RecruitingPhase IIIInterventional

Phase III study of daraxonrasib (RMC-6236) in previously treated NSCLC patients with RAS mutations

This study is looking at a new medicine called daraxonrasib and comparing it to docetaxel, a common treatment for lung cancer. It's for people with a type of lung cancer called non-small cell lung cancer (NSCLC) that has a specific genetic change called a RAS mutation and has already been treated with other medicines. The main goal is to find out if daraxonrasib is more effective or safer than docetaxel. You'll be screened to see if you qualify, and then if you join, you'll either receive the new medicine or docetaxel. Doctors will monitor you closely during treatment and follow-up.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Revolution Medicines (United States)

Enrolment target

420

Start

07 May 2025

Estimated completion

01 Jan 2027

RAS mutant non-small cell lung cancer

What is this study about?

This study is designed to help people living with a form of lung cancer known as non-small cell lung cancer (NSCLC). Doctors are especially interested in patients whose cancer has a particular genetic 'fault' or change called a RAS mutation. This type of lung cancer has already been treated with certain medicines, but researchers are looking for new and potentially better options.

The main purpose of this study is to compare two treatments: a new medicine called daraxonrasib and a standard medicine called docetaxel. Docetaxel is already approved and commonly used, while daraxonrasib is still being tested to understand how well it works and if it has any new side effects. By comparing these two, researchers hope to discover which treatment might be more helpful for these specific patients.

Taking part in this study means you would be randomly assigned to receive either daraxonrasib or docetaxel. This helps ensure the comparison between the two medicines is fair. The study team will carefully monitor your health throughout the treatment and follow-up periods. Your participation could help improve future treatments for people with this type of lung cancer.

Key takeaways

This study compares a new medicine (daraxonrasib) with a standard one (docetaxel) for lung cancer.
It's for non-small cell lung cancer patients with a specific RAS gene change who've had previous treatment.
You'll be randomly assigned to one of the two treatments.
The new medicine's full side effects aren't completely known yet.
Participation involves screening, treatment, and follow-up appointments.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have non-small cell lung cancer that has spread in their body (locally advanced) or to other parts (metastatic). Your cancer must also have a specific genetic change called a RAS mutation.

To be considered, you should have already received one or two other types of treatment for your lung cancer, including an immunotherapy drug (like anti-PD-1 or anti-PD(L)-1) and a platinum-based chemotherapy. You also need to be able to take medicines by mouth and be generally well enough to take part, as assessed by the study doctors.

However, some things would mean you couldn't join. For example, if you've already had certain targeted medicines for RAS or docetaxel itself, or if your cancer has spread to your brain and isn't being treated. Other reasons might include serious heart or lung problems, being pregnant or breastfeeding, or having other genetic changes in your cancer that already have approved treatments.

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 old or older?
Do you have non-small cell lung cancer that has spread?
Has your cancer been found to have a RAS gene mutation?
Have you already received one or two other treatments for your lung cancer, including a specific immunotherapy and chemotherapy?
Are you able to take medicines by mouth?
Are you generally feeling well enough for a study like this?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is a 'pre-screening' period of up to 14 days to check if your cancer has the specific RAS mutation we're looking for. Following this, there's a 'screening' period of up to 28 days where you'll have appointments with the study doctors and undergo tests to make sure the study is right for you and you meet all the requirements. These tests might include blood tests, scans, and possibly a biopsy.

If you qualify, you'll then enter the 'treatment period'. You'll be randomly assigned to one of two groups: one group will receive the new medicine, daraxonrasib, and the other group will receive docetaxel, a standard treatment. Neither you nor your doctor will usually know which treatment you are getting. You'll take your assigned medicine and have regular check-ups, scans, and blood tests to see how you're responding and to monitor for any side effects. After the treatment period, there will be a 'follow-up period' where your health will continue to be monitored, even after you stop taking the study medicine, to see how you're doing long-term. The study is expected to run from May 2025 until December 2030, covering the entire participation of all patients.

Potential risks and benefits

Participating in this study might offer you access to a new medicine (daraxonrasib) that is currently being investigated and could potentially be more effective for your type of lung cancer than existing treatments. However, there's no guarantee of direct benefit for you. Like all medicines, both daraxonrasib and docetaxel have potential side effects. Docetaxel's side effects are well-known, but for daraxonrasib, not all possible side effects are fully understood yet as it's a newer medicine. There's a risk of allergic reactions with any treatment, which can range from mild to very serious. You may also experience common side effects like feeling tired, sickness, diarrhoea, skin problems, or changes in blood tests. Medical scans involved in the study may also have minor risks, such as exposure to a small amount of radiation, or discomfort during procedures like biopsies. You have the right to withdraw from the study at any time, for any reason, without affecting your current or future medical care.

Locations (1)

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

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Unverified
United Kingdom

Common questions

What is a 'RAS mutation'?

A RAS mutation is a specific change in the genes of your cancer cells. These changes can make cancer grow and spread, and treatments sometimes target these specific changes.

What does 'Phase III study' mean?

Phase III means this is one of the final stages of testing a new medicine. It means the medicine has already been studied in smaller groups of people and has shown some promising results.

Will I know which treatment I'm receiving?

In this study, neither you nor your doctor will typically know whether you are receiving daraxonrasib or docetaxel. This helps to ensure the results are fair and unbiased.

How long will I be in the study?

The study involves a screening period, a treatment period, and a follow-up period. The total time you'll be involved can vary for each person, but the study itself plans to run until December 2030.

Who is paying for this study?

The study is funded by Revolution Medicines, a company based in the USA, who are also running the study.

How to find out more

Colin Lindsay

colin.lindsay1@nhs.net +44 (0)161 446 ext 8125 Official trial record

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