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Study of zoldonrasib in patients with RAS G12D mutation non-small cell lung cancer who have received previous treatment

Fast replyInvestigationalNo placebo
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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 a new medication called zoldonrasib (also known as RMC-9805) in patients who have already received previous cancer treatments. This type of lung cancer occurs when cells in the lungs grow abnormally and form tumors.

The purpose of this research is to determine how well zoldonrasib works in treating patients with this specific type of lung cancer. The medication comes in tablet form and is taken by mouth. During the study, patients will receive zoldonrasib daily, with the maximum daily dose being 1200 mg. The treatment period may last up to 9 months.

Throughout the study, doctors will monitor patients' health and track how their cancer responds to the treatment. They will check the size of tumors and watch for any changes in the patient's condition. The study will also look at how long the treatment remains effective and track any side effects that may occur. Regular medical examinations and blood tests will be performed to ensure patient safety during the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your medical condition will be assessed to confirm you have non-small cell lung cancer with a specific genetic change called RAS G12D mutation

    Medical tests will check your organ function, including bone marrow, liver, and kidney function

    Your tumors will be measured to confirm at least one can be tracked during the study

  2. Step 2

    Treatment start

    You will receive zoldonrasib (RMC-9805) in tablet form

    The medication needs to be taken by mouth

    Your healthcare provider will give you specific instructions about when and how to take the tablets

  3. Step 3

    Regular monitoring

    Your tumor size will be measured regularly using imaging scans

    Blood tests will be performed to check the amount of medication in your system

    Your overall health will be monitored, including any side effects

    Laboratory tests will track changes in your blood values

    Your vital signs will be checked during visits

  4. Step 4

    Long-term follow-up

    Your progress will be tracked for at least 6-12 months

    The study team will monitor how long the treatment works

    Regular assessments will continue to check your response to the medication

    The total study duration may extend until June 2027

Who can join the trial?

10 criteria

  • Must be 18 years or older
  • Must have non-small cell lung cancer (NSCLC) with a specific genetic change called RAS-G12D mutation (a specific alteration in the DNA of cancer cells)
  • Must have either:
    • Received previous cancer treatment, or
    • Be unable to receive standard cancer treatments
    • Must have at least one measurable tumor that doctors can track to determine if the treatment is working
    • Must have proper functioning of:
      • Bone marrow (the tissue inside bones that produces blood cells)
      • Liver
      • Kidneys
      • Normal blood clotting ability
      • Both men and women can participate in this study

Who cannot join the trial?

14 criteria

  • Prior treatment with any KRAS G12D inhibitor (a type of targeted cancer therapy)
  • Active brain metastases (cancer that has spread to the brain) that are not treated and stable
  • History of another cancer within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Severe heart conditions including:
    • Heart attack within the past 6 months
    • Unstable angina (chest pain)
    • Severe heart rhythm problems
    • Severe liver problems or abnormal liver function tests
    • Known HIV, active hepatitis B, or active hepatitis C infection
    • Any serious medical condition that could interfere with study participation
    • Pregnant or breastfeeding women
    • Unable to swallow oral medications
    • Known allergies to the study medication or its components
    • Participation in another clinical trial within 30 days before starting this study
    • Any psychological, social, or medical condition that could interfere with the patient's safety or ability to provide informed consent
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Investigated drugs

Zoldonrasib (RMC-9805) is a targeted therapy medication being studied for treating non-small cell lung cancer. It specifically targets tumors with a particular genetic mutation called RAS G12D. This medication is designed to work in patients who have already received previous treatments for their cancer. It works by blocking specific cellular processes that contribute to cancer growth in tumors with this genetic mutation.

What is already known about the treatment

Zoldonrasib (RMC-9805) - An investigational oral medication specifically designed for treating non-small cell lung cancer (NSCLC) with RAS G12D mutations in patients who have previously undergone systemic therapy. This targeted therapy belongs to the class of precision oncology drugs that work by inhibiting specific mutated proteins involved in cancer cell growth and survival. The medication is currently being evaluated in Phase 2 clinical trials to assess its effectiveness in treating lung cancer patients who have already received prior treatment, with particular focus on measuring the objective response rate (ORR) using standard RECIST criteria. The drug represents a promising approach in personalized cancer treatment by specifically targeting tumors with RAS G12D mutations.

Investigated diseases

Lung Cancer - A disease that begins when abnormal cells in the lungs start to grow uncontrollably, forming tumors that can spread to other parts of the body. The lungs are two spongy organs in the chest that take in oxygen and release carbon dioxide when we breathe. This cancer can develop in any part of the lungs, but most commonly starts in the cells that line the air passages. The disease typically develops gradually, and early stages may not cause noticeable symptoms. As the condition progresses, it may cause persistent coughing, chest pain, shortness of breath, and changes in breathing patterns. Lung cancer can occur in both smokers and non-smokers, though smoking is a major risk factor.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521681-10-00Protocol codeRMC-LUNG-101DEstimated enrolment107 patientsSponsorRevolution Medicines Inc.

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