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

Completed · Phase 3 · Has a placebo group

Conditions studied: Small Cell Lung Cancer

In brief

This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (\</= upper limit of normal \[ULN\] vs. \> ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase: * Arm A: Tiragolumab plus atezolizumab plus CE * Arm B: Placebo plus atezolizumab plus CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).

Key facts

Study ID

NCT04256421

Run by

Hoffmann-La Roche

People needed

490

Starts

2020-02-04

Expected to finish

2025-07-31

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
• No prior systemic treatment for ES-SCLC
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
• Adequate hematologic and end-organ function
• Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC

You may not qualify if…

• Symptomatic or actively progressing central nervous system (CNS) metastases
• Malignancies other than small cell lung cancer (SCLC) within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• Positive test result for human immunodeficiency virus (HIV)
• Active hepatitis B or hepatitis C
• Severe infection at the time of randomization
• Treatment with any other investigational agent within 28 days prior to initiation of study treatment
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-cytotoxic T lymphocyte-associated protein 4 (anti-CTLA-4), anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
• Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to randomization

Where it is running

• MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• SCRI Florida Cancer Specialists North — Sarasota, Florida, United States
• Northwest Georgia Oncology Centers PC - Marietta — Marietta, Georgia, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• New England Cancer Specialists — Scarborough, Maine, United States
• Weinberg Cancer Institution at Franklin Square — Baltimore, Maryland, United States
• Minnesota Oncology Hematology — Minneapolis, Minnesota, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• Broome Oncology - Binghamton — Binghamton, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Sarah Cannon Research Institute / Tennessee Oncology — Chattanooga, Tennessee, United States
• Sarah Cannon Research Inst. — Nashville, Tennessee, United States
• Texas Oncology Cancer Center — Austin, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Blue Ridge Cancer Care — Roanoke, Virginia, United States
• University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
• Nepean Hospital — Kingswood, New South Wales, Australia
• Sunshine Coast University Hospital — Birtinya, Queensland, Australia
• Lyell McEwin Hospital — Elizabeth Vale, South Australia, Australia
• Tiroler Landeskrankenanstalten Ges.M.B.H. — Innsbruck, Austria
• Klinik Penzing — Vienna, Austria
• Krankenhaus Nord - Klinik Floridsdorf — Vienna, Austria
• Rocky Mountain Cancer Centers - Lone Tree — Lone Tree, Colorado, United States

Full record on ClinicalTrials.gov

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