# GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer

Source: https://onco.cc/trials/nct07554859/  
OnCo record `nct07554859` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial in lung cancer, run by Genfleet Therapeutics (Shanghai) Inc., not yet recruiting.

## Summary

GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer is a phase 2, randomised interventional study registered as NCT07554859 by Genfleet Therapeutics (Shanghai) Inc., with a registry enrolment figure of 90 participants, started 2026-05-20 and due to reach its primary completion in 2027-04-30. Interventions recorded: ArmA:GFH375; Arm B:GFH375; Arm C:GFH375. Conditions listed: NSCLC (Advanced Non-small Cell Lung Cancer). Primary outcome: the efficacy of GFH375 as monotherapy and in combination therapy. Lung eligibility wording from the registry: "Pathologically (histologically or cytologically) confirmed advanced (Stage IV) or locally advanced non-squamous non-small cell lung cancer that is not amenable to radical surgery or radiotherapy". Sites: China. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-25
- Tags: ctgov-ingest; lung-deep-dive
- Registry id: NCT07554859
- Phase: 2
- Setting: 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.
- Sponsor: Genfleet Therapeutics (Shanghai) Inc.
- Enrolled: 90

## Sources

- ClinicalTrials.gov NCT07554859: https://clinicaltrials.gov/study/NCT07554859

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- companies: [GenFleet Therapeutics](https://onco.cc/companies/genfleet/)
- terms: [Lung cancer trials open today (registry snapshot)](https://onco.cc/terms/lung-trials-open-today/)

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