Trials / Completed
CompletedNCT04294810
A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer
A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 620 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atezolizumab | Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle. |
| DRUG | Tiragolumab | Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle. |
| DRUG | Matching Placebo | Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle. |
Timeline
- Start date
- 2020-03-04
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
- First posted
- 2020-03-04
- Last updated
- 2026-01-30
Locations
134 sites across 23 countries: United States, Australia, Austria, Brazil, China, Germany, Greece, Hungary, Italy, Japan, Mexico, Netherlands, Peru, Poland, Russia, Serbia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04294810. Inclusion in this directory is not an endorsement.