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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

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
China-Japan Friendship Hospital
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Peking University International Hospital
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BeijingChinaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Chinese PLA General Hospital
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BeijingChinaUnknown status
Peking Union Medical College Hospital
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BeijingChinaUnknown status
Beijing Hospital
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BeijingChinaUnknown status
Jilin Cancer Hospital
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ChangchunChinaUnknown status
Changsha Central Hospital
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ChangshaChinaUnknown status
Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
Sichuan Cancer Hospital and Institute
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ChengduChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Daping Hospital, Third Military Medical University
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ChongqingChinaUnknown status
Fujian Cancer Hospital
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FuzhouChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
The First Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaUnknown status
Cancer Center of Guangzhou Medical University
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GuangzhouChinaUnknown status
Guangdong Provincial Peoples Hospital
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GuangzhouChinaUnknown status
Affiliated Hospital of Guilin Medical University
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GuilinChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
The Second Hospital of Anhui Medical University
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HefeiChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
Shandong Cancer Hospital
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JinanChinaUnknown status
Yunnan Cancer Hospital
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KunmingChinaUnknown status
The First Hospital of Lanzhou University
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LanzhouChinaUnknown status
Nanjing Chest Hospital
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NanjingChinaUnknown status
General Hospital of Eastern Theater Command
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NanjingChinaUnknown status
The Tumor Hospital Affiliated to Guangxi Medical University
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NanningChinaUnknown status
The Peoples Hospital of Guangxi Zhuang Autonomous Region
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NanningChinaUnknown status
The Affiliated Hospital of Qingdao University Branch South
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QingdaoChinaUnknown status
Shanghai Pulmonary Hospital
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ShanghaiChinaUnknown status
Shanghai Chest Hospital
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ShanghaiChinaUnknown status
Liaoning Cancer Hospital and Institute
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ShenyangChinaUnknown status
The First Hospital of China Medical University
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ShenyangChinaUnknown status
The First Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
Affiliated Cancer Hospital of Xinjiang Medical University
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ÜrümqiChinaUnknown status
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
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WuhanChinaUnknown status
Wuhan Central Hospital
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WuhanChinaUnknown status
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
The First Affiliated hospital of Xiamen University
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XiamenChinaUnknown status
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaUnknown status
Shaanxi Provincial Cancer Hospital
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Xi'anChinaUnknown status
Yantai Yuhuangding Hospital
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YantaiChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.