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

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Tislelizumab; Drug: Docetaxel

Detailed Description

This is a randomized, open-label, multicenter Phase 3 study in adult participants with histologically confirmed, locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.

• Study Type: Interventional
• Enrollment (Actual): 805
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Barretos, Brazil, 14784-400
    • Hospital de Amor Barretos
  • Cachoeiro de Itapemirim, Brazil, 29308-020
    • Hospital Evangelico de Cachoeiro de Itapemirim
  • Fortaleza, Brazil, 60430-230
    • Hospital Haroldo Juacaba Instituto Do Cancer Do Ceara
  • Ijui, Brazil, 98700-000
    • ONCOSITE Centro de Pesquisa Clínica Em Oncologia
  • Jau, Brazil, 17210-120
    • Fundação Doutor Amaral Carvalho
  • Lajeado, Brazil, 95900-000
    • Hospital Bruno Born
  • Passo Fundo, Brazil, 99010-080
    • Hospital São Vicente de Paulo
  • Porto Alegre, Brazil, 90610-000
    • Hospital São Lucas da PUCRS
  • Porto Alegre, Brazil, 91350-200
    • Hospital Nossa Senhora da Conceição
  • Porto Alegre, Brazil, 90470-340
    • Hgb Hospital Giovanni Battista Mae de Deus Center
  • Porto AlegreRS, Brazil, 900350-903
    • Hospital de Clinicas de Porto Alegre
  • Rio de Janeiro, Brazil, 20231-050
    • Inca Instituto Nacional de Cancer
  • Salvador, Brazil, 40170-110
    • Nob Nucleo de Oncologia Da Bahia
  • Santo Andre, Brazil, 09060-650
    • Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
  • Sao Jose do Rio Preto, Brazil, 15090-000
    • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • Sao Paulo, Brazil, 01246-000
    • ICESP Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
• Bulgaria
  • Burgas, Bulgaria, 8000
    • Umhat Deva Maria, Eood
  • Dobrich, Bulgaria, 9300
    • Mhat Dobrich, Ad
  • Gabrovo, Bulgaria, 5300
    • Mhat Dr Tota Venkova, Ad
  • Rousse, Bulgaria, 7000
    • Complex Oncology Center Rousse Eood
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Mhat Tokuda Ead
  • Sofia, Bulgaria, 1330
    • Mhat For Womens Health Nadezhda, Ood
• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • The First Affiliated Hospital of Anhui Medical University
    • Hefei, Anhui, China, 230000
      • Anhui Provincial Hospital
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital
    • Beijing, Beijing, China, 101149
      • Beijing Chest Hospital, Capital Medical University
    • Beijing, Beijing, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Daping Hospital, Third Military Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangzhou Institute of Respiratory Disease
    • Guangzhou, Guangdong, China, 510030
      • Cancer Center of Guangzhou Medical University
    • Shantou, Guangdong, China, 515031
      • Cancer Hospital of Shantou University Medical College
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • The Affiliated Hospital of Zunyi Medical College
  • Hainan
    • Haikou, Hainan, China, 570206
      • Hainan General Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410004
      • Changsha Central Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Nantong, Jiangsu, China, 226000
      • Nantong Tumor Hospital Branch North
    • Suzhou, Jiangsu, China, 215000
      • The Second Affiliated Hospital of Soochow University
    • Xuzhou, Jiangsu, China, 221000
      • Xuzhou Central Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Province Cancer Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130021
      • Jilin Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital and Institute
  • Shaanxi
    • Xian, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xiân Jiaotong University
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
    • Linyi, Shandong, China, 276001
      • LinYi Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Shanghai Pulmonary Hospital
    • Shanghai, Shanghai, China, 200025
      • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
  • Sichuan
    • Chengdu, Sichuan, China, 610071
      • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
    • Tianjin, Tianjin, China, 300121
      • Tianjin Union Medical Center (Nankai University Affiliated Hospital)
  • Xinjiang
    • Urumqi, Xinjiang, China, 830054
      • The First Affiliated Hospital of Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650100
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310003
      • The first Affiliated Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310009
      • Zhejiang University College of Medicine Second Affiliated Hospital
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University
• Lithuania
  • Kaunas, Lithuania, 45427
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics Branch Oncology Hospital
  • Kaunas, Lithuania, 50103
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Vilnius, Lithuania, 8660
    • National Cancer Institute
• Mexico
  • Ciudad de Mexico, Mexico, 03100
    • Health Pharma Professional Research Sa de Cv
  • La Paz, Mexico, 23040
    • Investigacion Onco Farmaceutica (Oncotech)
  • Leon, Mexico, 37000
    • Fundacion Rodolfo Padilla Padilla, Ac
  • Mexico, Mexico, 14050
    • Médica Sur
  • Monterrey, Mexico, 64000
    • Accelerium S de RL de CV
  • Morelia, Mexico, 58260
    • Centro de Investigacion Clinica Chapultepec Sa de Cv
  • Oaxaca, Mexico, 68000
    • Oaxaca Site Management Organization SC
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
  • Hamilton Waikato, New Zealand, 3204
    • Waikato Hospital
  • Tauranga, New Zealand, 3112
    • Tauranga Hospital
• Poland
  • Brzeziny, Poland, 95-060
    • Szpital Specjalistyczny Brzeziny
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne
  • Lodz, Poland, 90-242
    • Centrum Terapii Wspolczesnej Jm Jasnorzewska Sp Komandytowo Akcyjna
  • Lodz, Poland, 91-211
    • Salve Medica Sp Z Oo, Sp Komandytowa
  • Olsztyn, Poland, 10-357
    • Zespol Gruzlicy I Chorob Pluc W Olsztynie Oddz Onkologii Z Pododdz Chemioterapii Nowotworow Puc
  • Ostroleka, Poland, 07-410
    • Mazowiecki Szpital Specjalistyczny W Ostrolece Im Dr Jozefa Psarskiego
  • Otwock, Poland, 05-400
    • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
  • Szklarska Porba, Poland, 58-580
    • Izerskie Centrum Pulmonologii I Chemioterapii Izer Med Spolka Z Oo
  • Warszawa, Poland, 02-034
    • Centrum Onkologii Instytut Im M Sklodowskiej Curie
• Russian Federation
  • SaintPetersburg, Russian Federation, 197758
    • Fsbi National Medical Research Center For Oncology Na Nn Petrov of the Moh of the Rf
  • Arkhangel'skaya Oblast'
    • Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation, 163045
      • Arkhangelsk Regional Clinical Oncological Dispensary
  • Irkutiskaya Oblast'
    • Irkutsk, Irkutiskaya Oblast', Russian Federation, 664035
      • Irkutsk Regional Oncology Dispensary
  • Mordoviya, Respublika
    • Saransk, Mordoviya, Respublika, Russian Federation, 430005
      • Fsbi of Higher Educationogarev Mordovia State University
  • Moskva
    • Moscow, Moskva, Russian Federation, 121309
      • VitaMed LLC
    • Moscow, Moskva, Russian Federation, 115478
      • N N Blokhin Russian Cancer Research Center Konstantin Laktionov
    • Moscow, Moskva, Russian Federation, 117837
      • Fsbi Russian Scientific Center of Radiology and Nuclear Medicine of the Moh of the Rf
  • Omskaya Oblast'
    • Omsk, Omskaya Oblast', Russian Federation, 644013
      • Bih of Omsk Region Clinical Oncology Dispensary
  • Ryazanskaya Oblast'
    • Ryazan, Ryazanskaya Oblast', Russian Federation, 390026
      • Sbei Hpe Ryazan State Medical University Na Academician Ip Pavlov of the Moh of the Rf
  • Sankt-Peterburg
    • Pushkin, Sankt-Peterburg, Russian Federation, 7042
      • Private Medical Institution Evromedservis
    • SaintPetersburg, Sankt-Peterburg, Russian Federation, 197022
      • Pavlov First Saint Petersburg State Medical University
    • SaintPetersburg, Sankt-Peterburg, Russian Federation, 197183
      • Llc Center of Palliative Medicine Devita
    • SanktPetersburg, Sankt-Peterburg, Russian Federation, 197758
      • Fsbi Clinical Research and Practical Center For Specialized Medical Care (Oncology)
  • Volgogradskaya Oblast'
    • Volgograd, Volgogradskaya Oblast', Russian Federation, 400138
      • State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary
• Slovakia
  • Banska Bystrica, Slovakia, 97409
    • Fakultna Nemocnica S Poliklinikou Fd Roosevelta
  • Bardejov, Slovakia, 8501
    • Nemocnica S Poliklinikou Sv Jakuba, No Bardejov
  • Bratislava, Slovakia, 83310
    • Narodny Onkologicky Ustav
  • Kosice, Slovakia, 4191
    • Vychodoslovensky Onkologicky Ustav, As
  • Michalovce, Slovakia, 7101
    • Nemocnica s poliklinikou Stefana Kukuru Michalovce, as
  • Nove Zamky, Slovakia, 94002
    • Fakultna nemocnica s poliklinikou Nove Zamky
  • Partizanske, Slovakia, 95814
    • Nemocnica Na Okraji Mesta, No
  • Poprad, Slovakia, 5801
    • Poko Poprad Sro
• Turkey
  • Adana, Turkey, 01130
    • Acibadem Adana Hospital
  • Ankara, Turkey, 6100
    • Hacettepe University
  • Battalgazi, Turkey, 44280
    • Nonu Universitesi Tip Fakultesi
  • Edirne, Turkey, 22030
    • Tr Trakya University Health Research and Application Center (Hospital)
  • Istanbul, Turkey, 34147
    • Bakirkoy Dr Sadi Konuk Teaching and Research Hospital
  • Istanbul, Turkey, 34722
    • Goztepe Prof Dr Suleyman Yalcin Ehir Hastanesi
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty
  • Kocaeli, Turkey, 41380
    • Kocaeli Universitesi Tip Fakultesi
  • Meram, Turkey, 42090
    • Necmettin Erbakan University Selcuklu Faculty of Medicine
  • Stanbul, Turkey, 34098
    • Iu C, Clinical Research Excellence Application and Research Center
  • Tekirdag, Turkey, 59100
    • Namik Kemal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Age ≥ 18 years.
2. Signed Informed Consent Form.
3. 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.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
6. Adequate hematologic and end-organ function.
7. Expected life span > 12 weeks.
8. Willing to be compliance with birth control requirement during pre-specified study participating period

Key Exclusion Criteria:

1. 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).
2. Harboring EGFR sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation.
3. 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).
4. History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).
5. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
6. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
7. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
8. Severe chronic or active infection requiring systemic treatment.
9. Known human immunodeficiency virus (HIV) infection, participants with untreated chronic hepatitis B, active vaccination treatment.
10. Insufficient cardiac functions and other underlying unfavorable cardiovascular conditions.
11. Prior allogeneic stem cell transplantation or organ transplantation.
12. Active autoimmune diseases or history of autoimmune diseases that may relapse.
13. With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications.
14. 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab; Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Drug: Tislelizumab; Tislelizumab administered by intravenous (IV) infusion; Other Names: BGB-A317; TEVIMBRA®
Active Comparator: Docetaxel; Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.	Drug: Docetaxel; Docetaxel administered as an IV infusion over 1 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) in All Participants	Objective response rate is defined as the percentage of participants who had a complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the chest, abdomen, and pelvis. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions and no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions.	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	Objective response rate is defined as the percentage of participants who had a complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the chest, abdomen, and pelvis. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions and no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions.	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	DoR was defined as the time from the first documented objective response to documented disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.	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	DoR was defined as the time from the first documented objective response to documented disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.	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	PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.	From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Progression-free Survival in PD-L1 Positive Participants	PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.	From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) Score	The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and two global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS/QoL score indicates better quality of life.	Baseline and Cycle 6 (each cycle was 3 weeks)
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 Items (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scores	The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores indicate an improvement in symptoms.	Baseline and Cycle 6 (each cycle was 3 weeks)
Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)	The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.	Baseline and Cycle 6 (each cycle was 3 weeks)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. The investigator assessed the severity of each AE and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 as defined below: Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living.; Grade 3: Severe or medically significant but not immediately life threatening. hospitalization or prolongation of hospitalization indicated; disabling; limiting selfcare activities of daily living.; Grade 4: Life threatening consequences; urgent intervention indicated.; Grade 5: Death related to AE.	From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 18 January 2024 (up to approximately 63 months)

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Principal Investigator: Caicun Zhou, PHD, Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

General Publications

• 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.
• Huang 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): January 18, 2024

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Tislelizumab
• Other Study ID Numbers: BGB-A317-303; 2018-000245-39 (EudraCT Number); CTR20171112 (Registry Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No