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NOT YET RECRUITING
NCT07846358
PHASE1/PHASE2

This is a Multicenter, Open-label, Phase I/II Study to Explore the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of GFH276 in Patients With Advanced NSCLC Harboring a RAS Mutation.

Sponsor: Genfleet Therapeutics (Shanghai) Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter Phase Ib/II clinical study evaluating GFH276 in combination with tislelizumab plus pemetrexed/platinum based regimen as first-line therapy in participants with locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) harboring RAS mutation or KRAS amplification.

Official title: A Phase Ib/II, Multicenter, Open-Label Study To Evaluate Safety, Efficacy And Pharmacokinetics Of GFH276 In Combination With Tislelizumab, Pemetrexed And Platinum (Carboplatin Or Cisplatin) As First-Line Therapy In Participants With Locally Advanced Or Metastatic Non-Squamous Non-Small-Cell Lung Cancer Harboring RAS Mutation

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2026-11

Completion Date

2028-12

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DRUG

GFH276

Oral GFH276, administered at specified dose on schedule.

DRUG

with or without Tislelizumab

Tislelizumab 200 mg, intravenous infusion, once every 3 weeks.or without Tislelizumab

DRUG

Pemetrexed

Pemetrexed 500 mg/m², intravenous infusion, once every 3 weeks.

DRUG

Cisplatin

Cisplatin 75 mg/m², intravenous infusion, once every 3 weeks.

DRUG

Carboplatin

Carboplatin at AUC=5, intravenous infusion, once every 3 weeks.