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GFH276 + Tislelizumab + Chemotherapy in First-Line Advanced Non-Squamous NSCLC with RAS Mutation
NCT07846358Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2026
- Primary completion
- Dec 2027
- Sponsor
- GenFleet Therapeutics
- Drugs
- GFH276
- Conditions
- non-small cell lung cancer (NSCLC)
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Overview
Phase 2, open-label, single-arm trial of GFH276 in non-small cell lung cancer (NSCLC), sponsored by GenFleet Therapeutics. Primary endpoints: Dose-Limiting Toxicity at 21 days, Objective Response Rate at 36 months and 1 more. Planned start Nov 2026; status: not yet recruiting.
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Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
GFH276 ±Tislelizumab + AP
GFH276 once daily; Tislelizumab 200 mg, IV; AP: Pemetrexed 500 mg/m², IV; Cisplatin/Carboplatin 75 mg/m²/AUC=5, IV, every 3 weeks
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Who it enrols
Patients with locally advanced or metastatic non-squamous NSCLC harboring RAS mutation or KRAS amplification, with no prior systemic therapy for advanced disease, ECOG 0-1, and adequate organ function.
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Endpoints
Primary
Dose-Limiting Toxicity
Objective Response Rate
Adverse Events and Serious Adverse Events
Secondary
Disease Control Rate
Duration of Response
Time to Response
Progression-Free Survival
Overall Survival
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