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

ConditionNSCLC (Advanced Non-small Cell Lung Cancer)

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorGenfleet Therapeutics (Shanghai) Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily agree to participate in this study and sign the written informed consent form.

Male or female, aged 18 to 75 years at the time of signing the informed consent form.

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.

Have a written report confirming KRAS G12D mutation positive.

Disqualifiers

Has had another invasive malignancy that progressed or required treatment within 3 years prior to randomization, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, squamous cell carcinoma in situ, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or papillary thyroid carcinoma.

Pathologically (histologically or cytologically) confirmed squamous cell lung cancer, adenosquamous carcinoma, neuroendocrine carcinoma (including small cell lung cancer and large cell neuroendocrine carcinoma), or mixed small cell lung cancer.

Known to harbor other targetable driver gene alterations.

Has active or symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression.

Trial design

Design model

Parallel

Treatments tested in this trial

ArmA:GFH375
Drug
GFH375 once daily (QD) 28 days as a cycle.
Arm B:GFH375
Drug
GFH375 once daily (QD) .Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.
Arm C:GFH375
Drug
GFH375 once daily (QD) .Pemetrexed disodium will be administered via intravenous infusion at a dose of 500 mg/m² every 3 weeks.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Arm A:GFH375Experimental treatment 1 intervention

Group B: Arm B:GFH375 in combination with CetuximabExperimental treatment 1 intervention

Group C: Arm C:GFH375 in combination with PemetrexedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

the efficacy of GFH375 as monotherapy and in combination therapy

Objective response rate (ORR) assessed by RECIST 1.1 according to researchers

Time frame

From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genfleet Therapeutics (Shanghai) Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: