NCT07846358Not yet recruitingPhase 1/2
This is a Multicenter, Open-label, Phase I/II Study to Explore the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of GFH276 in Patients With Advanced NSCLC Harboring a RAS Mutation.
A Phase Ib/II, Multicenter, Open-Label Study To Evaluate Safety, Efficacy And Pharmacokinetics Of GFH276 In Combination With Tislelizumab, Pemetrexed And Platinum (Carboplatin Or Cisplatin) As First-Line Therapy In Participants With Locally Advanced Or Metastatic Non-Squamous Non-Small-Cell Lung Cancer Harboring RAS Mutation
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
This is an open-label, multicenter Phase Ib/II clinical study evaluating GFH276 in combination with tislelizumab plus pemetrexed/platinum based regimen as first-line therapy in participants with locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) harboring RAS mutation or KRAS amplification.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 22 Sept 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Diseases
- Lung cancer
- NCT number
- NCT07846358
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 84
- From Nov 2026 to the primary completion date, Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior anti-tumor therapy within 28 days or 5 half-lives
- Diagnosis of unstable thrombotic events requiring therapeutic intervention within 3 months prior to the first dose of study treatment.
Other illness
- Other active malignancy within 3 years
- Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor
- History of active clinically significant cardiovascular dysfunction
- Presence of active infection (HIV, HBV, HCV,)
- Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures.
- History of central nervous system (CNS)disease
- Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment.
- Active autoimmune disease requiring systemic treatment.
Other
- Known to harbor other targetable driver gene alterations
- With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.
Who the study is looking for
- Histologically/cytologically confirmed locally advanced or metastatic non squamous NSCLC (AJCC 8th edition Stage IIIB-IV).
- Confirmed RAS mutation or KRAS amplification；tumor cell PD L1 test report available
- No prior systemic anti-tumor therapy for advanced disease
- At least 1 measurable lesion outside the central nervous system (CNS) per RECIST v1.1
- ECOG performance status 0 or 1
- Life expectancy\>3 months
- Willing to provide written informed consent
- Fertile participants must use effective contraception
- Adequate organ function
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.