NCT04005716CompletedPhase 3
Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Etoposide With or Without Tislelizumab (BGB-A317) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 28 Feb 2025
Brief summary (registry, in English)
This Phase 3 study was a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy of tislelizumab in combination with either cisplatin or carboplatin and etoposide (Arm A), compared to placebo combined with either cisplatin or carboplatin and etoposide (Arm B), as a first-line treatment for participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 457 (actual)
- First submitted
- 1 Jul 2019
- Start date
- 22 Jul 2019
- Primary completion date
- 19 Apr 2023
- Lead sponsor
- BeiGene
- Diseases
- Lung cancer
- NCT number
- NCT04005716
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 457
- From 22 Jul 2019 to the primary completion date, 19 Apr 2023
- 50 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Was administered a live vaccine ≤ 4 weeks before randomization;
- Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before randomization;
- Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to randomization, including but not limited to tuberculosis infection;
- Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized at the time of randomization;
Other illness
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
- Participant with untreated hepatitis B virus (HBV)/hepatitis C virus (HCV), or a known history of HIV infection;
Lab values
- Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
Other
- Clinically significant pericardial effusion, or Clinically uncontrolled pleural effusion
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- Age≥18 years old, male or female, signed Informed Consent Form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed ES-SCLC
- No prior systemic treatment for ES-SCLC
- Adequate hematologic and end organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University International Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Changsha Central Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Sichuan Cancer Hospital and Institute Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Daping Hospital, Third Military Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Cancer Center of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Provincial Peoples Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Affiliated Hospital of Guilin Medical University Coordinator of this site? Confirm its status | Guilin | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| The Second Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| The First Hospital of Lanzhou University Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Nanjing Chest Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| General Hospital of Eastern Theater Command Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Tumor Hospital Affiliated to Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| The Peoples Hospital of Guangxi Zhuang Autonomous Region Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| The Affiliated Hospital of Qingdao University Branch South Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Liaoning Cancer Hospital and Institute Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Affiliated Cancer Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Union Hospital of Tongji Medical College Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuhan Central Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| The First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Shaanxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Yantai Yuhuangding Hospital Coordinator of this site? Confirm its status | Yantai | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
Related publications
- First-Line Tislelizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Extensive-Stage SCLC: A Long-Term Survival and Programmed Death-Ligand 1 Subgroup Analysis From the Randomized, Phase 3 RATIONALE-312 Trial.J Thorac Oncol · 2026 · PMID 41796863
- Tislelizumab plus platinum and etoposide versus placebo plus platinum and etoposide as first-line treatment for extensive-stage small-cell lung cancer: patient-reported outcomes in the RATIONALE-312 trial.Curr Med Res Opin · 2025 · PMID 41614649
This page is information, not medical advice. Discuss any trial with your doctor.