Clinical trial · Interventional
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
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| RAS Mutation | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| GFH276 | Drug | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| with or without Tislelizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GFH276 ±Tislelizumab + AP
- description
- GFH276 once daily; Tislelizumab 200 mg, IV; AP: Pemetrexed 500 mg/m², IV; Cisplatin/Carboplatin 75 mg/m²/AUC=5, IV, every 3 weeks
- interventionNames
- Drug: GFH276
- Drug: with or without Tislelizumab
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
Primary outcomes (3)
- measure
- Phase Ib:Incidence of Dose-Limiting Toxicity (DLT) Events
- timeFrame
- First 21 days
- description
- The incidence of DLT events
- measure
- Phase II:Objective Response Rate (ORR)
- 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 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically/cytologically confirmed locally advanced or metastatic non squamous NSCLC (AJCC 8th edition Stage IIIB-IV). 2. Confirmed RAS mutation or KRAS amplification;tumor cell PD L1 test report available 3. No prior systemic anti-tumor therapy for advanced disease 4. At least 1 measurable lesion outside the central nervous system (CNS) per RECIST v1.1 5. ECOG performance status 0 or 1 6. Life expectancy\>3 months 7. Willing to provide written informed consent 8. Fertile participants must use effective contraception 9. Adequate organ function Exclusion Criteria: 1. Other active malignancy within 3 years 2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor 3. History of active clinically significant cardiovascular dysfunction 4. Known to harbor other targetable driver gene alterations 5. Presence of active infection (HIV, HBV, HCV,) 6. Prior anti-tumor therapy within 28 days or 5 half-lives 7. Diagnosis of unstable thrombotic events requiring therapeutic intervention within 3 months prior to the first dose of study treatment. 8. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures. 9. History of central nervous system (CNS)disease 10. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment. 11. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion. 12. Active autoimmune disease requiring systemic treatment.
References
Publications (0)
Data not yet available