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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05756153

Enrollment

Registered

2023-03-06

Start date

2023-04-25

Completion date

2025-04-30

Last updated

2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advance Non-small Cell Lung Cancer

Brief summary

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

Interventions

DRUGGFH925

GFH925 tablets administered orally daily.

DRUGCetuximab

Cetuximab administered intravenously Q2W.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Phase Ib: adverse events	28 days	defined as number of patients with treatment emergent AEs
Phase II: objective response rate	up to 1 year after last patient in	defined as the percent of patients documented a PR/CR

Countries

Greece, Italy, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026