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A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer (SKYSCRAPER-06)
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase: * Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin * Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | PHASE2, PHASE3 |
| Status | COMPLETED |
| Enrolment | 542 |
| Start date | Tue Dec 15 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Nov 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Non-small Cell Lung Cancer (NSCLC)
Interventions
- Tiragolumab
- Atezolizumab
- Pemetrexed
- Carboplatin
- Cisplatin
- Tiragolumab Matching Placebo
- Pembrolizumab
Countries
Hong Kong, Italy, Japan, Taiwan, Poland, South Korea, Denmark, New Zealand, Belgium, Mexico, Thailand, United States, France, Canada, Spain, Brazil, United Kingdom, Germany, Switzerland, China, Turkey (Türkiye)