A Study of GFH925 in Combination with Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

Launched by GENFLEET THERAPEUTICS (SHANGHAI) INC. · Feb 23, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called GFH925 combined with an existing drug called Cetuximab for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change known as the KRAS G12C mutation. The main goals are to see how safe this new combination is and how well it works in fighting the cancer. This study is currently recruiting participants who are at least 18 years old and have been diagnosed with this type of lung cancer. To be eligible, participants should have a good overall health status, meaning they can carry out daily activities without major issues, and their cancer must be measurable through medical imaging.

If you decide to participate, you’ll be closely monitored throughout the study to ensure your safety and to assess how your body responds to the treatment. Participants must also agree to use effective birth control if they are of childbearing age to avoid pregnancy during the study. It’s important to note that individuals with certain health conditions, recent surgeries, or previous specific cancer treatments may not qualify. This trial aims to provide more options for patients with advanced lung cancer, and your involvement could contribute to important findings in cancer treatment.

Gender

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Eligibility criteria

• 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.