Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tiragolumab + Atezolizumab + CE
Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by tiragolumab on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.
  • Drug: Tiragolumab
    Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.
    Other names:
    • MTIG7192A
  • Drug: Atezolizumab
    Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
    Other names:
    • Tecentriq
  • Drug: Carboplatin
    Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
  • Drug: Etoposide
    Etoposide 100 mg/m^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
Active Comparator
Placebo + Atezolizumab + CE
Participants will receive atezolizumab on Day 1 of each 21-day cycle followed by placebo on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.
  • Drug: Atezolizumab
    Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
    Other names:
    • Tecentriq
  • Drug: Carboplatin
    Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
  • Drug: Etoposide
    Etoposide 100 mg/m^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
  • Drug: Placebo
    Placebo administered by IV infusion on Day 1 of each 21-day cycle.

Recruiting Locations

Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GO41767 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.