GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant … (NCT07554859) | Clinical Trial Compass
Not Yet RecruitingPhase 2
GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer
China90 participantsStarted 2026-05-20
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Able to provide an archival tumor tissue sample \[formalin-fixed, paraffin-embedded (FFPE) block or unstained FFPE tumor sections\] or to undergo a tumor biopsy prior to treatment.
✓. No prior systemic anti-tumor therapy for advanced disease; or not eligible for standard of care therapy; or in the investigator's judgment, may benefit more from GFH375 monotherapy or combination therapy than from available standard therapy.
✓. Have at least one measurable lesion outside the central nervous system (CNS) per RECIST v1.1. Lesions that have received prior local radiotherapy can be considered measurable only if they have demonstrated clear progression after radiotherapy; otherwise, they are not considered measurable.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
Exclusion criteria
✕. 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.
What they're measuring
1
the efficacy of GFH375 as monotherapy and in combination therapy
Timeframe: 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
✕. 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.
✕. Has clinically significant severe cardiovascular disease.
✕. Has had a stroke or other serious cerebrovascular event within 6 months prior to randomization.
✕. Has a history of deep vein thrombosis or other severe thromboembolism within 3 months prior to randomization.
✕. Has pleural effusion, ascites, or pericardial effusion requiring frequent drainage (≥2 times per month) or associated with moderate to severe symptoms.