A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous Non-small Cell Lung Cancer
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
2 other identifiers
interventional
334
1 country
47
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started Jul 2018
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 23, 2018
CompletedFirst Submitted
Initial submission to the registry
August 16, 2018
CompletedFirst Posted
Study publicly available on registry
September 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2023
CompletedResults Posted
Study results publicly available
November 25, 2024
CompletedFebruary 4, 2025
September 1, 2024
1.5 years
August 16, 2018
April 11, 2024
February 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Through primary analysis data cut-off date of 23JAN2020 (up to approximately 1 year and 6 months)
Secondary Outcomes (10)
Objective Response Rate (ORR) by IRC Assessment
Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
Duration of Response (DOR) by IRC Assessment
Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
Overall Survival (OS)
Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
PFS by Investigator Assessment
Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
ORR by Investigator Assessment
Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
- +5 more secondary outcomes
Study Arms (2)
Tislelizumab + Platinum + Pemetrexed
EXPERIMENTALTislelizumab 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)
Platinum + Pemetrexed
ACTIVE COMPARATORCisplatin 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
Administered intravenously
Eligibility Criteria
You may qualify if:
- Age 18-75 years old, male or female, signed informed consent form
- Advanced NSCLC diagnosed by pathological or clinical physicians
- Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
- Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1
- Participants must have no prior systemic chemotherapy for advanced or metastatic NSCLC
- Life expectancy ≥ 12 weeks
- Participants must have adequate organ function
- Male/female is willing to use a highly effective method of birth control
You may not qualify if:
- Diagnosed with NSCLC but with epidermal growth factor receptor (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
- Received any approved systemic anticancer therapy within 28 days prior to the initiation of study treatment
- Received prior treatment with EGFR inhibitors or ALK inhibitors
- Received prior therapies targeting programmed cell death protein-1 (PD-1) or programmed cell death protein ligand-1 (PD-L1)
- With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases
- Clinically significant pericardial effusion
- Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Any major surgical procedure ≤ 28 days before randomization
- Human immunodeficiency virus (HIV) infection
- Participants with untreated hepatitis B or C virus (HBV/HCV)
- Active autoimmune diseases or history of autoimmune diseases
- History of allergic reactions to chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (47)
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Chinese Pla General Hospital
Beijing, Beijing Municipality, 100853, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404000, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, 510030, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
Guizhou Cancer Hospital
Guiyang, Guizhou, 550000, China
The Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, 563000, China
Hainan General Hospital
Haikou, Hainan, 570206, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Changsha Central Hospital
Changsha, Hunan, 410004, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The First Affiliated Hospital of Soochow University Branch Shizi
Suzhou, Jiangsu, 215006, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250000, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Jinan Military General Hospital
Jinan, Shandong, 250031, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Weifang Peoples Hospital
Weifang, Shandong, 261000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650100, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Hangzhou First Peoples Hospital
Hangzhou, Zhejiang, 310006, China
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Related Publications (3)
Lu S, Wang J, Yu Y, Yu X, Hu Y, Ai X, Ma Z, Li X, Zhuang W, Liu Y, Li W, Cui J, Wang D, Liao W, Zhou J, Wang Z, Sun Y, Qiu X, Gao J, Bao Y, Liang L, Wang M. Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial. J Thorac Oncol. 2021 Sep;16(9):1512-1522. doi: 10.1016/j.jtho.2021.05.005. Epub 2021 May 23.
PMID: 34033975RESULTLu S, Wang J, Yu Y, Yu X, Hu Y, Wangjun L, Li X, Liu Y, Li W, Qu X, Bao Y, Wang M. First-Line Tislelizumab Plus Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer: PD-L1 >/= 50% Subgroup Analysis from the RATIONALE-304 Trial. Oncol Ther. 2025 Dec;13(4):1087-1104. doi: 10.1007/s40487-025-00378-8. Epub 2025 Sep 14.
PMID: 40946254DERIVEDLu S, Yu Y, Barnes G, Qiu X, Bao Y, Tang B. Examining the Impact of Tislelizumab Added to Chemotherapy on Health-Related Quality-of-Life Outcomes in Previously Untreated Patients With Nonsquamous Non-Small Cell Lung Cancer. Cancer J. 2022 Mar-Apr 01;28(2):96-104. doi: 10.1097/PPO.0000000000000583.
PMID: 35333492DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2018
First Posted
September 10, 2018
Study Start
July 23, 2018
Primary Completion
January 23, 2020
Study Completion
April 26, 2023
Last Updated
February 4, 2025
Results First Posted
November 25, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share