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

Trial number:
NCT04256421
Trial phase:
3
Study type:
Immunotherapy, Chemotherapy
Overall status:
Recruiting

Study start date

February, 2020

Scientific 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

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 randomized in a 1:1 ratio to receive one of the following treatment regimens during induction phase:- - Arm A: Tiragolumab plus atezolizumab and CE - Arm B: Placebo plus atezolizumab and CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).

- 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

- 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-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

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: Triple, Subject masked: Yes, Caregiver masked: Yes, Investigator masked: Yes,

Conditions

Small Cell Lung Cancer

Other study ID numbers

GO41767; 2019-003301-97

Choose trial site (150)

National University Hospital 119074
National University Hospital 119074 Recruiting
Singapore 119074
National Cancer Centre Singapore
National Cancer Centre Singapore Completed
11 Hospital Crescent, Singapore 169610