A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer
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
2 other identifiers
interventional
360
1 country
43
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).
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
43 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
First Submitted
Initial submission to the registry
July 3, 2018
CompletedFirst Posted
Study publicly available on registry
July 20, 2018
CompletedStudy Start
First participant enrolled
July 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2023
CompletedResults Posted
Study results publicly available
October 17, 2023
CompletedOctober 26, 2024
October 1, 2024
2.2 years
July 3, 2018
September 19, 2023
October 23, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019
PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first
Through primary analysis data cut-off date of 06DEC2019 (up to approximately 1 year and 4 months)
PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020
PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first
Through primary analysis data cut-off date of 30SEP2020 (up to approximately 2 years and 2 months)
Secondary Outcomes (10)
Overall Survival (OS)
Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)
Objective Response Rate (ORR) by IRC Assessment
Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)
ORR by Investigator Assessment
Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)
Duration of Response (DOR) by IRC Assessment
Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)
DOR by Investigator Assessment
Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)
- +5 more secondary outcomes
Study Arms (3)
Tislelizumab + Paclitaxel + Carboplatin
EXPERIMENTALTislelizumab 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)
Tislelizumab + Nab-paclitaxel + Carboplatin
EXPERIMENTALTislelizumab 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)
Paclitaxel + Carboplatin
ACTIVE COMPARATORPaclitaxel 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
Administered intravenously as described
Administered intravenously as described
Administered intravenously as described
Administered intravenously as described
Eligibility Criteria
You may qualify if:
- Age 18-75 years old, male or female, and signed informed consent form (ICF)
- Advanced NSCLC diagnosed by pathological or clinical physicians
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
- Participants must have ≥ 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Must be treatment-naive for locally advanced or metastatic squamous 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 receptors (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
- Received any approved systemic anticancer therapy
- Received prior treatment with EGFR inhibitors or ALK inhibitors
- Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
- With history of interstitial lung disease
- Clinically significant pericardial effusion
- Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Any major surgical procedure before randomization
- Human immunodeficiency virus infection
- Untreated hepatitis B virus (HBV)/hepatitis C virus (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 (43)
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Chinese Pla General Hospital
Beijing, Beijing Municipality, 100853, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Southwest Hospital
Chongqing, Chongqing Municipality, 400038, 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
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
The Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, 563000, 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
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210002, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, 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
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
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Hangzhou First Peoples Hospital
Hangzhou, Zhejiang, 310006, 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)
Wang J, Lu S, Yu X, Hu Y, Sun Y, Wang Z, Zhao J, Yu Y, Hu C, Yang K, Feng G, Ying K, Zhuang W, Zhou J, Wu J, Leaw SJ, Zhang J, Lin X, Liang L, Yang N. Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):709-717. doi: 10.1001/jamaoncol.2021.0366.
PMID: 33792623BACKGROUNDWang, J, S. Lu, et al. Randomized Phase III Study of Tislelizumab plus Chemotherapy versus Chemotherapy Alone as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer (Sq-NSCLC): RATIONALE-307 Updated Analysis. IOTECH Abstract, Vol. 16 Supplement 1, Dec. 2022. doi.org/10.1016/j.iotech.2022.100244.
BACKGROUNDDuan J, Zhang Y, Chen R, Liang L, Huo Y, Lu S, Zhao J, Hu C, Sun Y, Yang K, Chen M, Yu Y, Ying J, Huang R, Ma X, Leaw S, Bai F, Shen Z, Cai S, Gao D, Wang J, Wang Z. Tumor-immune microenvironment and NRF2 associate with clinical efficacy of PD-1 blockade combined with chemotherapy in lung squamous cell carcinoma. Cell Rep Med. 2023 Dec 19;4(12):101302. doi: 10.1016/j.xcrm.2023.101302. Epub 2023 Dec 4.
PMID: 38052215DERIVED
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
July 3, 2018
First Posted
July 20, 2018
Study Start
July 30, 2018
Primary Completion
September 30, 2020
Study Completion
April 28, 2023
Last Updated
October 26, 2024
Results First Posted
October 17, 2023
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share