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.
1Initial 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
2Random 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
3aTreatment period – RMC-6236 group
If assigned to RMC-6236, you will take tablets by mouth
Regular visits will monitor your health and cancer status
3bTreatment 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
4Monitoring 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
5Study 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 Study?
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 Study?
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
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.
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.
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