NCT03563716

A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase II, Randomized, Blinded, Placebo-Controlled Study of Tiragolumab, An Anti-TIGIT Antibody, In Combination With Atezolizumab In Chemotherapy-Naïve Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.
DRUG	Tiragolumab	Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
DRUG	Placebo	Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Timeline

• Start date: 2018-08-10
• Primary completion: 2019-06-30
• Completion: 2025-11-24
• First posted: 2018-06-20
• Last updated: 2026-01-20
• Results posted: 2020-07-09

Locations

40 sites across 6 countries: United States, France, Serbia, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study