AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3RATIONALE-303NCT03358875

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)

A Phase 3 study testing Tislelizumab and Docetaxel in people with Non-small Cell Lung Cancer, run by BeiGene at 121 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Tislelizumab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
805 participants
Where
121 sitesin 10 countries
Study dates
30 Nov 2017to 18 Jan 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

121 sites in 10 countries.

121 sites in 10 countries

China44 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Chinese Pla General Hospital

    Beijing, Beijing Municipality, 100853

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Changsha Central Hospital

    Changsha, Hunan, 410004

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071

  • Daping Hospital, Third Military Medical University

    Chongqing, Chongqing Municipality, 400042

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong, 510030

  • Guangzhou Institute of Respiratory Disease

    Guangzhou, Guangdong, 510120

  • Hainan General Hospital

    Haikou, Hainan, 570206

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang University College of Medicine Second Affiliated Hospital

    Hangzhou, Zhejiang, 310009

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100

  • Linyi Cancer Hospital

    Linyi, Shandong, 276001

  • Jiangxi Province Cancer Hospital

    Nanchang, Jiangxi, 330029

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Nantong Tumor Hospital Branch North

    Nantong, Jiangsu, 226000

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515031

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Tianjin Union Medical Center (Nankai University Affiliated Hospital)

    Tianjin, Tianjin Municipality, 300121

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • The Affiliated Hospital of Zunyi Medical College

    Zunyi, Guizhou, 563000

Other trials in China

Brazil16 sites

  • Hospital de Amor Barretos

    Barretos, 14784-400

  • Hospital Evangelico de Cachoeiro de Itapemirim

    Cachoeiro de Itapemirim, 29308-020

  • Hospital Haroldo Juacaba Instituto Do Cancer Do Ceara

    Fortaleza, 60430-230

  • Oncosite Centro de Pesquisa Clinica Em Oncologia

    Ijuí, 98700-000

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17210-120

  • Hospital Bruno Born

    Lajeado, 95900-000

  • Hospital Sao Vicente de Paulo

    Passo Fundo, 99010-080

  • Hgb Hospital Giovanni Battista Mae de Deus Center

    Porto Alegre, 90470-340

  • Hospital Sao Lucas Da Pucrs

    Porto Alegre, 90610-000

  • Hospital Nossa Senhora Da Conceicao

    Porto Alegre, 91350-200

  • Hospital de Clinicas de Porto Alegre

    Porto AlegreRS, 900350-903

  • Inca Instituto Nacional de Cancer

    Rio de Janeiro, 20231-050

  • Nob Nucleo de Oncologia Da Bahia

    Salvador, 40170-110

  • Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia

    Santo André, 09060-650

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    São José do Rio Preto, 15090-000

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    São Paulo, 01246-000

Other trials in Brazil

Russia14 sites

  • Arkhangelsk Regional Clinical Oncological Dispensary

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • Irkutsk Regional Oncology Dispensary

    Irkutsk, Irkutiskaya Oblast', 664035

  • N N Blokhin Russian Cancer Research Center Konstantin Laktionov

    Moscow, Moscow, 115478

  • Fsbi Russian Scientific Center of Radiology and Nuclear Medicine of the Moh of the Rf

    Moscow, Moscow, 117837

  • Vitamed Llc

    Moscow, Moscow, 121309

  • Bih of Omsk Region Clinical Oncology Dispensary

    Omsk, Omsk Oblast, 644013

  • Private Medical Institution Evromedservis

    Pushkin, Sankt-Peterburg, 7042

  • Sbei Hpe Ryazan State Medical University Na Academician Ip Pavlov of the Moh of the Rf

    Ryazan, Ryazan Oblast, 390026

  • Pavlov First Saint Petersburg State Medical University

    SaintPetersburg, Sankt-Peterburg, 197022

  • Llc Center of Palliative Medicine Devita

    SaintPetersburg, Sankt-Peterburg, 197183

  • Fsbi National Medical Research Center For Oncology Na Nn Petrov of the Moh of the Rf

    SaintPetersburg, 197758

  • Fsbi Clinical Research and Practical Center For Specialized Medical Care (Oncology)

    SanktPetersburg, Sankt-Peterburg, 197758

  • Fsbi of Higher Educationogarev Mordovia State University

    Saransk, Mordoviya, Respublika, 430005

  • State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary

    Volgograd, Volgograd Oblast, 400138

Other trials in Russia

Turkey (Türkiye)11 sites

  • Acibadem Adana Hospital

    Adana, 01130

  • Hacettepe University

    Ankara, 6100

  • Nonu Universitesi Tip Fakultesi

    Battalgazi, 44280

  • Tr Trakya University Health Research and Application Center (Hospital)

    Edirne, 22030

  • Bakirkoy Dr Sadi Konuk Teaching and Research Hospital

    Istanbul, 34147

  • Goztepe Prof Dr Suleyman Yalcin Ehir Hastanesi

    Istanbul, 34722

  • Ege University Medical Faculty

    Izmir, 35100

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

  • Necmettin Erbakan University Selcuklu Faculty of Medicine

    Meram, 42090

  • Iu C, Clinical Research Excellence Application and Research Center

    Stanbul, 34098

  • Namik Kemal University

    Tekirdağ, 59100

Other trials in Turkey (Türkiye)

Poland9 sites

  • Szpital Specjalistyczny Brzeziny

    Brzeziny, 95-060

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Centrum Terapii Wspolczesnej Jm Jasnorzewska Sp Komandytowo Akcyjna

    Lodz, 90-242

  • Salve Medica Sp Z Oo, Sp Komandytowa

    Lodz, 91-211

  • Zespol Gruzlicy I Chorob Pluc W Olsztynie Oddz Onkologii Z Pododdz Chemioterapii Nowotworow Puc

    Olsztyn, 10-357

  • Mazowiecki Szpital Specjalistyczny W Ostrolece Im Dr Jozefa Psarskiego

    Ostrołęka, 07-410

  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy

    Otwock, 05-400

  • Izerskie Centrum Pulmonologii I Chemioterapii Izer Med Spolka Z Oo

    Szklarska Porba, 58-580

  • Centrum Onkologii Instytut Im M Sklodowskiej Curie

    Warsaw, 02-034

Other trials in Poland

Slovakia8 sites

  • Fakultna Nemocnica S Poliklinikou Fd Roosevelta

    Banská Bystrica, 97409

  • Nemocnica S Poliklinikou Sv Jakuba, No Bardejov

    Bardejov, 8501

  • Narodny Onkologicky Ustav

    Bratislava, 83310

  • Vychodoslovensky Onkologicky Ustav, As

    Košice, 4191

  • Nemocnica S Poliklinikou Stefana Kukuru Michalovce, As

    Michalovce, 7101

  • Fakultna Nemocnica S Poliklinikou Nove Zamky

    Nové Zámky, 94002

  • Nemocnica Na Okraji Mesta, No

    Partizánske, 95814

  • Poko Poprad Sro

    Poprad, 5801

Other trials in Slovakia

Mexico7 sites

  • Investigacion Onco Farmaceutica (Oncotech)

    La Paz, 23040

  • Fundacion Rodolfo Padilla Padilla, Ac

    León, 37000

  • Medica Sur

    México, 14050

  • Health Pharma Professional Research Sa de Cv

    Mexico City, 03100

  • Accelerium S de Rl de Cv

    Monterrey, 64000

  • Centro de Investigacion Clinica Chapultepec Sa de Cv

    Morelia, 58260

  • Oaxaca Site Management Organization Sc

    Oaxaca City, 68000

Other trials in Mexico

Bulgaria6 sites

  • Umhat Deva Maria, Eood

    Burgas, 8000

  • Mhat Dobrich, Ad

    Dobrich, 9300

  • Mhat Dr Tota Venkova, Ad

    Gabrovo, 5300

  • Complex Oncology Center Rousse Eood

    Rousse, 7000

  • Mhat For Womens Health Nadezhda, Ood

    Sofia, 1330

  • Acibadem City Clinic Mhat Tokuda Ead

    Sofia, 1407

Other trials in Bulgaria

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics Branch Oncology Hospital

    Kaunas, 45427

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, 50103

  • National Cancer Institute

    Vilnius, 8660

Other trials in Lithuania

New Zealand3 sites

  • Auckland City Hospital

    Auckland, 1023

  • Waikato Hospital

    Hamilton Waikato, 3204

  • Tauranga Hospital

    Tauranga, 3112

Other trials in New Zealand

About this study

Official title: 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.

Read the 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.

Being tested
Tislelizumab, Docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    Also called BGB-A317, TEVIMBRA®

    Tislelizumab administered by intravenous (IV) infusion

  • DocetaxelDrug

    Docetaxel administered as an IV infusion over 1 hour

Study groups in NCT03358875
Study groupRoleWhat they receive
TislelizumabExperimentalParticipants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Receives: Drug: Tislelizumab
DocetaxelActive comparatorParticipants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization to the data cutoff date of 10 August 2020; up to 32.4 months

  2. 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.

    Measured: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

Secondary outcomes (10)

  1. 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.

    Measured: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

  2. 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.

    Measured: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

  3. 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.

    Measured: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

  4. 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.

    Measured: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

  5. 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.

    Measured: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

  6. 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.

    Measured: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

  7. 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.

    Measured: Baseline and Cycle 6 (each cycle was 3 weeks)

  8. 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.

    Measured: Baseline and Cycle 6 (each cycle was 3 weeks)

  9. 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.

    Measured: Baseline and Cycle 6 (each cycle was 3 weeks)

  10. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2017
  2. Study start30 Nov 2017
  3. Primary completion15 Jul 2021
  4. Study completion18 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
805 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03358875
Sponsor's protocol ID
BGB-A317-303
Other IDs
2018-000245-39, CTR20171112, 2018
Acronym
RATIONALE-303
Status last verified
Jan 2025
First submitted
27 Nov 2017
Last updated
10 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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.

    PubMed 36184068

  • 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.

    PubMed 37587845

  • de Marchi P, Fan Y, Ma Z, Wang Y, Bao Y, Zheng W, Naicker K, Zhou C. RATIONALE-303: Long-Term Outcomes of Tislelizumab in Previously Treated Advanced/Metastatic NSCLC. JTO Clin Res Rep. 2026 Jun 1;7(8):101028. doi: 10.1016/j.jtocrr.2026.101028. eCollection 2026 Aug.

    PubMed 42529140

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab and Docetaxel in people with Non-small Cell Lung Cancer, run by BeiGene at 121 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in China, Brazil, Russia, Turkey (Türkiye), Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in All Participants (Co-primary Endpoint) (time frame: From randomization to the data cutoff date of 10 August 2020; up to 32.4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03358875, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in