GFH925 combined with Cetuximab for advanced lung cancer with KRAS G12C mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase Ib/II study evaluates the safety, tolerability, and efficacy of GFH925 in combination with Cetuximab for patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation. The study aims to characterize the pharmacokinetics of GFH925 when used alongside Cetuximab. Participants will be monitored for treatment response and side effects throughout the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• University General Hospital "Attikon"
  Athens, Haidari, Greece Recruiting
• Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
  Bologna, Emilia-Romagna, Italy Recruiting
• IRCCS Centro di Riferimento Oncologico
  Aviano, Friuli-Venezia Giulia, Italy Recruiting
• IOV - Istituto Oncologico Veneto IRCCS
  Padova, Friuli-Venezia Giulia, Italy Recruiting
• Istituto Nazionale Tumori Regina Elena IRCCS
  Roma, Lazio, Italy Recruiting
• Fondazione IRCCS Istituto Nazionale dei Tumori
  Milano, Lombardia, Italy Recruiting

Study contacts

• Study coordinator: Therapeutics Genfleet
• Email: GFH925X0201@genfleet.com
• Phone: +86 21 6882 1388

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.