NCT04308785

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

A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 2 Study to Investigate the Efficacy and Safety of Atezolizumab With or Without Tiragolumab as Consolidation Therapy in Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Participants can receive concurrent or sequential chemoradiotherapy (CRT) as per local standard of care, but they must be randomized within 6 weeks from completion of chemoradiotherapy. Participants should receive 4 cycles of chemotherapy and radiotherapy dose of 56-64 Gy (once daily) before randomization, and those participants who have not progressed during/after CRT will be stratified by response to CRT, radiotherapy timing, and be randomized in a 1:1 ratio to Atezolizumab+Tiragolumab arm or Atezolizumab+placebo arm.

Conditions

• Carcinoma, Small Cell Lung

Interventions

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

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-07-25
• Completion: 2023-07-25
• First posted: 2020-03-16
• Last updated: 2023-10-23

Locations

17 sites across 1 country: China