Clinical trial NCT03663205
Conditions: Non-Small Cell Lung Cancer
Sponsor: BeiGene
Start date: 2018-07-23; Completion date: 2023-04-26
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the efficacy and safety of tislelizumab in combination with platinum (cisplatin or carboplatin) and pemetrexed compared with platinum and pemetrexed alone as first-line treatment in participants with Stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days) arm 2: Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Interventions: intervention 1: Tislelizumab intervention 2: Cisplatin intervention 3: Carboplatin intervention 4: Pemetrexed
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously intervention 3: Administered intravenously intervention 4: Administered intravenously

Protocol documents:
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

SAP_001.pdf: 
BeiGene, (Shanghai) Co., Ltd. 
BGB-A317-304 
    (Statistical Analysis Plan) 
 
Version 1.0:  2/18/2020 
Page 1 of 29 
CONFIDENTIAL 
STATISTICAL ANALYSIS PLAN 
Study Protocol 
Number: 
BGB-A317-304 
Study Protocol 
Title: 
A Phase 3, Open-Label, Multicenter, Randomized Study to 
Investigate the Efficacy and Safety of Tislelizumab 
(BGB-A317) (Anti-PD1 Antibody) Combined With 
Platinum-Pemetrexed Versus Platinum-Pemetrexed Alone as 
First-line Treatment for Patients With Stage IIIB or IV 
Non-Squamous Non-Small Cell Lung Cancer 
Date: 
Feb 18, 2020 
Version: 
1.0 
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SIGNATURE PAGE 
Author: 
 
               
 
                
 
 
 
Approval 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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TABLE OF CONTENTS 
1 
INTRODUCTION 
6 
2 
STUDY OVERVIEW 
6 
3 
STUDY OBJECTIVES 
8 
3.1 
Primary Objectives 
8 
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 
INTERIM ANALYSIS 
10 
7 
STATISTICAL METHODS 
11 
7.1 
Analysis Sets 
11 
7.2 
Data Analysis General Considerations 
12 
7.2.1 
Definitions and Computations 
12 
7.2.2 
Conventions 
12 
7.2.3 
Handling of Missing Data 
12 
7.2.4 
Adjustment for Covariates 
13 
7.2.5 
Multiplicity Adjustment 
13 
7.3 
Patient Characteristics 
13 
7.3.1 
Patient Disposition 
13 
7.3.2 
Protocol Deviations 
13 
7.3.3 
Demographic and Other Baseline Characteristics 
13 
7.3.4 
Disease History 
13 
7.3.5 
Prior Anti-Cancer Drug Therapies, Radiotherapy and Surgeries 
14 
7.3.6 
Prior and Concomitant Medications 
14 
7.3.7 
Medical History 
14 
7.4 
Efficacy Analysis 
14 
7.4.1 
Primary Efficacy Endpoints 
14 
7.4.2 
Secondary Efficacy Endpoints 
15 
7.4.3 
Subgroup Analyses 
18 
7.4.4 
Exploratory Efficacy Endpoints 
18 
7.5 
Safety Analyses 
19 
7.5.1 
Extent of Exposure 
19 
7.5.2 
Adverse Events 
20 
7.5.3 
Laboratory Values 
21 
7.5.4 
Vital Signs 
22 
7.5.5 
Electrocardiograms (ECG) 
22 
7.5.6 
ECOG 
22 
7.6 
Pharmacokinetic Analyses 
22 
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7.7 
Immunogenicity analysis 
23 
8 
CHANGES IN THE PLANNED ANALYSIS 
23 
9 
REFERENCES 
23 
10 
APPENDIX 
26 
10.1 
PFS Censoring rules 
26 
10.2 
Health Related Quality of Life 
27 
 
 
 
 
 
 
 
 
 
 
 
 
 
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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Term 
ADA 
Anti-drug antibody 
AE 
adverse event 
CI 
confidence interval 
CR 
complete response 
CRF 
case report form 
CT 
computerized tomography 
CTCAE  
Common Terminology Criteria for Adverse Events 
Ctrough 
minimum observed plasma concentration 
DCR 
disease control rate 
DOR 
duration of response 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
IRC 
independent review committee 
KM 
Kaplan-Meier 
MedDRA® 
Medical Dictionary for Regulatory Activities 
NCI-CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse Events 
ORR 
objective response rate 
OS 
overall survival 
PD 
progressive disease 
PD1 
programmed cell death1 
PFS 
progression-free survival 
PK 
pharmacokinetics 
PR 
partial response 
PT 
preferred term 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
serious adverse events 
SAF 
Safety Analysis Set 
SAP 
statistical analysis plan 
SOC 
system organ class 
TC 
tumor cell 
TEAE 
treatment-emergent adverse event 
TMB 
tumor mutation burden 
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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-A317-304 “A Phase 3, 
Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of 
Tislelizumab (BGB-A317) (Anti-PD1 Antibody) Combined With Platinum-Pemetrexed Versus 
Platinum-Pemetrexed Alone as First-line Treatment for Patients With Stage IIIB or IV Non-
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 specific analysis variables and attached to the 
clinical study report.  
Reference materials for this statistical plan include the protocol amendment BGB-A317-304 
(version 2.0, dated 24 January 2019). If the protocol or case report forms are amended or 
updated, then appropriate adjustments to the SAP may be made if changes are related to the 
planned analyses. 
The SAP described hereafter is 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. 
2 
STUDY OVERVIEW 
Study Design 
This is an open-label, randomized, multicenter Phase 3 study designed to compare the efficacy 
and safety of tislelizumab combined with cisplatin or carboplatin pemetrexed (Arm A) and 
cisplatin or carboplatin pemetrexed alone (Arm B) as first-line treatment in approximately 
320 patients who have Stage IIIB or IV non-squamous NSCLC, whereby choice of platinum 
(cisplatin or carboplatin) will be at the investigator’s discretion. 
Patients who have not received chemotherapy with histologically confirmed non-squamous, 
locally advanced, or metastatic NSCLC (Stage IIIB or IV) are eligible. Histology of 
non-squamous NSCLC will be confirmed at the investigator’s site. Patients with known EGFR 
mutation or ALK rearrangement are ineligible for the study; for patients without documented 
tissue-based documentation of EGFR status, fresh or archival tumor tissues are required for 
EGFR mutation assessment. Archival tumor specimens will be prospectively tested for PD-L1 
expression by a central laboratory. If archived formalin-fixed paraffin-embedded (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 tumor cells (TC) via the Ventana SP263 assay. 
 
Patients will be stratified by disease stage (IIIB vs. IV), and PD-L1 expression (three levels: < 
1% TC vs. 1%–49% TC vs.  50% TC). Patients whose tissues are unevaluable for PD-L1 
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expression will be included in the < 1% TC group. All patients will be randomized by a 2:1 ratio 
to receive one of the following treatment regimens: 
Induction phase (4 to 6 cycles, Q3W): 
Arm A: tislelizumab carboplatin or cisplatin pemetrexed 
Arm B: carboplatin or cisplatin pemetrexed 
Maintenance phase (Q3W): 
Arm A: tislelizumab pemetrexed 
Arm B: pemetrexed 
Arm A patients who experience progressive disease per RECIST v1.1 during chemotherapy 
combination phase (induction or maintenance phase) or thereafter while receiving tislelizumab 
monotherapy will be permitted to continue tislelizumab monotherapy provided they meet 
additional criteria. (please see details in protocol section 3.3).  
Arm B patients who develop radiographic disease progression per RECIST v1.1 (to be confirmed 
by the independent committee) will be given the option to cross over to receive tislelizumab 
monotherapy provided they meet additional criteria. (please see details in protocol section 3.3).  
The study is composed of an initial screening phase (up to 28 days), a treatment phase (4 to 6 
cycles of induction treatment followed by maintenance therapy until disease progression, 
unacceptable toxicity, or death), safety follow-up phase (30 days ± 7 Days after last dose of 
study drug including chemotherapy-only or before the initiation of a new anticancer treatment, 
whichever occurs first ), and survival follow-up phase.  
Patients will undergo tumor assessments at baseline and every 6 weeks (± 7 days) for the first 6 
months, every 9 weeks (± 7 days) for the remaining 6 months of Year 1, and after completion of 
the Week 52 tumor assessment, tumor assessment will continue every 12 weeks (± 7 days) based 
on RECIST v1.1, regardless of dose delays to manage toxicities. Tumor response will be 
assessed by independent review committee (IRC) based on the Response Evaluation Criteria in 
Solid Tumors (RECIST) version 1.1, and by investigators based on RECIST version 1.1. Patients 
will undergo tumor assessments until radiographic disease progression per RECIST v1.1, loss of 
clinical benefit (for tislelizumab-only patients who continue treatment after radiographic disease 
progression according to RECIST v1.1), withdrawal of consent, study completion by sponsor, 
start of a new anticancer therapy, or death, whichever occurs first.   
Patients will be evaluated for adverse events (AEs) (all grades, according to National Cancer 
Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) version 5.0). All AEs 
will be recorded during the study (AEs from the time of the first dose and SAEs from 
the time of signing of informed consent) and for up to 30 days after the last dose of study drug, 
including platinum doublet chemotherapy, or until the initiation of another anticancer therapy, 
whichever occurs first. At the end of treatment, ongoing AEs considered related to study 
treatment will be followed until the event has resolved to baseline or  Grade 1, the event is 
assessed by the investigator as stable, the patient is lost to follow-up, the patient withdraws 
consent, or it has been determined that study treatment or participation is not the cause of the 
AE.  
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Immune-related AEs (irAE) should be reported for 90 days after the last dose of tislelizumab, 
regardless of whether or not the patient starts a new anticancer therapy. The investigator should 
report any SAEs that are believed to be related to tislelizumab treatment at any time after 
treatment discontinuation until patient death, withdrawal of consent, or loss to follow up, 
whichever occurs first.  
3 
STUDY OBJECTIVES 
3.1 
PRIMARY OBJECTIVES  
• 
To compare the progression-free survival (PFS) as assessed by the Independent 
Review Committee (IRC) per RECIST v1.1 in an Intent-To-Treat (ITT) analysis set 
between tislelizumab combined with platinum-pemetrexed and platinum-pemetrexed 
alone in chemotherapy-naive patients with Stage IIIB or Stage IV (as classified 
according to American Joint Committee Cancer 7th Edition of Cancer Staging 
Manual) non-squamous, non-small cell lung cancer (NSCLC). 
3.2 
SECONDARY OBJECTIVES  
• 
To compare overall response rate (ORR) as assessed by the IRC and by the 
investigator per RECIST v1.1 between tislelizumab combined with platinum-
pemetrexed and platinum-pemetrexed alone. 
• 
To compare duration of response (DOR) as assessed by the IRC and by the 
investigator per RECIST v1.1 between tislelizumab combined with platinum-
pemetrexed and platinum-pemetrexed alone. 
• 
To compare overall survival (OS) between tislelizumab combined with platinum-
pemetrexed and platinum-pemetrexed alone in the ITT analysis set 
• 
To compare PFS as assessed by the investigator per RECIST v1.1 between 
tislelizumab combined with platinum-pemetrexed and platinum-pemetrexed alone in 
the ITT analysis set. 
• 
To compare health-related quality of life (HRQoL) between tislelizumab combined 
with platinum-pemetrexed and platinum-pemetrexed alone. 
• 
To evaluate the safety and tolerability of tislelizumab combined with platinum-
pemetrexed compared with platinum-pemetrexed alone. 
• 
To evaluate the correlation between programmed death-ligand1 (PD-L1) expression 
levels by immunohistochemistry (IHC) and antitumor activity of tislelizumab 
combined with platinum-pemetrexed. 
3.3 
EXPLORATORY OBJECTIVES 
• 
To compare tumor assessment outcomes (eg, DCR, TTR) between tislelizumab 
combined with platinum-pemetrexed and platinum-pemetrexed alone as assessed by 
the investigator per RECIST v1.1. 
• 
To assess tumor and blood biomarkers of tislelizumab response, resistance, and 
patient prognosis. 
• 
To characterize the pharmacokinetics of tislelizumab when given in combination with 
platinum-pemetrexed. 
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• 
To assess host immunogenicity to tislelizumab. 
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 
• 
ORR as assessed by the IRC–the proportion of patients who had complete response 
(CR) or partial response (PR) as assessed by the IRC per RECIST v1.1 in the ITT 
analysis set. 
• 
DOR as assessed by the IRC–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 per RECIST v1.1 in the ITT analysis set with 
documented objective responses. 
• 
OS – the time from the date of randomization until date of death from any cause in 
the ITT analysis set. 
• 
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 determined by the investigator per RECIST v1.1 in the ITT analysis 
set.  
• 
ORR as assessed by the investigator–the proportion of patients who had CR or PR as 
determined by the investigator per RECIST v1.1 in the ITT analysis set. 
• 
DOR as assessed by the 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 determined by the investigator per RECIST v1.1 in the ITT 
analysis set with documented objective responses. 
• 
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 
• 
Incidence and severity of treatment-emergent AEs (TEAEs) graded according to 
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-
CTCAE), v5.0. 
• 
PD-L1 expression by IHC as a predictive biomarker for response. 
4.3 
EXPLORATORY ENDPOINTS 
• 
DCR–the proportion of patients who had a CR, partial response (PR), Non-CR/Non-
PD, or stable disease as assessed by the investigator per RECIST v1.1.  
• 
TTR–the time from randomization to the first occurrence of a documented objective 
response as assessed by the investigator per RECIST v1.1.  
• 
Status of exploratory biomarkers, including but not limited to: PD-L1, tumor 
mutation burden (TMB), and immune-related gene expression profiling (GEP) in 
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archival and/or freshly obtained tumor tissues and blood (or blood derivatives) 
obtained before, during, or after treatment with tislelizumab or at progression and the 
association with disease status and/or response to tislelizumab in combination with 
chemotherapy. 
• 
Summary of serum concentrations of tislelizumab. 
• 
Assessments of immunogenicity of tislelizumab by determining the incidence of 
antidrug antibodies (ADAs). 
5 
SAMPLE SIZE CONSIDERATIONS 
The sample size calculation was based on the number of events required to demonstrate the PFS 
superiority of Arm A to Arm B in the ITT analysis set. 
 
The estimates of the number of events required to demonstrate efficacy about PFS in the primary 
comparisons are based on the following assumptions: 
 
1. Median PFS of 7 months in Arm B with exponential distribution assumption. 
2. At a one-sided Į of 0.025, 85% power to detect an HR of 0.65, corresponding to an 
improvement in median PFS from 7 months to 10.8 months, in the ITT analysis set. 
3. Randomization ratio of 2:1. 
4. One interim analysis of PFS planned in the ITT analysis set when approximately 71% of 
total PFS events occurred, with Lan-DeMets’ approximation to O’Brien-Fleming 
boundary (O’Brien et al, 1979). 
 
With these assumptions, a total of 215 PFS events is required for the ITT analysis set for the PFS 
final analysis. Assuming 320 patients are to be enrolled over an 8-month period at a constant 
enrollment rate, the PFS final analysis will occur approximately 19.2 months after the first 
patient is randomized. 
6 
INTERIM ANALYSIS 
There will be one interim efficacy analysis of PFS performed in the ITT analysis set. The interim 
efficacy analysis of PFS will be performed when approximately 153 PFS events (71% of the 
targeted number of 215 PFS events) are observed in the ITT analysis set. It is estimated that it 
will take approximately 12.8 months to observe 153 PFS events. 
 
The interim boundary for PFS is based on the Lan-DeMets approximation to O’Brien-Fleming 
boundary. The interim and final analysis timing and stopping boundaries based on approximately 
153 interim PFS events are summarized in Table 1, and the exact time of each analysis will 
depend on actual number of events occurred. Meanwhile, the boundaries as presented in the 
Table 1 will be updated based on actual PFS events number at interim and final analyses 
according to the pre-specified spending function.  
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Table 1. Analysis Timing and Stopping Boundary for PFS in the ITT Analysis Set (overall 
one-sided hypothesis testing at Į = 0.025) 
Type of 
Analysis 
Number of 
Events 
Expected 
Time 
(Months) 
Testing Boundary 
P-value 
Boundary 
Approx. HR 
Threshold 
Interim analysis  
153 
12.8 
0.0078 
0.660 
Final analysis  
215 
19.2 
0.0226 
0.748 
7 
STATISTICAL METHODS 
7.1 
ANALYSIS SETS 
The ITT analysis set includes all randomized patients. Patients will be analyzed according to 
their randomized treatment arms. 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. 
 
The Safety analysis set (SAF) includes all randomized patients who received at least 1 dose of 
study drug; it will be the analysis set for the safety analyses. For first line treatment, patients who 
randomized to arm B (carboplatin or cisplatin + pemetrexed) but took any dose of Tislelizumab 
will be included in arm tislelizumab carboplatin or cisplatin pemetrexed in SAF. Patients 
who randomized to arm A (tislelizumab + carboplatin or cisplatin + pemetrexed) but did not take 
any dose of Tislelizumab will be included in carboplatin or cisplatin pemetrexed 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.  
 
The PK analysis set includes all patients who receive at least 1 dose of tislelizumab per the 
protocol, for whom any post-baseline PK data are available. 
 
The immunogenicity (ADA) analysis set includes all patients who received at least 1 complete 
dose of tislelizumab for whom both baseline ADA and at least 1 post-baseline ADA results are 
available. 
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7.2 
DATA ANALYSIS GENERAL CONSIDERATIONS 
Statistical programming and analyses will be performed using SAS® (SAS Institute, Inc., Cary, 
NC, USA), version 9.3 or higher, and/or other validated statistical software as required. 
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. 
7.2.1 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, defined 
as last non-missing value collected before or at the time of first dose date. A baseline value for 
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. 
7.2.2 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’.   
7.2.3 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. 
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7.2.4 Adjustment for Covariates 
No adjustments for covariates are planned for primary, secondary and exploratory analyses in the 
study. 
7.2.5 Multiplicity Adjustment 
Multiplicity adjustment of interim analysis has been described in section 6. 
7.3 
PATIENT CHARACTERISTICS 
7.3.1 Patient Disposition 
The number and 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.   
7.3.2 Protocol Deviations 
Important protocol deviations are a subset of major protocol deviations impacting efficacy 
analysis. Criteria for major protocol derivation 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 derivation and important protocol deviations will be summarized and listed 
by category in the ITT analysis set.   
7.3.3 Demographic and Other Baseline Characteristics 
Demographic and other baseline characteristics will be summarized in the ITT analysis set using 
descriptive statistics.   
Continuous demographic and baseline variables include age, BMI (in kg/m2) and body weight 
(in kg); 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.  
7.3.4 Disease History 
Lung cancer disease history characteristics will be summarized in the ITT analysis set.  
Categorical disease characteristics variables include disease stage, histology, and baseline target 
lesion location. 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. 
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7.3.5 Prior Anti-Cancer Drug Therapies, Radiotherapy and Surgeries 
The number and percentage of patients with prior anti-cancer drug therapies, time from end of 
last therapy to study entry, and type of prior anti-cancer drug therapy will be summarized in the 
ITT analysis set. 
The number and percentage of patients with any prior anti-cancer radiotherapy, anatomical site, 
time from end of last radiotherapy to study entry will be summarized in the ITT analysis set.  
The number and percentage of patients with any prior anti-cancer surgeries, curative intent (Yes, 
No), and time from last surgery to study entry will be summarized in the ITT analysis set.   
7.3.6 Prior and Concomitant Medications 
Prior and concomitant medications will be coded using the World Health Organization Drug 
Dictionary (WHO DD) of the version 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 and percentage of patients who took prior and concomitant medications will be 
summarized respectively by ATC medication class and WHO DD preferred term (PT) in the 
safety analysis set. Prior medications will be defined as medications that received within 30 days 
before randomization and stopped before the day of first dose of study drug. 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 and 90 days (± 14 days) after the last dose of study drugs regardless of whether or 
not the patient starts a new anticancer therapy. 
7.3.7 Medical History 
Medical history will be coded using MedDRA version currently in effect at BeiGene at the time 
of database lock. The number and percentage of patients reporting a history of any medical 
condition will be summarized by System Organ Class (SOC) and PT in the ITT analysis set. 
7.4 
EFFICACY ANALYSIS 
If not specified otherwise, efficacy analyses described in this section will be based on the ITT 
analysis set.  
7.4.1 Primary Efficacy Endpoints 
The primary efficacy endpoint is PFS per the IRC.  
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. 
  
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The PFS censoring rules are specified in Appendix 10.1.  
 
PFS per the IRC will be compared between tislelizumab with platinum-pemetrexed (Arm A) and 
platinum-pemetrexed alone (Arm B), the null and alternative hypotheses are set as follows: 
H0: PFS in Arm A  PFS in Arm B 
Ha: PFS in Arm A > PFS in Arm B 
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 method will be used to estimate median and other quartiles of PFS along with its 
95% confidence interval (constructed using Brookmeyer and Crowley method). Kaplan-Meier 
survival probabilities for each arm will be plotted over time. 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. 
 
A stratified Cox proportional hazard model with Efron's method of tie handling will be used to 
assess the magnitude of the treatment difference (i.e., hazard ratio) between the treatment arms, 
with the same stratification variables used for the stratified log-rank test. The hazard ratio and its 
95% confidence interval from the stratified Cox model with Efron's method of tie handling and 
with a single treatment covariate will be reported.  
 
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 10.1) is greater than or equal to 5% of patients in the ITT analysis 
set. If the patient met multiple situations in Appendix 10.1, the censor reason will be the earliest 
situation.   
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.  
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 tumor 
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. 
 
7.4.2  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 post-baseline 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 the investigator 
PFS per the investigator is defined as the time from randomization to the first objectively 
documented disease progression, or death from any cause, whichever occurs first, as determined 
by the investigator per RECIST v1.1 in the ITT analysis set. Similar methodology used to 
evaluate PFS per the IRC will be applied to analysis of PFS per the investigator. Concordance of 
PFS per the investigator and PFS per IRC in the ITT analysis set will also be assessed.  
 
Overall 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 ITT analysis set. Patients without 
any post-baseline assessment will be considered non-responders. Patients without measurable 
disease at baseline will also be considered as non-responders. The difference in ORR between 
arms 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. 
 
A waterfall plot of best percent change in sum of target lesion diameters from baseline per IRC 
will be provided by treatment arm. The patients in each arm will be ordered by the percentage, 
patients with the largest percentage will be presented on the right.  
 
Overall response rate per the investigator 
ORR (confirmation not required according to RECIST v1.1) is the proportion of patients 
who had a CR or PR as determined by the investigator per RECIST v1.1 in ITT analysis set. 
Patients without any post-baseline assessment will be considered non-responders. Similar 
methodology used to evaluate ORR per the IRC will be applied to analysis of ORR per the 
investigator. 
 
Duration of response 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 
the 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 
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. 
 
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Duration of response 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 determined by the 
investigator using the RECIST v1.1, or death from any cause, whichever occurs first. 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 
be censored at the date of the first occurrence of the objective response. Similar methodology 
used to evaluate DOR per the IRC will be applied to analysis of DOR per the investigator. 
 
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 was clinically meaningful that was confirmed at a subsequent clinically meaningful 
deterioration. The minimum clinically meaningful important difference on the QLQ-C30 and 
LC13 is at least 10 points (Osoba et al, 1998 King, 1996; Maringwa et al 2011). The clinically 
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meaningful deterioration in symptoms of QLQ-C30 and QLQ-LC13 is defined as 10 points 
increase from baseline. And 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 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. 
7.4.3  Subgroup Analyses 
Subgroup analysis of primary endpoint of PFS per the IRC will be conducted to determine if the 
treatment effect is consistent across various subgroups, the HR estimates of PFS from an 
unstratified Cox model and its 95% CI will be estimated and plotted within each category of the 
following classification variables (a subgroup will not be analyzed if it includes <10% of the ITT 
analysis set):  
x Age (< 65 year versus  65years) 
x Sex (female versus male) 
x ECOG Performance Status (0 versus 1) 
x Smoking status (Former or Current versus Never) 
x Disease stage (IIIB versus IV) 
x Brain metastases at baseline (Yes versus no)  
x Liver metastases at baseline (Yes versus no) 
x PD-L1 expression in TC ( 50% TC versus 1%-49% TC versus < 1% TC) 
x ALK rearrangement (Negative versus unknown) 
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 endpoints may also be conducted.  
7.4.4 Exploratory Efficacy Endpoints 
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 the 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 is defined for patients with an objective response as determined by the 
investigator as the time from randomization to the first occurrence of a CR or PR as determined 
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by the investigator using the RECIST v1.1. TTR per the IRC is defined for patients with an 
objective response as determined by the IRC as the time from randomization to the first 
occurrence of a CR or PR as determined by the IRC using the RECIST v1.1. Only the subset of 
patients who show a complete response or partial response will be included in the TTR analysis. 
TTR will be summarized for descriptive purposes. 
The mean, SD, median, and range of TTR will be provided.  
Time to first subsequent anti-cancer systemic therapy (TFST) 
TFST is defined for patients with the use of subsequent anti-cancer systemic therapy as the time 
from end of study treatment to first dose of subsequent anti-cancer systemic therapy. The mean, 
SD, median, and range of TFST will be provided. 
 
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 anti-cancer systemic therapy 
Subsequent anti-cancer systemic therapy will be summarized by category and PT in the ITT 
analysis set.  
7.5 
SAFETY ANALYSES 
All safety analyses will be based on safety analysis set.  The incidence of treatment-emergent 
adverse events (TEAEs, Section 7.5.2) and SAEs will be summarized. Laboratory test results, 
vital signs, ECG, ECOG and their changes from baseline will be summarized using descriptive 
statistics Abnormal values will be flagged. 
Safety analyses of patients who crossover to receive tislelizumab monotherapy may be separately 
summarized if data allows. 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 B, additional analysis for patients who crossed over 
will be provided, including but not limited to tislelizumab extent of exposure, overall summary 
of TEAE and concomitant medication. 
7.5.1 Extent of Exposure 
Extent of exposure to each study drug will be summarized descriptively by the following 
variables: 
x Number of treatment cycles  
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x Duration of exposure (weeks) is defined as: 
(date of last dose of study drug + 21 days – date of first dose of study drug)/7, with 
censored by death date and cutoff date, without censoring when calculating actual dose 
intensity.   
x Cumulative dose (mg): the sum of all actual dose of study drug, given from first to last 
administration 
x Actual dose intensity (ADI) in mg/cycle is defined as  
Cumulative dose (mg) received by a patient / Duration of exposure (cycles) 
x Relative dose intensity (RDI) in % is defined as: 
 
Where planned dose intensity (PDI) of tislelizumab equals to 200mg/cycle and for other 
chemotherapy: 
PDI = 
 , where K = total number of cycles patient has received  
7.5.2 Adverse Events  
AEs will be graded by the investigators using CTCAE version 5.0 and coded using the Medical 
Dictionary for Regulatory Activities (MedDRA) currently in effect at BeiGene at the time of 
database lock. 
A treatment-emergent AE (TEAE) is defined as an AE that had an onset date or a worsening in 
severity from baseline (pre-treatment) on or after the first dose of study drug up to 30 days after 
the last dose of study drug or initiation of new anticancer therapy, whichever occurs first. For 
tislelizumab arm, the TEAE classification also applies to irAEs that are recorded up to 90 days 
after the last dose of 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 patient data listings. AEs that were 
treatment emergent for patients who crossover to receive tislelizumab monotherapy may be 
separately summarized if data allows.  
 
An overview table of patients with at least one TEAE will be presented with the incidence of: 
x patients with any TEAE 
x patients with any  grade 3 TEAE  
x patients with any serious TEAEs 
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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 related to any component of study treatment 
x patients with any TEAE related to tislelizumab 
x patients with any TEAE related to tislelizumab and  grade 3  
x patients with any TEAE  grade 3 and related to any component of study treatment 
x patients with any serious TEAEs and related to any component of study treatment 
x patients with any potential irTEAE 
 
Treatment-related TEAEs include those events considered by the investigator to be related 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 the grade is missing for one of the treatment-emergent occurrences of an adverse event, the 
maximal grade 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 grade on all TEAE with the same preferred term; If the grade 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 the SOC and PT: 
x TEAE by maximum grade 
x TEAE leading to permanent discontinuation of any component of study treatment  
x TEAE leading to death 
x  grade 3 TEAE   
x TEAE related to any component of study treatment  
x Serious TEAE   
 
All deaths and cause of death will be summarized, including those occurred during the study 
treatment period and those reported during the survival follow-up period after treatment 
discontinuation. 
7.5.3 Laboratory Values 
Descriptive summary statistics (eg, n, mean, standard deviation, median, minimum, maximum 
for continuous variables; n [%] for categorical variables) for selected laboratory parameters 
described in Table 2 and their changes from baseline will be summarized by visit.  
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Selected laboratory parameters that are graded in NCI-CTCAE v5.0 will be summarized by shift 
from baseline CTCAE grades to maximum post-baseline grades, parameters with CTCAE 
grading in both high and low directions will be summarized separately. 
Patient data listings of selected laboratory parameters will be provided. 
Table 2 
Clinical 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  
Potassium 
Platelet count 
Hormone (TSH) 
Sodium 
 
 
Creatine kinase (CK) 
Creatine kinase-cardiac muscle 
isoenzyme (CK-MB) 
 
 
 
7.5.4 Vital Signs 
 Descriptive statistics for vital sign parameters (systolic and diastolic blood pressure, pulse rate, 
body temperature) and weight and changes from baseline will be summarized by visit.   
7.5.5 Electrocardiograms (ECG) 
ECG will be performed during baseline and multiple time post-baseline points (refer the time 
points to the protocol study assessments and procedures schedule). Postbaseline abnormal QTc 
observations will be summarized.  
7.5.6 ECOG 
A shift table from baseline to worst post-baseline in ECOG performance score will be 
summarized.  
7.6 
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 these 
concentrations are collected. 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. 
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7.7 
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: 
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. 
8 
CHANGES IN THE PLANNED ANALYSIS 
Not applicable.  
9 
REFERENCES 
Brookmeyer R, Crowley J. A Confidence interval for the median survival time. Biometrics. 1982; 
38: 29-41. 
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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, May 28, 2009. 
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. 
Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.  
Washington, DC: United States Food and Drug Administration; 2007. 
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. 
 
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. 
 
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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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10 
 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)”, which includes 
documented progression only.  
Censoring rules for primary and sensitivity analyses are summarized in Table 3.  
Table 3 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 Wumor assessment 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 4 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 5 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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