploratory biomarkers in tumor tissue and/or blood will be examined for their association with 
disease status and clinical outcomes. These exploratory analyses will not be included in the CSR 
for this study. 
8.4.3 
Subgroup Analyses 
Subgroup analysis of primary endpoint of PFS per the IRC will be conducted to determine 
whether the treatment effect is consistent across various subgroups, and the HR estimates of PFS 
form an unstratified Cox model and its 95% CI will be estimated and plotted within each 
category of the following variables (a subgroup will not be analyzed if it includes <7% in one 
comparison of the ITT analysis set):  
x PD-L1 expression in TC ( 50% TC versus 1% to 49% TC versus < 1% TC) 
x Disease Stage (IIIB versus IV) 
x age ( 65 versus > 65 years), 
x sex (female versus male) 
x ECOG PS (0 versus 1) 
x smoking status (never versus former/current) 
x Liver metastases at baseline (Yes versus no) 
x Brain metastasis status at baseline (yes versus no) 
Forest plot of subgroup analysis in PFS per the IRC will be provided. Additional subgroup 
analysis may also be conducted per additional prognosis factors as suggested. Subgroup analysis 
of secondary endpoint may also be conducted. 
8.4.4 
Exploratory Analysis 
Disease Control Rate per the IRC and per the Investigator 
DCR is defined as the proportion of patients with objective response (CR or PR), Non-CR/Non-
PD, or stable disease maintained for  6 weeks using RECIST v1.1. Both DCR per the IRC and 
per the investigator will be analyzed. Similar methodologies for analysis of ORR will be applied 
Time to Response per the IRC and per the Investigator 
TTR per the investigator/IRC is defined for patients with an objective response as determined by 
the investigator/IRC as the time from randomization to the first occurrence of a CR or PR as 
assessed by the investigator/IRC using RECIST v1.1. Only the subset of patients who show a CR 
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or PR will be included in the TTR analysis. TTR will be summarized for descriptive purposes. 
The mean, standard error, median, and range of TTR will be provided. 
Time to first subsequent anticancer systemic therapy (TFST) 
TFST is defined for patients with the use of subsequent anticancer systemic therapy as the time 
from end of study treatment to first dose of subsequent anticancer systemic therapy. The mean, 
standard error, median, and range of TFST will be provided. 
Time to second progression-free survival per the investigator 
Analysis of progression-free survival after next line of treatment (PFS2) is defined as the time 
from randomization to second/subsequent disease progression, or death from any cause, 
whichever occurs first. Patients alive and for whom a second objective disease progression has 
not been observed will be censored at the last time known to be alive and without second 
objective disease progression. PFS2 analysis will be provided when data is mature. Similar 
methodology used to evaluate PFS per the IRC will be applied to analyze PFS2 per the 
investigator. 
Subsequent anticancer systemic therapy 
Subsequent anticancer systemic therapy will be summarized by category and PT in the ITT 
analysis set.  
Exploratory efficacy analysis of PFS/ORR in comparison of Arm B vs A 
After the success of hypothesis testing for the primary endpoint of PFS in both comparisons of A 
vs C and B vs C, hypothesis testing for B vs A will be carried out at a one-sided alpha of 0.025. 
For PFS endpoint, the P value from stratified log-rank test for descriptive purpose only, HR for 
PFS from a stratified Cox proportional hazard model and its 95% CI, median PFS along with its 
95% CI using Kaplan Meier methodology, and event free rate at selected timepoints with 95% CI 
using Greenwood formula will be provided. For ORR endpoint, the difference in ORR between 
Arm B vs A and its 95% CI, odds ratio and its 95% CI, as well as Clopper-Pearson 95% CIs for 
the ORR within each arm will be provided. 
8.5 
SAFETY ANALYSES 
All safety analyses will be performed by treatment arm based on the safety analysis set. The 
incidence of treatment-emergent adverse events (TEAEs) and SAEs will be summarized. 
Laboratory test results, vital signs, ECG, ECOG and their changes from baseline will be 
summarized using descriptive statistics (e.g., n, mean, standard deviation, median, Q1, Q3, 
minimum, maximum for continuous variables; n [%] for categorical variables).  Abnormal values 
will be flagged. 
When crossover rate (the rate among the patients who crossed over to receive at least one dose of 
tislelizumab monotherapy) is equal to or larger than 10% among the patients who actually 
randomized into Arm C, additional analysis for patients who crossed over will be provided, 
including but not limited to tislelizumab extent of exposure, overall summary of TEAE, 
concomitant medication. 
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8.5.1 
Extent of Exposure 
The study treatment dose information of each patient will be assessed by the following variables: 
x Number of treatment cycles equals to the count of cycles with tislelizumab and/or 
chemotherapy 
x Duration of exposure (weeks) is defined as: 
(date of last dose* + 21 days – date of first dose)/7, with censored by death date and 
cutoff date, without censoring when calculating actual dose intensity. 
*For chemotherapy of nab-paclitaxel (dosing at Day 1,8,15), use the date of Day 1 in the
last cycle.
x Cumulative dose (mg): the sum of all actual doses of tislelizumab/paclitaxel/nab-
paclitaxel/carboplatin, given from first to last administration 
x Actual dose intensity (ADI) in mg/cycle is defined as: 
Cumulative dose (mg) / Duration of exposure (cycles) 
x Relative dose intensity (RDI) in % is defined as: 
Where planned dose intensity for tislelizumab equals to 200 mg/cycle, for paclitaxel/nab-
paclitaxel/carboplatin equal to the sum of all planned doses/total number of cycle started 
by the patient. 
Number of cycles received by patient as a quantitative variable and by category (i.e., number (%) 
of patient receiving at least 1 cycle, at least 2 cycles etc.), duration of exposure, cumulative dose, 
ADI and RDI will be summarized by descriptive statistics. 
8.5.2 
Adverse Events 
AEs will be graded by the investigators using CTCAE v5.0. The AE verbatim descriptions 
(investigator terms from the CRF) will be classified into standardized medical terminology using 
the Medical Dictionary for Regulatory Activities (MedDRA). Adverse events will be coded to 
the MedDRA (Version 20.0 or higher) lower level term closest to the verbatim term.  The linked 
MedDRA preferred term (PT) and primary system organ class (SOC) are also captured in the 
database. 
A TEAE is defined as an AE that had an onset date or a worsening in severity from baseline 
(pre-dose) on or after the date of first dose of study drug up to 30 days following study drug 
discontinuation or initiation of new anticancer therapy, whichever comes first. For the 
tislelizumab-containing arms, the TEAE classification also applies to immune-related AEs 
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(irAE) that are recorded up to 90 days after discontinuation from tislelizumab, regardless of 
whether the patient starts a new anticancer therapy. Only those AEs that were treatment 
emergent will be included in summary tables. All AEs, treatment emergent or otherwise, will be 
presented in subject data listings. AEs that were treatment emergent for patients who crossover 
to receive tislelizumab monotherapy may be separately summarized if data allows. 
An overview of patients with at least one TEAE will be presented with the incidence of: 
x patients with any TEAE 
x patients with any TEAE with grade  3 
x patients with any serious TEAEs 
x patients with any TEAE leading to death 
x patient with any TEAE leading to permanent discontinuation of any component of study 
treatment  
x patients with any TEAE leading to treatment modification of tislelizumab and any 
component of chemotherapy 
x patients with any TEAE related to any component of study drug 
x patients with any TEAE related to tislelizumab 
x patients with any TEAE related to tislelizumab and grade  3 
x patients with any TEAE with grade  3 and related to any component of study treatment 
x patients with any serious TEAEs related to any component of study treatment 
x patients with any irTEAE 
Treatment-related AEs include those events considered by the investigator to be related to study 
treatment or with missing assessment of the causal relationship.  For patients with multiple 
occurrences of the same event will be counted only once, and the maximum grade per CTCAE 
v5.0 will be used if CTCAE grade is needed. 
If the grade is missing for one of the treatment-emergent occurrences of an adverse event, the 
maximal severity on the remaining occurrences with the same preferred term of the same patient 
will be used. If the patient has no other TEAE with the same preferred term, then impute as the 
maximum severity on all TEAE with the same preferred term; If the severity is missing for all 
the occurrences, do not impute, a “missing” category will be added in the summary table. 
The incidence of following TEAEs will be reported by SOC and PT, sorted by decreasing 
frequency of system organ class and preferred term: 
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x TEAE by maximum grade 
x TEAE leading to permanent discontinuation of any component of study treatment 
x TEAE leading to death 
x TEAE with grade  3 
x TEAE related to any component of study treatment 
x Serious TEAE 
All deaths and causes of death will be summarized by treatment arm, including those occurred 
during the study treatment period and those reported during the survival follow-up period after 
treatment completion/discontinuation. 
8.5.3 
Laboratory Values 
Laboratory results will be evaluated for selected parameters described in Table 3. 
Descriptive summary statistics (n, mean, standard deviation, median, minimum, maximum for 
continuous variables; n [%] for categorical variables) for laboratory parameters and their changes 
from baseline will be summarized by visit. 
Laboratory parameters that are graded in NCI CTCAE (v.5.0) will be summarized by shifts from 
baseline CTCAE grades to maximum post-baseline grades. In the summary of laboratory 
parameters by CTCAE grade, parameters with CTCAE grading in both high and low directions 
will be summarized separately.  
Table 3. Serum Chemistry and Hematology Laboratory Tests 
Serum Chemistry 
Hematology 
Thyroid Function 
Alanine aminotransferase (ALT) 
Hemoglobin 
Free Triiodothyronine (FT3) 
Aspartate aminotransferase (AST) 
White blood cell (WBC) count 
Free Thyroxine (FT4) 
Creatinine 
Neutrophil (Absolute) 
Thyroid Stimulating 
Hormone (TSH) 
Potassium 
Platelet count 
Sodium 
Creatine kinase (CK) 
Creatine kinase-cardiac muscle 
isoenzyme (CK-MB) 
8.5.4 
Vital Signs 
Descriptive statistics for vital sign parameters (i.e., systolic and diastolic blood pressure, pulse 
rate, temperature, and weight) and changes from baseline will be presented by visit.   
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8.5.5 
Electrocardiograms (ECG) 
ECG will be performed during screening, safety follow-up and as clinically indicated at other 
timepoints. Postbaseline abnormal QTc observations will be summarized. 
8.5.6 
Eastern Cooperative Oncology Group (ECOG) 
A shift table from baseline to worst post-baseline in ECOG performance score will be 
summarized.  
8.6 
PHARMACOKINETIC ANALYSES 
PK samples will be collected only in patients randomized to receive tislelizumab. Tislelizumab 
post-dose and Ctrough (pre-dose) will be tabulated and summarized for each cycle at which PK 
is to be measured. Descriptive statistics will include means, medians, ranges, (standard 
deviations), coefficient of variation (CV%), Geometric mean and geometric CV%, as 
appropriate.  
Additional PK analyses, including population PK analyses and exposure-response (efficacy, 
safety endpoints) analyses may be conducted as appropriate and the results from these analyses 
will be reported separately from the CSR. 
8.7 
IMMUNOGENICITY ANALYSIS 
Human anti-drug antibodies (ADA) to tislelizumab will be assessed during the study as defined 
in the protocol. 
ADA attributes: 
x 
Treatment boosted ADA is defined as ADA positive at baseline that was boosted to a 4-
fold or higher level following drug administration.  
x 
Treatment-induced ADA is defined as ADA negative at baseline and ADA positive post-
baseline.  
x 
Persistent ADA response is defined as Treatment-induced ADA detected at 2 or more 
time points during treatment or follow-up, where the first and last ADA positive samples 
are separated by 16 weeks or longer; or detected in the last time point. 
x 
Transient ADA response is defined as Treatment-induced ADA detected only at 1 time 
point during treatment or follow-up, excluding last time point; or detected at 2 or more 
timepoints during treatment or follow-up, where the first and last positive samples 
(irrespective of any negative samples in between) are separated by less than 16 weeks and 
the last time point is negative. Transient ADA is a treatment-induced response that is not 
considered persistent. 
x 
Neutralizing ADA is defined as ADA that inhibits or reduces the pharmacological 
activity. 
ADA response endpoints: 
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x ADA incidence is defined as sum of treatment-emergent ADA, which include both 
treatment-induced and treatment-boosted ADA-positive patients, as a proportion of the 
ADA evaluable population.  
x ADA prevalence is defined as proportion of all patients that are ADA positive, including 
pre-existing ADA, at any time point. 
The immunogenicity results will be summarized using descriptive statistics by the number and 
percentage of patients who develop detectable ADA.  The incidence of positive ADA and 
neutralizing ADA will be reported for evaluable patients. The effect of immunogenicity on PK, 
efficacy, and safety may be evaluated if data allow.   
9 
CHANGES IN THE PLANNED ANALYSIS 
Not applicable so far. 
10 
REFERENCES 
Brookmeyer R, Crowley J. A Confidence interval for the median survival time. Biometrics. 1982; 38: 29-
41. 
Clopper, C. and Pearson, ES. The use of confidence or fiducial limits illustrated in the case of the 
binomial, Biometrika 1934; 26: 404-413. 
Collett D. Modelling survival data in medical research. New York: Chapman & Hall; 1994. 
Common Terminology Criteria for Adverse Events (CTCAE). Version 4.0. United States Department of 
Health and Human Services, National Institutes of Health, National Cancer Institute, Washington, DC, 
USA, Nov 27, 2017. 
Eisenhauer EA, Therasse P, Bogaerts J Schwartz LH, Sargent D, Ford R, et al. New response evaluation 
criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer. 2009; 45:228-47. 
Food and Drug Administration Center for Drug Evaluation Research CDER and Center for Biologics 
Evaluation and Research. FDA Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer 
Drugs and Biologics, 2007. 
Greenwood M. “The natural duration of cancer”. Reports on Public Health and Medical Patients (London: 
Her Majesty’s Stationery Office). 1926; 33:1-26. 
Kaplan E, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958; 
53:457-81. 
Fayers PM, Aaronson NK, Bjordal K,Groenvold M, Curran D, Bottomley A, on behalf of the EORTC 
Quality of Life Group. Brussels: EORTC, EORTC QLQ-C30 Scoring Manual (3rd edition). 2001. ISBN: 
2-9300 64-22-6. 
Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M (1994) The EORTC QLQ-LC13: a modular 
supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical 
trials. EORTC Study Group on Quality of Life. Eur J Cancer 30A: 635–642. 
Osoba D, Zee B, Pater J, Warr D, Kaizer L, Latreille J (1994) Psychometric properties and responsiveness 
of the EORTC quality of Life Questionnaire (QLQ-C30) in patients with breast, ovarian and lung cancer. 
Qual Life Res 3: 353–364. 
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Groenvold M, Klee MC, Sprangers MA, Aaronson NK (1997) Validation of the EORTC QLQ-C30 
quality of life questionnaire through combined qualitative and quantitative assessment of patient-observer 
agreement. J Clin Epidemiol 50: 441–450. 
Osoba D, Rodrigues G, Myles J, Zee B, Pater J (1998) Interpreting the significance of changes in health-
related quality-of-life scores. J Clin Oncol 16: 139–144. 
King MT. The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Qual Life 
Res 1996; 5: 555–567. 
Maringwa J, Quinten C, King M, et al. Minimal clinically meaningful differences for the EORTC QLQ-
C30 and EORTC QLQ-BN20 scales in brain cancer patients. Annals of Oncology 2011; 22: 2107–2112. 
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APPENDIX 
10.1 
PFS CENSORING RULES 
Definition of Progression Date: Progression date is assigned to the first time when tumor 
progression was documented.  
The PFS derivation rules in this SAP follow the Table C1 and C2 described in Appendix C of 
Food and Drug Administration (FDA) “Guidance for Industry Clinical Trial Endpoints for the 
Approval of Non-Small Cell Lung Cancer Drugs and Biologics (2015)”.  
Censoring rules for primary and sensitivity analyses are summarized in table 2.  
Table 4 Censoring Rules for Primary and Sensitivity Analysis of PFS Per RECIST version 1.1 
No. 
Situation 
Primary Analysis 
Sensitivity Analysis 
1 
Incomplete or no baseline 
tumor assessments 
Censored at randomization date  
2 
No postbaseline tumor 
assessment and no death 
Censored at randomization date 
3 
No postbaseline tumor 
assessment and death 
Died at date of death  
4 
Progression documented 
between scheduled visits 
Progressed at date of documented progression 
5 
No progression   
Censored at date of last adequate tumor assessment with no documented 
progression 
6 
New anticancer treatment 
started 
Censored at date of last adequate 
tumor assessment before  date of new 
anticancer treatment 
Progressed at  
Date of documented progression with 
protocol specified continued follow-
up in all treatment arms or died at 
date of death whichever is earlier 
7 
Death between adequate 
assessment visits 
 Died at date of death 
8 
Death or progression after  2  
missed visit 
Censored at  date of last adequate 
tumor assessment prior to the 2 
missed tumor assessments  
Progressed at  date of documented 
progression or Died at date of death 
whichever is earlier 
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10.2 
HEALTH RELATED QUALITY OF LIFE 
The QLQ-C30 consists of thirty questions that are associated with five functional scales 
(physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea 
and vomiting), a global health status and six single items (dyspnea, insomnia, appetite loss, 
constipation, diarrhea, and financial difficulties). QLQ-C30 and QLQ-LC13 scale scores will be 
calculated as described below.  
Scoring Process 
The principle for scoring applies to all scales/scores: Raw scores are calculated as the average of 
the items that contribute to the scale.  
A linear transformation to standardize the raw scores is utilized, so that the scores are ranged 
from 0 to 100.  Increases in scores for functional domains (e.g., physical, role, social, emotional, 
etc.) are improvements while increases in scores for symptoms (e.g., fatigue, vomiting and 
nausea, diarrhea, pain, etc.) are deteriorations. 
Missing Items 
If at least half of the items for a scale are answered, then all the completed items are used to 
calculate the score.  Otherwise, the scale score is set to missing. 
In practical terms, if items I1, I2, ... In are included in a scale, the procedure is as follows: 
Raw Score 
For all scores, the raw score (RS), is the mean of the component items 
RS = (I1+I2+…+In)/n 
Derived Scale 
The derived scales are obtained from the raw scores as defined in the EORTC manual. The 
derived scales have a more intuitive interpretation: larger function scale or global health status / 
QoL are improvements while larger symptom scales (e.g., pain, nausea, etc.) are deteriorations.  
The derivation formulas are as follows. 
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Table 5 Scoring of QLQ-C30 
Scale 
Number 
of items 
Item 
range 
Item 
Numbers 
Global health status/ QoL 
 Global health status/QOL 
QL2 
2 
6 
29,30 
Functional Scales 
Physical functioning 
PF2 
5 
3 
1, 2, 3, 4, 5  
Role functioning 
RF2 
2 
3 
6, 7  
Emotional functioning 
EF 
4 
3 
21, 22, 23, 24  
Cognitive functioning 
CF 
2 
3 
20, 25  
Social functioning 
SF 
2 
3 
26, 27  
Symptom Scales/ items 
Fatigue 
FA 
3 
3 
10, 12, 18 
Nausea and vomiting 
NV 
2 
3 
14, 15 
Pain 
PA 
2 
3 
9, 19 
Dyspnoea 
DY 
1 
3 
8 
Insomnia 
SL 
1 
3 
11 
Appetite loss 
AP 
1 
3 
13 
Constipation 
CO 
1 
3 
16 
Diarrhoea 
DI 
1 
3 
17 
Financial Difficulties 
FI 
1 
3 
28 
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Table 6 Scoring of QLQ-LC13 
Scale 
Number 
of items 
Item 
range 
Item 
Numbers 
Symptom scales/items 
Dyspnoea 
LCDY 
3 
3 
3,4,5 
Coughing  
LCCO 
1 
3 
1 
Haemoptysis 
LCHA 
1 
3 
2 
Sore mouth 
LCSM 
1 
3 
6 
Dysphagia 
LCDS 
1 
3 
7 
Peripheral neuropathy 
LCPN 
1 
3 
8 
Alopecia 
LCHR 
1 
3 
9 
Pain in chest 
LCPC 
1 
3 
10 
Pain in arm or shoulder 
LCPA 
1 
3 
11 
Pain in other parts 
LCPO 
1 
3 
12 
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