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A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
- Cancer
- Lung Cancer
- Small Cell Lung Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Active, not recruiting
This trial runs in
Cities
- Adana
- Ankara
- Athens
- Auckland
- Austin
- Bahia
- Baltimore
- Barcelona
- Bari
- Beograd
- Berlin
- Binghamton
- Birtinya
- Brzozów
- Budapest
- Camperdown
- cascina-perseghetto
- Catania
- Ceará
- Chattanooga
- cheongju
- Chuo City
- Denver
- Edinburgh
- Elizabeth Vale
- Faenza
- Fairfax
- Fukuoka
- Gauting
- Gdańsk
- Goyang-si
- Großhansdorf
- Hamburg
- Hlavní město Praha
- Immenhausen
- Ina
- Innsbruck
- İstanbul
- İzmir
- Kashiwa
- Kingswood
- Koto City
- Kraków
- Las Vegas
- Lausanne
- London
- Lone Tree
- Lübeck
- Maastricht
- Madison
- Madrid
- Manchester
- Marietta
- Marousi
- Mechelen
- Moscow Oblast
- Moskva
- Málaga
- München
- Nagaizumi
- Namur
- Napoli
- Nashville
- New York
- Niigata
- Olomouc
- Olsztyn
- Osaka
- Osakasayama
- Ostrava
- Otwock
- Padova
- Peoria
- Poznań
- Rio Grande do Sul
- Roanoke
- Roeselare
- Rotterdam
- Saint Paul
- Saint Petersburg
- Sakai
- Sanatorio San Luigi
- Santa Catarina
- Sarasota
- Scarborough
- Seongnam-si
- Seoul
- Sevilla
- Siena
- Singapore
- Sint-Niklaas
- Sremska Kamenica
- St. Petersburg
- Sutton
- Szolnok
- São Paulo
- Tainan City
- Taipei City
- Taoyuan City
- Truro
- Törökbálint
- Ulsan
- València
- Wakayama
- Warszawa
- Washington
- Wien
- Zaragoza
- Zürich
- 창원시
Trial Identifier:
NCT04256421 2019-003301-97 GO41767
Trial Summary
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).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04256421,GO41767,2019-003301-97
Trial Identifier
Tiragolumab, Atezolizumab, Carboplatin, Etoposide, Placebo
Treatments
Small Cell Lung Cancer
Condition
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab (Anti-Tigit Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- 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
Exclusion Criteria
- 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
For the latest version of this information please go to www.forpatients.roche.com