Clinical trial · Interventional
A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
NCT05756153CI-TRIAL-00093530completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase Ib/II study. The objectives are to evaluate the safety/tolerability and efficacy of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC, to characterize pharmacokinetics (PK) of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advance Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| GFH925 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GFH925+Cetuximab
- interventionNames
- Drug: GFH925
- Drug: Cetuximab
Primary outcomes (2)
- measure
- Phase Ib: adverse events
- timeFrame
- 28 days
- description
- defined as number of patients with treatment emergent AEs
- measure
- Phase II: objective response rate
- timeFrame
- up to 1 year after last patient in
- description
- defined as the percent of patients documented a PR/CR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient has provided informed consent form (ICF). 2. Males or females aged ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1. 4. Life expectancy \> 3 months judged by the investigator. 5. Have histologically or cytologically confirmed advanced KRAS G12C-mutated NSCLC. 6. Have at least one measurable lesion per RECIST 1.1. 7. Have sufficient organ functions. 8. With toxicities left from prior anti-tumor therapy resolved to baseline or CTCAE Grade 1 (neurotoxicity or alopecia ≤ Grade 2). 9. Women of childbearing potential (WOCBP) and male patients with WOCBP partners must agree to use effective contraception method during the study specified period. Exclusion Criteria: 1. With clinically significant cardiovascular diseases. 2. With active central nervous system (CNS) metastases and/or carcinomatous meningitis. 3. With clinically significant gastrointestinal diseases. 4. With active infections. 5. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion. 6. With uncontrolled systemic diseases, such as hypertension or diabetes. 7. Prior treatment with an inhibitor specific to KRAS G12C. 8. Major surgery within 4 weeks prior to initiation of study treatment. 9. With known allergies to the study drugs or components. 10. Pregnant or lactating females, or female patients intend to become pregnant during participation.
References
Publications (1)
- DERIVEDGregorc V, Majem M, Lo Russo G, Maio M, Salvagni S, Gutierrez-Calderon V, Gonzalez-Cao M, Sandiego Contreras S, Koumarianou A, Bearz A, Bernabe-Caro R, Viteri S, de Sanmamed MF, Zagouri F, Moran Bueno T, Lazzari C, Martinez-Recio S, Gimenez-Capitan A, Zhang Y, Shan Y, Zhu H, Zhao C, Shen H, Wang Y, Rosell R. Fulzerasib plus cetuximab in first-line KRASG12C-mutated non-small-cell lung cancer (KROCUS): a single-arm, multicentre, phase 1b/2 trial. Lancet Oncol. 2026 Apr;27(4):432-441. doi: 10.1016/S1470-2045(25)00764-8. PMID 41926959