Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
NCT ID: NCT04665856
Last Updated: 2025-10-29
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
123 participants
INTERVENTIONAL
2020-12-21
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tiragolumab + Atezolizumab + Carboplatin and Etoposide
Induction treatment with tiragolumab plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab plus atezolizumab for 21-day cycles.
Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin administered IV to achieve an initial target area under the concentration time curve (AUC) of 5 mg/mL/min, Q3W on Day 1 of each 21-day cycle for 4 cycles.
Etoposide
Etoposide 100 mg/m\^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles.
Placebo + Atezolizumab + Carboplatin and Etoposide
Induction treatment with placebo plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo plus atezolizumab for 21-day cycles
Atezolizumab
Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin administered IV to achieve an initial target area under the concentration time curve (AUC) of 5 mg/mL/min, Q3W on Day 1 of each 21-day cycle for 4 cycles.
Etoposide
Etoposide 100 mg/m\^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles.
Tiragolumab Matching Placebo
Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Interventions
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Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin administered IV to achieve an initial target area under the concentration time curve (AUC) of 5 mg/mL/min, Q3W on Day 1 of each 21-day cycle for 4 cycles.
Etoposide
Etoposide 100 mg/m\^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles.
Tiragolumab Matching Placebo
Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Spinal cord compression
* Leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites
* Uncontrolled or symptomatic hypercalcemia
* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse
* Malignancies other than SCLC within 5 years prior to randomization
* 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
* Known active tuberculosis, Current treatment with anti-viral therapy for HBV or HCV
* Severe chronic or active infection
* Treatment with therapeutic oral or IV antibiotics
* Significant cardiovascular disease
* Major surgical procedure other than for diagnosis
* Prior allogeneic bone marrow transplantation or solid organ transplant
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition
* 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
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Beijing Cancer Hospital
Beijing, , China
Beijing Chest Hospital
Beijing, , China
the First Affiliated Hospital of Bengbu Medical College
Bengbu, , China
the First Hospital of Jilin University
Changchun, , China
Fujian Provincial Cancer Hospital
Fuzhou, , China
Cancer Center of Guangzhou Medical University
Guangzhou, , China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, , China
Shanghai Chest Hospital
Shanghai, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Cancer Hospital of Shantou University Medical College
Shantou, , China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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YO42373
Identifier Type: -
Identifier Source: org_study_id
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