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Study of RMC-6236 and Pembrolizumab with or without Chemotherapy for Patients with RAS-Mutated 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 clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC) that has specific changes in the RAS gene. The study will explore the effects of a new treatment called RMC-6236, which will be used in combination with another medication called pembrolizumab. Pembrolizumab is a type of medicine that helps the immune system fight cancer. Some participants may also receive additional chemotherapy, which is a treatment that uses drugs to kill cancer cells.

The purpose of this study is to understand how safe and tolerable the combination of these treatments is for patients with advanced RAS-mutated NSCLC. The study will involve several steps over a period of time. Participants will receive the treatments and will be monitored closely by healthcare professionals. The study will look at how the body responds to the treatments and any side effects that may occur. The study will also measure the levels of RMC-6236 in the blood over time to understand how the body processes the drug.

Participants in the study will be those who have NSCLC that has spread to other parts of the body and have previously received cancer treatment. The study will help gather important information that could lead to better treatment options for people with this type of lung cancer in the future.

The research process

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

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose, which is to evaluate the safety and tolerability of the medication RMC-6236 in combination with pembrolizumab, with or without chemotherapy, for patients with advanced lung cancer with specific mutations.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes verifying the presence of specific mutations in lung cancer, ensuring the cancer has spread to other parts of the body, and confirming previous cancer treatments. Adequate organ function will also be assessed.
Step 3
Treatment phase
The treatment phase involves administering RMC-6236 orally. The exact dosage and frequency will be determined by the study protocol.
In addition, pembrolizumab will be given as a solution for infusion. The frequency and duration of this treatment will be specified in the study protocol.
Depending on the study group, chemotherapy may also be administered. This could include medications such as carboplatin, cisplatin, or pemetrexed, all given as solutions for infusion.
Step 4
Monitoring and follow-up
Throughout the trial, the patient will be monitored for any side effects or adverse reactions. This includes regular laboratory tests, ECGs, and vital sign checks.
The concentration of RMC-6236 in the blood will be measured over time to understand how the body processes the medication.
Step 5
Completion of the trial
The trial is expected to continue until January 30, 2026. Upon completion, the patient's overall response to the treatment will be evaluated, including the duration of response and any changes in tumor size.

Who can join the trial?

6 criteria

Patients must be at least 18 years old.
Patients must have a type of lung cancer called **NSCLC** with certain **RAS mutations**. **NSCLC** stands for Non-Small Cell Lung Cancer, which is a common type of lung cancer. **RAS mutations** are changes in a specific gene that can affect cancer growth.
Patients must have lung cancer that is unlikely to be cured and has spread to other parts of the body.
Patients must have received previous treatment for cancer.
Patients must have at least one **tumor lesion** that can be measured. A **tumor lesion** is an area of abnormal tissue that can be seen and measured.
Patients must have adequate organ function, meaning their bone marrow, liver, and kidneys are working well enough.

Who cannot join the trial?

9 criteria

Patients who have a different type of cancer other than lung cancer cannot participate.
Patients who do not have the specific RAS mutation in their lung cancer are excluded. A mutation is a change in the DNA that can affect how cells grow.
Patients who are not in the age range specified for the study cannot join. The study is for adults only.
Patients who are not able to understand or follow the study procedures will not be included.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have other serious health conditions that might interfere with the study treatment are excluded.
Patients who have had another cancer treatment recently that might interfere with the study treatment cannot join.
Patients who have allergies to the study drugs or similar drugs are excluded.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands
Thoraxklinik Heidelberg gGmbH
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Heidelberg, Germany
Universitair Medisch Centrum Utrecht
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Utrecht, The Netherlands

Trial locations

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Investigated drugs

RMC-6236
is an investigational medication being studied for its potential to treat patients with non-small cell lung cancer (NSCLC) that has a specific mutation known as RAS. This medication is being tested to see if it can help control the growth of cancer cells in patients with this type of mutation.
Pembrolizumab
is a type of immunotherapy that helps the body's immune system recognize and attack cancer cells. It is used in this study to see if it can work together with RMC-6236 to improve treatment outcomes for patients with RAS-mutated NSCLC.
Chemotherapy
is a treatment that uses drugs to kill cancer cells or stop them from growing. In this study, chemotherapy may be used alongside RMC-6236 and pembrolizumab to see if the combination can be more effective in treating patients with advanced RAS-mutated NSCLC.

What is already known about the treatment

RMC-6236
This medication is administered orally and is currently being studied in clinical trials for its potential use in treating lung cancer, specifically non-small cell lung cancer with RAS mutations. It is in the investigational stage, with ongoing research to determine its safety and effectiveness. RMC-6236 works by targeting and inhibiting specific proteins involved in cancer cell growth and survival, aiming to slow down or stop the progression of the disease. It is classified as a targeted therapy, focusing on molecular changes that are specific to cancer cells.
Pembrolizumab
This medication is administered through intravenous infusion and is an established treatment in the medical field, widely used for various types of cancer, including lung cancer. It is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. Pembrolizumab blocks the PD-1 pathway, which cancer cells use to hide from the immune system, thereby enhancing the body's natural defense against tumors. It is classified as an immunotherapy, a type of treatment that uses the body's immune system to fight cancer.

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 disease progresses, these tumors can interfere with the lung's ability to provide oxygen to the bloodstream. Lung cancer can spread to other parts of the body, a process known as metastasis. The disease is often categorized into two main types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC being the more common type. Symptoms may include persistent cough, chest pain, and shortness of breath, but they often appear only in advanced stages.