A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer
Summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (RO7247669) in combination with platinum-based chemotherapy compared with pembrolizumab plus platinum-based chemotherapy in participants with previously untreated, locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) non-small-cell lung cancer (NSCLC) who are not eligible to receive curative surgery and/or definitive chemoradiotherapy.
Timeline
- Start
- 2023-03-15
- Primary completion
- 2024-06-20
- Completion
- 2026-04-30
Outcome
Missed primary endpoint
registry analysis (superiority test); Pembro + Chemotherapy vs Tobe + Chemotherapy; p = 0.9705; Hazard Ratio (HR) 0.99 (95% CI 0.63 to 1.56); Log Rank NCT05775289 ↗
registry analysis (superiority test); Pembro + Chemotherapy vs Tobe + Chemotherapy; p = 0.4056; Odds Ratio (OR) 0.77 (95% CI 0.42 to 1.43); Cochran-Mantel-Haenszel NCT05775289 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Subject | Tobemstomig | Monoclonal antibody | — | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |
| Background | Pemetrexed | Small molecule | — | Intravenous |