Comparison of Efficacy and Safety of Tislelizumab (BGB-A317) Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With Non-Small Cell Lung Cancer (NSCLC)
RATIONALE-303
A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti-PD1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen
3 other identifiers
interventional
805
10 countries
121
Brief Summary
The purpose of this study is to show that tislelizumab will improve overall survival in participants with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or third-line treatment setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Nov 2017
Typical duration for phase_3 nonsmall-cell-lung-cancer
121 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
November 27, 2017
CompletedStudy Start
First participant enrolled
November 30, 2017
CompletedFirst Posted
Study publicly available on registry
December 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2024
CompletedResults Posted
Study results publicly available
February 10, 2025
CompletedFebruary 10, 2025
January 1, 2025
3.6 years
November 27, 2017
January 16, 2025
January 16, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Survival (OS) in All Participants (Co-primary Endpoint)
OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization.
From randomization to the data cutoff date of 10 August 2020; up to 32.4 months
Overall Survival (OS) in Programmed Cell Death Protein Ligand-1 (PD-L1)-Positive Participants (Co-primary Endpoint)
OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization.
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Secondary Outcomes (10)
Objective Response Rate (ORR) in All Participants
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Objective Response Rate in PD-L1-Positive Participants
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Duration of Response (DOR) for All Responders
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Duration of Response (DOR) in PD-L1-Positive Responders
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Progression-free Survival (PFS) in All Participants
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
- +5 more secondary outcomes
Study Arms (2)
Tislelizumab
EXPERIMENTALParticipants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Docetaxel
ACTIVE COMPARATORParticipants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Interventions
Tislelizumab administered by intravenous (IV) infusion
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years.
- Signed Informed Consent Form.
- Histologically confirmed locally advanced or metastatic (Stage IIIB or IV) NSCLC of either squamous or non-squamous histology types with disease progression during or following treatment with at least one platinum-containing regimen, but no more than 2 lines of systemic therapy.
- Participants must be able to provide fresh or archival tumor tissues for central assessment of PD-L1 expression in tumor cells. Participants with non-squamous histology must provide evidence of not harboring sensitizing epidermal growth factor (EGFR) mutation tested by a histology-based method.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Adequate hematologic and end-organ function.
- Expected life span \> 12 weeks.
- Willing to be compliance with birth control requirement during pre-specified study participating period
You may not qualify if:
- Prior therapies of docetaxel or treatment targeting programmed cell death protein 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte associated protein 4 (CTLA-4).
- Harboring EGFR sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation.
- Unresolved side effects of Grade 2 and above from prior anti-cancer therapies, except for adverse events (AEs) not constituting a likely safety risk (e.g. alopecia, rash, pigmentation, specific lab abnormalities).
- History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).
- History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
- With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Severe chronic or active infection requiring systemic treatment.
- Known human immunodeficiency virus (HIV) infection, participants with untreated chronic hepatitis B, active vaccination treatment.
- Insufficient cardiac functions and other underlying unfavorable cardiovascular conditions.
- Prior allogeneic stem cell transplantation or organ transplantation.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- With conditions requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications.
- With severe underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse that may affect the explanation of drug toxicity or AEs or result in impaired compliance with study conduct.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (121)
Hospital de Amor Barretos
Barretos, 14784-400, Brazil
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, 29308-020, Brazil
Hospital Haroldo Juacaba Instituto Do Cancer Do Ceara
Fortaleza, 60430-230, Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia
Ijuí, 98700-000, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, 17210-120, Brazil
Hospital Bruno Born
Lajeado, 95900-000, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, 99010-080, Brazil
Hgb Hospital Giovanni Battista Mae de Deus Center
Porto Alegre, 90470-340, Brazil
Hospital Sao Lucas Da Pucrs
Porto Alegre, 90610-000, Brazil
Hospital Nossa Senhora Da Conceicao
Porto Alegre, 91350-200, Brazil
Hospital de Clinicas de Porto Alegre
Porto AlegreRS, 900350-903, Brazil
Inca Instituto Nacional de Cancer
Rio de Janeiro, 20231-050, Brazil
Nob Nucleo de Oncologia Da Bahia
Salvador, 40170-110, Brazil
Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo André, 09060-650, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, 15090-000, Brazil
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, 01246-000, Brazil
Umhat Deva Maria, Eood
Burgas, 8000, Bulgaria
Mhat Dobrich, Ad
Dobrich, 9300, Bulgaria
Mhat Dr Tota Venkova, Ad
Gabrovo, 5300, Bulgaria
Complex Oncology Center Rousse Eood
Rousse, 7000, Bulgaria
Mhat For Womens Health Nadezhda, Ood
Sofia, 1330, Bulgaria
Acibadem City Clinic Mhat Tokuda Ead
Sofia, 1407, Bulgaria
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
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, 510030, China
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, 510120, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, 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
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Changsha Central Hospital
Changsha, Hunan, 410004, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Nantong Tumor Hospital Branch North
Nantong, Jiangsu, 226000, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000, China
Jiangxi Province Cancer Hospital
Nanchang, Jiangxi, 330029, China
Jilin Cancer Hospital
Changchun, Jilin, 130021, 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
Jinan Central Hospital
Jinan, Shandong, 250013, China
Linyi Cancer Hospital
Linyi, Shandong, 276001, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Tianjin Union Medical Center (Nankai University Affiliated Hospital)
Tianjin, Tianjin Municipality, 300121, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650100, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Branch Oncology Hospital
Kaunas, 45427, Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, 50103, Lithuania
National Cancer Institute
Vilnius, 8660, Lithuania
Investigacion Onco Farmaceutica (Oncotech)
La Paz, 23040, Mexico
Fundacion Rodolfo Padilla Padilla, Ac
León, 37000, Mexico
Health Pharma Professional Research Sa de Cv
Mexico City, 03100, Mexico
Medica Sur
México, 14050, Mexico
Accelerium S de Rl de Cv
Monterrey, 64000, Mexico
Centro de Investigacion Clinica Chapultepec Sa de Cv
Morelia, 58260, Mexico
Oaxaca Site Management Organization Sc
Oaxaca City, 68000, Mexico
Auckland City Hospital
Auckland, 1023, New Zealand
Waikato Hospital
Hamilton Waikato, 3204, New Zealand
Tauranga Hospital
Tauranga, 3112, New Zealand
Szpital Specjalistyczny Brzeziny
Brzeziny, 95-060, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Centrum Terapii Wspolczesnej Jm Jasnorzewska Sp Komandytowo Akcyjna
Lodz, 90-242, Poland
Salve Medica Sp Z Oo, Sp Komandytowa
Lodz, 91-211, Poland
Zespol Gruzlicy I Chorob Pluc W Olsztynie Oddz Onkologii Z Pododdz Chemioterapii Nowotworow Puc
Olsztyn, 10-357, Poland
Mazowiecki Szpital Specjalistyczny W Ostrolece Im Dr Jozefa Psarskiego
Ostrołęka, 07-410, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
Otwock, 05-400, Poland
Izerskie Centrum Pulmonologii I Chemioterapii Izer Med Spolka Z Oo
Szklarska Porba, 58-580, Poland
Centrum Onkologii Instytut Im M Sklodowskiej Curie
Warsaw, 02-034, Poland
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk, Arkhangelskaya oblast, 163045, Russia
Irkutsk Regional Oncology Dispensary
Irkutsk, Irkutiskaya Oblast', 664035, Russia
Fsbi of Higher Educationogarev Mordovia State University
Saransk, Mordoviya, Respublika, 430005, Russia
N N Blokhin Russian Cancer Research Center Konstantin Laktionov
Moscow, Moscow, 115478, Russia
Fsbi Russian Scientific Center of Radiology and Nuclear Medicine of the Moh of the Rf
Moscow, Moscow, 117837, Russia
Vitamed Llc
Moscow, Moscow, 121309, Russia
Bih of Omsk Region Clinical Oncology Dispensary
Omsk, Omsk Oblast, 644013, Russia
Sbei Hpe Ryazan State Medical University Na Academician Ip Pavlov of the Moh of the Rf
Ryazan, Ryazan Oblast, 390026, Russia
Private Medical Institution Evromedservis
Pushkin, Sankt-Peterburg, 7042, Russia
Pavlov First Saint Petersburg State Medical University
SaintPetersburg, Sankt-Peterburg, 197022, Russia
Llc Center of Palliative Medicine Devita
SaintPetersburg, Sankt-Peterburg, 197183, Russia
Fsbi Clinical Research and Practical Center For Specialized Medical Care (Oncology)
SanktPetersburg, Sankt-Peterburg, 197758, Russia
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
Volgograd, Volgograd Oblast, 400138, Russia
Fsbi National Medical Research Center For Oncology Na Nn Petrov of the Moh of the Rf
SaintPetersburg, 197758, Russia
Fakultna Nemocnica S Poliklinikou Fd Roosevelta
Banská Bystrica, 97409, Slovakia
Nemocnica S Poliklinikou Sv Jakuba, No Bardejov
Bardejov, 8501, Slovakia
Narodny Onkologicky Ustav
Bratislava, 83310, Slovakia
Vychodoslovensky Onkologicky Ustav, As
Košice, 4191, Slovakia
Nemocnica S Poliklinikou Stefana Kukuru Michalovce, As
Michalovce, 7101, Slovakia
Fakultna Nemocnica S Poliklinikou Nove Zamky
Nové Zámky, 94002, Slovakia
Nemocnica Na Okraji Mesta, No
Partizánske, 95814, Slovakia
Poko Poprad Sro
Poprad, 5801, Slovakia
Acibadem Adana Hospital
Adana, 01130, Turkey (Türkiye)
Hacettepe University
Ankara, 6100, Turkey (Türkiye)
Nonu Universitesi Tip Fakultesi
Battalgazi, 44280, Turkey (Türkiye)
Tr Trakya University Health Research and Application Center (Hospital)
Edirne, 22030, Turkey (Türkiye)
Bakirkoy Dr Sadi Konuk Teaching and Research Hospital
Istanbul, 34147, Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Ehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
Necmettin Erbakan University Selcuklu Faculty of Medicine
Meram, 42090, Turkey (Türkiye)
Iu C, Clinical Research Excellence Application and Research Center
Stanbul, 34098, Turkey (Türkiye)
Namik Kemal University
Tekirdağ, 59100, Turkey (Türkiye)
Related Publications (2)
Zhou C, Huang D, Fan Y, Yu X, Liu Y, Shu Y, Ma Z, Wang Z, Cheng Y, Wang J, Hu S, Liu Z, Poddubskaya E, Disel U, Akopov A, Dvorkin M, Zheng W, Ma Y, Wang Y, Li S, Yu C, Rivalland G. Tislelizumab Versus Docetaxel in Patients With Previously Treated Advanced NSCLC (RATIONALE-303): A Phase 3, Open-Label, Randomized Controlled Trial. J Thorac Oncol. 2023 Jan;18(1):93-105. doi: 10.1016/j.jtho.2022.09.217. Epub 2022 Sep 29.
PMID: 36184068RESULTHuang D, Zhou C, Barnes G, Ma Y, Li S, Zhan L, Tang B. The effects of tislelizumab treatment on the health-related quality of life of patients with advanced non-small cell lung cancer. Cancer Med. 2023 Aug;12(16):17403-17412. doi: 10.1002/cam4.6361. Epub 2023 Aug 17.
PMID: 37587845RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- PRINCIPAL INVESTIGATOR
Caicun Zhou, PhD
Shanghai Pulmonary Hospital, Shanghai, China
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
November 27, 2017
First Posted
December 2, 2017
Study Start
November 30, 2017
Primary Completion
July 15, 2021
Study Completion
January 18, 2024
Last Updated
February 10, 2025
Results First Posted
February 10, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share