NCT05775289

A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer

A Phase II, Randomized, Multicenter, Double-Blind, Controlled Study of Tobemstomig Plus Platinum-Based Chemotherapy Versus Pembrolizumab Plus Platinum-Based Chemotherapy in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tobemstomig	Participants will receive intravenous (IV) tobemstomig for four 21-day cycles
DRUG	Pembrolizumab	Participants will receive IV pembrolizumab four 21-day cycles
DRUG	Paclitaxel	Participants will receive IV paclitaxel Q3W for four 21-day cycles
DRUG	Pemetrexed	Participants will receive IV pemetrexed Q3W until disease progression or unacceptable toxicity
DRUG	Carboplatin	Participants will receive IV carboplatin Q3W for four 21-day cycles

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-06-20
• Completion: 2026-06-01
• First posted: 2023-03-20
• Last updated: 2026-02-11
• Results posted: 2025-11-19

Locations

50 sites across 11 countries: United States, Australia, Belgium, Brazil, France, Germany, Italy, Mexico, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study