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Study of RMC-6291 and Pembrolizumab with or without Chemotherapy for Patients with Advanced KRAS G12C Mutated Lung Cancer

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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 cancer known as lung cancer, specifically in patients with a certain genetic change called the KRAS G12C mutation. The study will explore the effects of a new treatment called RMC-6291, which will be used in combination with another medication called pembrolizumab. Pembrolizumab is a type of medicine that helps the immune system fight cancer. In some cases, the treatment may also include chemotherapy, which is a common cancer treatment that uses drugs to kill cancer cells.

The purpose of this study is to evaluate how safe and tolerable the combination of these treatments is for patients with advanced solid tumors that have the KRAS G12C mutation. The study will involve patients who have previously received cancer treatment and have at least one tumor that can be measured. Participants will receive the treatment over a period of time, and their health will be closely monitored to observe any side effects and how their body responds to the treatment.

Throughout the study, researchers will collect information on the levels of RMC-6291 in the blood and assess the overall response of the tumors to the treatment. The study aims to provide valuable insights into the potential benefits and risks of using RMC-6291 in combination with pembrolizumab and chemotherapy for treating lung cancer with 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, the patient will be informed about the trial's purpose and procedures. The patient will be required to sign an informed consent form, confirming their understanding and willingness to participate.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the presence of a KRAS mutation in the tumor and ensuring adequate organ function.

  3. Step 3

    Treatment phase

    The patient will receive a combination of medications, including RMC-6291 and pembrolizumab. These medications are administered as a solution for infusion.

    Depending on the specific protocol, the patient may also receive chemotherapy drugs such as cisplatin, carboplatin, or pemetrexed. These are also given as solutions for infusion.

    The frequency and duration of administration will be determined by the study protocol and the patient's response to treatment.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, the patient will be closely monitored for any side effects or changes in health status. This includes regular laboratory tests, ECGs, and vital sign checks.

    The patient will have scheduled follow-up visits to assess the effectiveness of the treatment and to make any necessary adjustments.

  5. Step 5

    Completion of the trial

    Upon completion of the treatment phase, the patient will undergo a final assessment to evaluate the overall impact of the trial medications.

    The patient will receive information about any further steps or additional follow-up that may be required.

Who can join the trial?

5 criteria

  • Must be at least 18 years old and have signed the Informed Consent Form, which is a document that explains the study and confirms your agreement to participate.
  • Must have a solid tumor with a specific change in the KRAS gene, known as a mutation.
  • Must have received cancer treatment before.
  • Must have at least one tumor lesion, which is an area of abnormal tissue, that can be measured by doctors.
  • Must have adequate organ function, meaning your bone marrow, liver, and kidneys are working well enough.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than the specific one being studied.
  • Patients who have not been diagnosed with the specific genetic mutation called KRAS G12C, which is a change in a gene that can affect cancer growth.
  • Patients who are not within the age range specified for the study.
  • Patients who are unable to follow the study procedures or take the study medications as required.
  • Patients who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a recent major surgery or are recovering from a major surgery.
  • Patients who have had a recent infection that requires treatment with antibiotics or other medications.
  • Patients who have a history of allergic reactions to the study medications or similar drugs.
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Investigated drugs

  • RMC-6291

    is an investigational medication being studied for its potential to treat certain types of cancer. It is specifically being tested in patients with solid tumors that have a specific genetic mutation known as KRAS G12C. The role of RMC-6291 in the trial is to assess its safety and how well it is tolerated by patients when used in combination with other treatments.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It is used in this trial to see how well it works with RMC-6291 in treating patients with KRAS G12C-mutated solid tumors. Pembrolizumab is already used in various cancer treatments and is known for its role in helping the body's immune system recognize and attack cancer cells.

  • Chemotherapy

    refers to a group of cancer treatments that use powerful drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy may be used alongside RMC-6291 and pembrolizumab to evaluate the combined effect on patients with KRAS G12C-mutated solid tumors. The goal is to determine if adding chemotherapy improves the treatment outcomes.

What is already known about the treatment

  • RMC-6291

    This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating lung cancer, specifically in patients with KRAS G12C-mutated solid tumors. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication is for advanced solid tumors with the KRAS G12C mutation. RMC-6291 works by targeting and inhibiting the KRAS G12C protein, which is involved in cell growth and division, thereby potentially slowing down or stopping the growth of cancer cells. It is classified as a targeted cancer therapy.

  • Pembrolizumab

    This medication is administered intravenously and is well-established in medical literature as an immunotherapy used to treat various types of cancer, including lung cancer. It is approved for use in several cancer types and is being studied in combination with other treatments. The main therapeutic indication is for cancers that express certain proteins that pembrolizumab targets. It works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. Pembrolizumab is classified as a monoclonal antibody and immune checkpoint inhibitor.

Investigated diseases

Lung Cancer – Lung cancer is a disease characterized by the uncontrolled growth of abnormal cells in one or both lungs. These abnormal cells do not develop into healthy lung tissue; instead, they divide rapidly and form tumors. As the tumors grow, they can interfere with the lung's ability to provide oxygen to the bloodstream. The disease can spread to other parts of the body, a process known as metastasis. Lung cancer is often categorized into two main types: non-small cell lung cancer and small cell lung cancer, each with different growth patterns and spread rates. Symptoms may include persistent cough, chest pain, and shortness of breath.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509571-16-00Protocol codeRMC-LUNG-101AEstimated enrolment387 patientsSponsorRevolution Medicines Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).