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Study on the Safety and Effectiveness of GFH925 and Cetuximab for Patients with Advanced Lung Cancer with KRAS G12C Mutation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called the KRAS G12C mutation. The study is testing a new treatment combination for this cancer, which includes a medication called GFH925 and another medication known as cetuximab. GFH925 is a chemical drug, while cetuximab is a protein-based drug that is given through an intravenous infusion, meaning it is delivered directly into the bloodstream.

The purpose of the study is to evaluate how safe and effective this combination of GFH925 and cetuximab is for patients who have not received any previous treatment for their advanced NSCLC. The study is divided into two phases. In the first phase, the focus is on understanding the safety and tolerability of the treatment, which means checking how well patients can handle the medications and if there are any side effects. The second phase aims to assess how well the treatment works in controlling the cancer.

Participants in the study will receive the treatment and be monitored for any changes in their health, including side effects and how their cancer responds to the treatment. The study will also involve regular check-ups, blood tests, and other assessments to gather information on the treatment's impact. The trial is expected to continue until March 2025, providing valuable insights into the potential benefits of this new treatment combination for patients with advanced NSCLC harboring the KRAS G12C mutation.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide a signed informed consent form. This document confirms your understanding of the study and your willingness to participate.

    If you are a woman of childbearing potential, a pregnancy test will be conducted within one week before starting the study treatment to ensure negative results.

  2. Step 2

    Initial assessments

    You will undergo initial assessments to confirm eligibility, including a review of your medical history and a physical examination.

    Blood tests and imaging studies may be conducted to evaluate your overall health and the status of your condition.

  3. Step 3

    Treatment phase

    The treatment involves two medications: cetuximab and GFH925. Cetuximab is administered as an intravenous infusion, which means it is given directly into your vein. GFH925 is taken orally in the form of tablets.

    The dosage and frequency of these medications will be determined by the study team based on your specific needs and the study protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring will be conducted to assess your response to the treatment and to check for any side effects. This includes blood tests, physical exams, and possibly imaging studies.

    You will be required to attend scheduled visits to the study center for these assessments.

  5. Step 5

    End of treatment

    At the end of the treatment phase, a final assessment will be conducted to evaluate the overall response to the treatment.

    You may be asked to provide feedback on your experience during the study.

Who can join the trial?

17 criteria

  • The patient must have given their agreement to participate by signing a consent form. If the patient cannot give consent, a legal representative can do so on their behalf.
  • Women of childbearing potential (women who can become pregnant) and male patients with partners who can become pregnant must agree to use effective birth control during the study and for a certain period after the study ends. Women must have a negative pregnancy test before starting the study.
  • The patient must be at least 18 years old.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
  • The patient must have a life expectancy of more than 3 months, as judged by the study doctor.
  • The patient must be willing to provide a sample of their tumor tissue and blood for analysis.
  • The patient must have advanced NSCLC (a type of lung cancer) that has not been treated with systemic therapy for advanced or metastatic disease. They must meet the following conditions:
    • They are not willing to receive immunochemotherapy or may benefit more from the study treatment as judged by the study doctor.
    • They have a documented KRAS G12C mutation (a specific genetic change in the cancer).
    • They do not have other targetable genetic changes like EGFR mutations or ALK/ROS1 rearrangements.
    • If they had previous chemotherapy or chemoradiotherapy for non-metastatic disease, they must have had a break of at least 6 months before starting the study treatment.
    • The patient must have at least one measurable tumor, except if they only have cancer spread to the brain.
    • The patient must have adequate organ function, including:
      • Enough blood cells: white blood cells, platelets, and hemoglobin must be at certain levels without recent blood transfusions or medications to boost blood cell production.
      • Liver function: certain liver enzymes and bilirubin must be below specific levels.
      • Kidney function: creatinine levels must be below a certain level, or creatinine clearance must be above a certain level.
      • Blood clotting: certain blood clotting tests must be within normal limits.
      • Magnesium levels must be normal.
      • Any side effects from previous cancer treatments must have improved to a mild level or returned to the patient's normal state, except for mild nerve damage or hair loss.

Who cannot join the trial?

10 criteria

  • Patients who have already received treatment for their advanced NSCLC (a type of lung cancer) with the KRAS G12C mutation cannot participate.
  • Patients with other types of cancer that are not stable or are being actively treated are excluded.
  • Patients with serious heart problems, such as uncontrolled high blood pressure or recent heart attacks, are not eligible.
  • Patients with severe liver or kidney disease cannot take part in the study.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients with known allergies to the study drugs or similar drugs are excluded.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
  • Patients with active infections, such as HIV or hepatitis, are not allowed to participate.
  • Patients who have received another investigational drug within a certain period before the study starts are excluded.
  • Patients with a history of drug or alcohol abuse that could interfere with the study are not eligible.
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Investigated drugs

  • GFH925

    is a new medication being tested in this clinical trial. It is designed to target a specific mutation in cancer cells known as KRAS G12C, which is found in some patients with advanced non-small cell lung cancer (NSCLC). The goal of using GFH925 is to see if it can help stop or slow down the growth of cancer cells that have this mutation.

  • Cetuximab

    is a medication that is already used to treat certain types of cancer. It works by blocking a protein on the surface of cancer cells, which can help stop the cells from growing and dividing. In this trial, Cetuximab is being used in combination with GFH925 to see if the two medications together can be more effective in treating advanced NSCLC with the KRAS G12C mutation than using either medication alone.

What is already known about the treatment

GFH925 – GFH925 is administered in combination with Cetuximab for the treatment of advanced non-small cell lung cancer (NSCLC) that has not been previously treated and carries a specific genetic mutation known as KRAS G12C. This medication is currently being studied in clinical trials to assess its safety, tolerability, and effectiveness. GFH925 works by targeting and inhibiting the KRAS G12C mutation at the molecular level, which is a key driver of cancer cell growth in this type of lung cancer. It is classified as a targeted cancer therapy, aiming to specifically disrupt cancer cell processes while minimizing effects on normal cells.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation – Non-Small Cell Lung Cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The KRAS G12C mutation is a specific genetic alteration found in some NSCLC cases, affecting the KRAS gene, which plays a role in cell signaling pathways that control cell growth and division. This mutation leads to continuous activation of the KRAS protein, promoting cancer cell growth and survival. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, bones, brain, and liver. Symptoms may include persistent cough, chest pain, shortness of breath, and unexplained weight loss. The progression of NSCLC with KRAS G12C mutation can vary, and it often requires monitoring for changes in tumor size and spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-501451-87-00Protocol codeGFH925X0201Estimated enrolment32 patientsSponsorZhejiang Genfleet Therapeutics Co. Ltd.

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