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

ID#: NCT04256421

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: February 04, 2020

End Date: August 31, 2023

Contact Information:
Reference Study ID Number
888-662-6728 (U.S. Only)
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).
Eligibility:

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-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