A Study of Atezolizumab With or Without Tiragolumab Consolidation in Limited Stage Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT04308785
Phase
PHASE2
Status
Terminated

Conditions

  • Carcinoma, Small Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered at a dose of 1200 mg intravenously on the first day of each 21-day cycle.
  • Tiragolumab — DRUG
    Tiragolumab will be administered at a dose of 600 mg intravenously on the first day of each 21-day cycle.
  • Placebo — OTHER
    Placebo matching to tiragolumab will be administered at a dose of 600 mg intravenously on the first day of each cycle.

Study Details

This is a multicenter, double-blind, placebo-controlled, randomized, phase II study to investigate the efficacy and safety of Atezolizumab with or without Tiragolumab as consolidation therapy in participants with limited stage small cell lung cancer who have not progressed during/after chemoradiotherapy.

Key Dates

Start date
Dec 1, 2021
Status verified
Oct 2023
Primary completion
Jul 25, 2023
Completion
Jul 25, 2023

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Atezolizumab + Tiragolumab
    Participants will receive atezolizumab + tiragolumab intravenously on the first day of each cycle. One cycle of therapy will be defined as 21 days. Atezolizumab and tiragolumab treatment will continue up to 17 doses unless investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).
  • Experimental: Arm B: Atezolizumab + Placebo
    Participants will receive atezolizumab + placebo on the first day of each cycle. One cycle of therapy will be defined as 21 days. Atezolizumab and placebo treatment will continue up to 17 doses unless investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).

Primary Outcome Measure

Investigator Assessed Progression-Free Survival (PFS) in the Intent-To-Treat (ITT) Population [ Time Frame: Randomization up to approximately 48 months ]

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