CI

At a glance

ClinicalIndex Comparison Record
Phase 2Not Yet Recruiting· 90 target
Drug / intervention
ArmA:GFH375 +2 moredrug
Likely dose
Arm B:GFH375 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07554859
NCT07554859Phase 2Not Yet Recruiting
CompareCT.gov

A Multicenter, Open-label, Randomized Clinical Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of GFH375 Monotherapy and Combination Therapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer Harboring KRAS G12D Mutation.

Genfleet Therapeutics (Shanghai) Inc.·interventional·Posted Apr 28, 2026·Updated Apr 28, 2026

In Brief

A Phase 2 clinical trial evaluating ArmA:GFH375, Arm B:GFH375, and 1 other intervention for NSCLC (Advanced Non-small Cell Lung Cancer). Not yet recruiting, targeting 90 participants across 2 sites.

Detailed Summary

This study is a multicenter, open-label, randomized clinical trial aimed at exploring the efficacy and safety of three treatment regimens for treatment-naive advanced NSCLC patients with KRAS G12D mutation: GFH375 monotherapy (Cohort 1), GFH375 combined with cetuximab (Cohort 2), and GFH375 combined with pemetrexed (Cohort 3).Every cohort will recruit 30 participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNSCLC (Advanced Non-small Cell Lung Cancer)
CountriesChina
Collaborators--

Timeline

Phase 2Not Yet Recruiting
20272028
First PostedApr 28, 2026
Enrollment StartMay 20, 2026
Primary CompletionApr 30, 2027
Study CompletionApr 30, 2028
TodayJul 1, 2026
Enrollment to primary: 11 monthsPosted 2 months agoPrimary completion in 10 months

Interventions

ArmA:GFH375drug

GFH375 once daily (QD) 28 days as a cycle.

Arm B:GFH375drug

GFH375 once daily (QD) .Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.

Arm C:GFH375drug

GFH375 once daily (QD) .Pemetrexed disodium will be administered via intravenous infusion at a dose of 500 mg/m² every 3 weeks.