RecruitingPHASE3INTERVENTIONAL

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

This research study, called RASolve 301, is looking at a new treatment called daraxonrasib for people living with advanced non-small cell lung cancer (NSCLC). This specific type of lung cancer has a change in the RAS gene. The study aims to see if daraxonrasib is a safer and more effective option than the standard chemotherapy drug, docetaxel. Participants will be randomly assigned to receive either the new drug or docetaxel. The researchers want to find out if daraxonrasib can help people live longer without their cancer getting worse, or even help them live longer overall. This is a Phase 3 study, meaning it's one of the final stages of testing before a new drug might become widely available.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Revolution Medicines, Inc.

Enrolment target

590

Start

06 May 2025

Estimated completion

01 Dec 2030

NSCLC (Non-small Cell Lung Cancer)Non-Small Cell Lung Cancer NSCLC NSCLC (Non-small Cell Lung Carcinoma)NSCLC (Advanced Non-small Cell Lung Cancer)

What is this study about?

This study is particularly for people with a common type of lung cancer called non-small cell lung cancer (NSCLC) that's considered advanced, meaning it's spread or can't be removed by surgery. The focus is on those whose cancer has a specific change (mutation) in something called the RAS gene. Researchers are testing a new drug, daraxonrasib, which works by targeting this RAS gene change. This new drug is being compared to an established chemotherapy treatment called docetaxel.

The main goal is to find out if daraxonrasib can help people live longer without their cancer progressing, or even help them live longer overall, compared to docetaxel. This is important because it could offer a new and potentially better treatment option for patients who have already had other treatments. The study is global, which means it involves people from different countries, and it's 'open-label,' meaning both you and your study doctor will know which treatment you are receiving.

Taking part in a study like this helps doctors understand if new treatments are safe and effective. The results of this study could change how this specific type of lung cancer is treated in the future, potentially offering more hope and better outcomes for patients.

Key takeaways

Tests a new drug for advanced lung cancer with a specific genetic change.
Compares the new drug to standard chemotherapy, docetaxel.
Aims to improve how long people live without their cancer getting worse, or their overall survival.
Open to patients who have already received previous treatments.
Participation is voluntary; you can withdraw at any time.
Could help find new treatment options for this type of lung cancer.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and have a confirmed diagnosis of advanced non-small cell lung cancer that has a specific change (mutation) in the RAS gene. Your cancer should have been treated before with at least one type of immunotherapy and platinum-based chemotherapy. You would also need to be well enough to take part in the study activities, which your doctor would assess based on your overall health and how well your major organs are working. Importantly, your cancer should be measurable, meaning doctors can track its size.

There are also some reasons why you might not be able to join. For example, if you've already had certain treatments that target the RAS gene or docetaxel chemotherapy, or if your cancer has spread to your brain and it hasn't been treated. Other reasons include having serious heart or lung conditions, or being pregnant or breastfeeding. You would also need to be able to take medicines by mouth.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have advanced non-small cell lung cancer with a RAS gene mutation?
Have you already had at least one immunotherapy and platinum-based chemotherapy?
Are you generally well enough for a clinical study (your doctor will check this)?
Can you take medicines by mouth?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to receive either the new drug, daraxonrasib, or the standard chemotherapy, docetaxel. This random assignment is like flipping a coin to ensure a fair comparison. Both you and your doctor will know which treatment you are getting. You'll have regular visits to the clinic for assessments, which will include blood tests, scans to check your cancer, and discussions about how you're feeling and any side effects you might be having. The specific schedule of visits and treatments will be explained in detail by the study team. You'll continue with the treatment and follow-up for as long as it's helping you and you're not experiencing severe side effects, or until the study concludes. The total duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Participating in this study might offer you access to a new, promising drug before it's widely available, which could potentially improve your health or extend your life. However, there's no guarantee the new drug will be better than the standard treatment. All medical treatments carry potential risks, including side effects, which the study team will monitor closely. You will be told about all known possible risks of both treatments before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (143)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Alabama Oncology
Verified postcode
Birmingham, United States· Recruiting
MemorialCare Long Beach Medical Center
Verified postcode
Long Beach, United States· Recruiting
Yale University, Smillow Cancer Center
Verified postcode
New Haven, United States· Recruiting
Florida Cancer Specialists & Research Institute - South
Verified postcode
Fort Myers, United States· Recruiting
BRCR Global
Verified postcode
Plantation, United States· Recruiting
Cancer Care Centers of Breevard
Verified postcode
Rockledge, United States· Recruiting
Florida Cancer Specialists & Research Institute - North
Verified postcode
St. Petersburg, United States· Recruiting
Cleveland Clinic Martin North
Verified postcode
Stuart, United States· Recruiting
Florida Cancer Specialists & Research Institute - East
Verified postcode
West Palm Beach, United States· Recruiting
University Cancer and Blood Center
Verified postcode
Athens, United States· Recruiting
Piedmont Healthcare, Inc
Verified postcode
Atlanta, United States· Recruiting
Center for Care and Discovery
Verified postcode
Chicago, United States· Recruiting

Common questions

What is Non-Small Cell Lung Cancer (NSCLC)?

NSCLC is the most common type of lung cancer. This study focuses on advanced NSCLC with specific genetic changes.

What is a RAS mutation?

A RAS mutation is a specific change in a gene that can cause cells to grow abnormally, leading to cancer. This study is for people with NSCLC who have this particular change.

What does 'randomised' mean in a study?

Randomised means that participants are put into treatment groups by chance, like drawing names from a hat. This helps ensure a fair comparison between the new drug and standard treatment.

What is a Phase 3 study?

A Phase 3 study is one of the final stages of testing a new drug. It compares the new treatment to standard options to confirm its effectiveness and safety in a larger group of people.

Can I stop participating in the study if I want to?

Yes, your participation is completely voluntary. You can decide to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Revolution Medicines Study Director

medinfo@revmed.com 1-844-2-REVMED Official trial record

Always speak to your GP or specialist before deciding to take part in a study.