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Study of zoldonrasib with daraxonrasib, pembrolizumab and chemotherapy in patients with RAS G12D-mutant non-small cell lung cancer

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What is this trial about?

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

This study focuses on patients with Non-Small Cell Lung Cancer (NSCLC) that has a specific genetic change called RAS G12D mutation. The study will test new treatments using combinations of different medications including zoldonrasib (RMC-9805) and daraxonrasib (RMC-6236), together with pembrolizumab and standard chemotherapy drugs (cisplatin, carboplatin, and pemetrexed).

The main purpose of this research is to determine if these drug combinations are safe to use and to find the right dose that works best for patients. The medications will be given in different ways - some as tablets taken by mouth, while others will be given through an infusion into a vein.

During the study, doctors will monitor patients' health closely and check how well the treatment is working by looking at changes in their cancer. They will also study how the medications move through the body and how long the beneficial effects of the treatment last. The study will continue for approximately two years.

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

    Initial evaluation

    Your eligibility for the study will be assessed based on specific criteria, including confirmation of RAS G12D mutation in your non-small cell lung cancer (NSCLC)

    Medical tests will be performed to evaluate your organ function and measure existing tumors

  2. Step 2

    Treatment assignment

    You will be assigned to receive one of the following treatment combinations:

    Option 1: RMC-9805 with pembrolizumab

    Option 2: RMC-9805 and daraxonrasib with pembrolizumab

    Option 3: RMC-9805 with pembrolizumab and chemotherapy (cisplatin or carboplatin with pemetrexed)

    Option 4: RMC-9805 and daraxonrasib with pembrolizumab and chemotherapy

  3. Step 3

    Treatment administration

    Some medications will be given as infusions at the clinic

    Some medications will be taken as tablets at home

    Your treatment will continue as long as it is safe and effective

  4. Step 4

    Monitoring

    Regular blood tests will measure medication levels in your body

    Your tumor response will be evaluated through imaging tests

    Side effects and changes in your health will be monitored throughout the study

    Your vital signs and laboratory test results will be regularly checked

  5. Step 5

    Study duration

    The study is expected to run from November 2025 to February 2027

    Your participation duration will depend on how your body responds to the treatment

Who can join the trial?

8 criteria

  • You must be at least 18 years old
  • You must have non-small cell lung cancer (NSCLC) with a specific genetic change called RAS-G12D mutation
  • You must either have received previous cancer treatments or be unable to receive standard treatment options
  • You must have at least one tumor that can be measured by medical imaging tests
  • Your body organs must be working well enough, including:
    • Bone marrow (where blood cells are made)
    • Liver (organ that helps clean toxins from body)
    • Kidneys (organs that filter blood)
    • Normal blood clotting ability

Who cannot join the trial?

11 criteria

  • Previous treatment with any RMC-9805 or RMC-6236 therapy
  • Active brain metastases (cancer that has spread to the brain) or spinal cord compression that is not treated and stable
  • History of other cancers within 3 years before starting the study, except for successfully treated non-melanoma skin cancer or cervical cancer in situ (early-stage cancer)
  • Serious heart conditions, including:
    • Heart attack within the last 6 months
    • Unstable chest pain
    • Severe heart rhythm problems
    • Active autoimmune disease (condition where immune system attacks healthy cells) requiring systemic treatment
    • Active infection requiring treatment, including hepatitis B, hepatitis C, or HIV
    • Pregnant or breastfeeding women
    • Known allergies or severe reactions to the study medications or their components
    • Any medical condition that, in the opinion of the study doctor, would make it unsafe to participate in the study
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Investigated drugs

RMC-9805 is an investigational medication being studied for treating non-small cell lung cancer (NSCLC) in patients with specific RAS G12D mutations. This is a new drug that targets specific genetic changes in cancer cells. RMC-6236 is another investigational medication that works together with RMC-9805 to treat non-small cell lung cancer. It is being tested to see if the combination provides better results for patients with RAS G12D mutations. Pembrolizumab is an immunotherapy medication that helps the body's immune system fight cancer cells. It works by blocking certain proteins that can prevent immune cells from attacking cancer. The trial also includes chemotherapy medications that are commonly used to treat cancer by killing rapidly dividing cells. These medications are used in combination with the other treatments mentioned above.

What is already known about the treatment

  • RMC-9805

    An investigational drug currently being studied in clinical trials for the treatment of RAS G12D-mutated Non-Small Cell Lung Cancer (NSCLC). This novel therapeutic agent is being evaluated both as a standalone treatment and in combination with RMC-6236 and other anticancer medications, including pembrolizumab and chemotherapy agents. The drug is specifically designed to target cancers with RAS G12D mutations, representing a targeted approach to lung cancer treatment.

  • RMC-6236

    An experimental anticancer compound being tested in combination with RMC-9805 for patients with advanced RAS G12D-mutated Non-Small Cell Lung Cancer (NSCLC). This medication is part of a new generation of targeted therapies being evaluated in phase 1b/2 clinical trials, focusing on specific genetic mutations in lung cancer. The drug is being studied in various combination approaches with other cancer treatments to determine its optimal dosing and safety profile.

  • Pembrolizumab

    An established immunotherapy medication administered via intravenous infusion, used in combination with experimental drugs RMC-9805 and RMC-6236 in this clinical trial. This medication works by helping the immune system detect and fight cancer cells by blocking a protein called PD-1, and it is already approved for various types of cancer treatment. The drug belongs to the class of immune checkpoint inhibitors and has shown significant effectiveness in treating various types of lung cancer.

Investigated diseases

Lung Cancer - A disease that begins in the lungs when cells grow out of control and form tumors. It typically starts in the cells lining the bronchi and parts of the lung such as the bronchioles or alveoli. The abnormal cells continue to grow and can spread to nearby tissues or other parts of the body. Lung cancer often develops slowly over many years, with changes occurring in the lung tissue before actual tumors form. Early in the disease, people may not notice any symptoms as the changes are happening at a cellular level. As the disease progresses, it can cause breathing difficulties, persistent cough, and changes in breathing patterns.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521147-21-00Protocol codeRMC-LUNG-101CEstimated enrolment216 patientsSponsorRevolution Medicines Inc.

sourced from the EU Clinical Trials Register and site verification

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