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Study comparing RMC-6236 and docetaxel in previously treated patients with advanced or metastatic non-small cell lung cancer who have RAS mutations

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial focuses on non-small cell lung cancer (NSCLC) that has spread to other parts of the body or is in an advanced stage. The study will test two different treatments: a new medication called RMC-6236, which comes as tablets taken by mouth, and docetaxel, which is given through an intravenous infusion (through a vein).

The study aims to compare how well RMC-6236 works compared to docetaxel in treating patients whose cancer has a specific genetic change called RAS mutation. These are changes in genes that can affect how cancer grows and responds to treatment. The study is specifically designed for patients who have already received previous cancer treatments.

During the study, patients will be randomly assigned to receive either RMC-6236 tablets daily or docetaxel infusions. The treatment may continue for up to 20 months, depending on how well the patient responds to the medication and whether any side effects occur. The study will track how the cancer responds to treatment and how long patients live without their cancer getting worse.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial qualification

    Your doctor will verify if you meet the study requirements, including confirmation of non-small cell lung cancer that is either locally advanced or has spread to other parts of the body

    A test will confirm if your cancer has specific RAS mutations (changes in genes called KRAS, NRAS, or HRAS)

    Your overall health status and organ function will be evaluated

  2. Step 2

    Random assignment to treatment

    You will be randomly assigned to receive either RMC-6236 tablets or docetaxel through intravenous infusion

    The assignment is done by chance, similar to flipping a coin

  3. Step 3

    Treatment period - RMC-6236 group

    If assigned to RMC-6236, you will take tablets by mouth

    Regular visits will monitor your health and cancer status

  4. Step 4

    Treatment period - Docetaxel group

    If assigned to docetaxel, you will receive the medication through an intravenous line

    Regular visits will monitor your health and cancer status

  5. Step 4

    Monitoring period

    Your cancer will be regularly assessed using imaging scans to check if the treatment is working

    The study will track how long the treatment keeps your cancer from growing

    Your overall health status will be monitored throughout the study period

  6. Step 5

    Study completion

    The study continues until your cancer shows growth or your doctor determines you should stop treatment

    The overall study is planned to run from August 2025 to December 2030

Who can join the trial?

9 criteria

  • Must be at least 18 years old and willing to give informed consent
  • Have an ECOG performance status of 0 or 1 (able to carry out normal activities with minimal or no limitations)
  • Have a confirmed diagnosis of non-small cell lung cancer that is either locally advanced or has spread to other parts of the body, and cannot be treated with surgery or radiation therapy
  • Have tumors that can be measured using standard imaging techniques (RECIST v1.1)
  • Have normal functioning of vital organs including: - Bone marrow - Liver - Kidneys - Blood clotting system
  • Have received one to two previous treatments including: - Immunotherapy (anti-PD-1/PD-L1 treatment) - Platinum-based chemotherapy
  • Have a confirmed RAS mutation in specific genes (KRAS, NRAS, or HRAS) at particular locations (positions 12, 13, or 61)
  • Be able to take medications by mouth
  • Both men and women may participate in this study

Who cannot join the trial?

14 criteria

  • Patient has not been diagnosed with non-small cell lung cancer
  • Patient has known brain metastases (cancer that has spread to the brain) that are untreated or unstable
  • Patient has received immunotherapy treatment in the past 28 days
  • Patient has severe heart problems, including heart failure or uncontrolled high blood pressure
  • Patient has active infections requiring systemic treatment (medications that affect the whole body)
  • Patient is pregnant or breastfeeding
  • Patient has other types of cancer that require active treatment
  • Patient has severe liver problems or abnormal liver function tests
  • Patient has severe kidney problems or abnormal kidney function tests
  • Patient is currently participating in another clinical trial
  • Patient has had major surgery within the past 4 weeks
  • Patient has a history of severe allergic reactions to similar treatments
  • Patient has any condition that the study doctor believes would make participation unsafe
  • Patient is unable to follow study procedures or attend scheduled visits
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Investigated drugs

  • RMC-6236

    is an investigational drug being studied for the treatment of lung cancer in patients with specific RAS mutations. It is a targeted therapy designed to work specifically in patients whose cancer has certain genetic characteristics.

  • Docetaxel

    is a chemotherapy medication commonly used to treat various types of cancer, including lung cancer. It works by interfering with cell division, which helps to stop cancer cells from growing and spreading. This medication is given through an intravenous (IV) infusion in a hospital or clinic setting.

What is already known about the treatment

  • RMC-6236

    An investigational drug being studied in clinical trials for the treatment of non-small cell lung cancer (NSCLC), specifically targeting patients with RAS mutations. The medication is being evaluated in comparison to docetaxel in patients who have previously received treatment for locally advanced or metastatic disease. While the specific mechanism of action targets RAS mutations, which are known drivers of tumor growth, the complete details of its molecular functioning are still under investigation through clinical trials.

  • Docetaxel

    A chemotherapy medication administered intravenously that belongs to the taxane family of drugs, commonly used to treat various types of cancer, including non-small cell lung cancer. It works by disrupting cell division by binding to and stabilizing microtubules, which ultimately leads to cell death. The medication is well-established in cancer treatment protocols and is often used as a second-line therapy for patients who have previously received other treatments.

Investigated diseases

Non-small cell lung cancer – A type of lung cancer that begins in the cells lining the airways and air sacs of the lungs. It develops when cells in the lungs begin to grow abnormally and uncontrollably, forming tumors that can spread to nearby tissues. The disease typically progresses gradually, starting in one area of the lung and potentially spreading to other parts of the body. This cancer type accounts for the majority of all lung cancer cases and can affect both smokers and non-smokers. The condition can develop in different parts of the lung tissue and may cause changes in breathing patterns and chest discomfort.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518154-16-00Protocol codeRMC-6236-301Estimated enrolment590 patientsSponsorRevolution Medicines Inc.

sourced from the EU Clinical Trials Register and site verification

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