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NCT04665856CompletedPhase 3

Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

The purpose of this multicenter study in China is to evaluate the safety and efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with untreated extensive-stage small cell lung cancer.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
123 (actual)
First submitted
7 Dec 2020
Start date
21 Dec 2020
Primary completion date
31 Aug 2023
Lead sponsor
Hoffmann-La Roche
Diseases
Lung cancer
NCT number
NCT04665856

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 123
  • From 21 Dec 2020 to the primary completion date, 31 Aug 2023
  • 16 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

  • Malignancies other than SCLC within 5 years prior to randomization
  • Known active tuberculosis, Current treatment with anti-viral therapy for HBV or HCV
  • Treatment with therapeutic oral or IV antibiotics
  • Major surgical procedure other than for diagnosis
  • Prior allogeneic bone marrow transplantation or solid organ transplant
  • Administration of a live, attenuated vaccine
  • Prior treatment with CD137 agonists, T-cell co-stimulating, or immune checkpoint blockade therapies
  • Treatment with systemic immunostimulatory agents
  • Treatment with systemic immunosuppressive medications

Other illness

  • Leptomeningeal disease
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse
  • Active or history of autoimmune disease or immune deficiencies
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computer Tomography (CT) scan
  • Severe chronic or active infection
  • Significant cardiovascular disease
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to Chinese Hamster Ovary (CHO) cell products or to any component of the tiragolumab or atezolizumab formulations
  • History of allergic reactions to carboplatin or etoposide

Lab values

  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition

Other

  • Symptomatic or actively progressing central nervous system (CNS) metastases
  • Spinal cord compression
  • Uncontrolled pleural effusion, pericardial effusion, or ascites
  • Uncontrolled or symptomatic hypercalcemia
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or within 90 days after the final dose of tiragolumab or for 6 months after the final dose of carboplatin or etoposide.

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the modified Veterans Administration Lung Study Group (VALG) staging system
  • No prior systemic treatment for ES-SCLC
  • For participants who have received prior chemoradiotherapy for limited-stage SCLC must have had treatment with curative intent and a treatment-free interval of at least 6 months between the last dose/cycle of chemotherapy, thoracic radiotherapy, or chemoradiotherapy and the diagnosis of ES-SCLC
  • Measurable diseases as defined by RECIST v1.1
  • Submission of a pre-treatment tumor tissue sample
  • Adequate hematologic and end-organ function
  • Participants not receiving therapeutic anticoagulation with International Normalized Ratio (INR) and Activated Clotting Time (aPTT) \</= 1.5 x ULN
  • Participants receiving therapeutic anticoagulation: stable anticoagulant regimen
  • Negative Human Immunodeficiency Virus (HIV) test at screening
  • Negative hepatitis B surface antigen (HBsAg) test at screening
  • Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) and/or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test
  • Negative Epstein-Barr virus (EBV) viral capsid antigen (VCA) IgM test or negative EBV polymerase chain reaction (PCR) test at screening
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

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

SiteCityCountrySite status
Beijing Cancer Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Beijing Chest Hospital
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BeijingChinaUnknown status
The First Affiliated Hospital of Bengbu Medical College
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BengbuChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Fujian Provincial Cancer Hospital
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FuzhouChinaUnknown status
Cancer Center of Guangzhou Medical University
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GuangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
The 1st Affiliated Hospital of Nanchang Unversity
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NanchangChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Shanghai Chest Hospital
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ShanghaiChinaUnknown status
Zhongshan Hospital,Fudan University
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ShanghaiChinaUnknown status
Cancer Hospital of Shantou University Medical College
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ShantouChinaUnknown status
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status

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