A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation

The purpose of this study is to compare the effectiveness, safety and tolerability of GFH375 versus docetaxel in participants with KRAS G12D-mutant non-small cell lung cancer (NSCLC). GFH375 is an oral, highly selective, non-covalent small-molecule inhibitor targeting the KRAS G12D mutation. Preclinical studies showed GFH375 strongly blocks KRAS-driven signaling and cancer cell growth, and demonstrated anti-tumor activity in NSCLC animal models. Docetaxel is a chemotherapy drug for locally advanced or metastatic NSCLC. This is an open-label, randomized controlled trial. Both participant and

Trial Details

NCT ID

NCT07668752

Phase

PHASE3

Sponsor

Genfleet Therapeutics (Shanghai) Inc.

Status

RECRUITING

Cancer Type

Lung Cancer

Interventions

GFH375
Docetaxel

Locations (sample)

Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

1\. Voluntary participation in the study and signed informed consent form (ICF).
2\. Age ≥ 18 years at the time of signing the ICF; male or female.
3\. Histologically or cytologically confirmed locally advanced unresectable or metastatic non small cell lung cancer (NSCLC).
4\. Participants must provide adequate and qualified tumor tissue slides samples or agree to undergo tumor biopsy to obtain tissue samples for cent…

For full eligibility, visit ClinicalTrials.gov.

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