KontRASt-02: A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer.
This study, called KontRASt-02, tests whether a new targeted medicine called JDQ443 is more effective than a standard chemotherapy drug called docetaxel. It is designed for adults with advanced non-small cell lung cancer that has spread or cannot be removed with surgery. To take part, patients must have a specific fault in their tumour's genes known as the KRAS G12C mutation, and their cancer must have grown after previous cancer therapies. Participants are placed into one of two treatment groups by chance (randomly). One group receives the new daily tablet JDQ443, while the other receives docetaxel through a drip. Doctors will carry out regular scans, blood tests, and heart checks to measure how well the treatments work at holding back tumour growth, while carefully tracking any side effects.
At a glance
What is this study about?
Lung cancer is one of the most common cancers in the UK. Non-small cell lung cancer is the most frequent type. In some people, the cancer cells carry a faulty gene called KRAS G12C. This genetic fault acts like a broken switch that stays turned on, sending non-stop signals that make the tumour grow and spread.
Standard treatments, such as standard chemotherapy and immunotherapy, can help for a while, but the cancer often begins to grow again. When this happens, doctors usually offer a chemotherapy drug called docetaxel. While docetaxel can be helpful, researchers are searching for smarter treatments that attack cancer cells more directly while causing fewer general side effects.
This Phase 3 trial compares a new targeted medicine, JDQ443, directly against docetaxel. JDQ443 is designed to switch off the faulty KRAS G12C protein specifically. By comparing the two treatments, researchers hope to see whether the new drug keeps cancer from growing for longer and whether it offers a better quality of life.
Key takeaways
- A Phase 3 trial comparing a new targeted drug (JDQ443) with standard chemotherapy (docetaxel).
- Open to adults with advanced non-small cell lung cancer that carries the KRAS G12C mutation.
- Designed for people whose cancer has progressed after previous cancer treatments.
- Participants are assigned to one of the two treatments by chance.
- Participation involves regular hospital visits, blood tests, and imaging scans.
- Taking part is completely voluntary and you can leave the study at any time.
Who may be eligible?
You may be able to join this study if you are 18 or older and have been diagnosed with advanced or metastatic non-small cell lung cancer. 'Advanced' means the cancer has spread to nearby tissue or other parts of the body and cannot be completely cleared with surgery or radiotherapy.
Your tumour must have been tested and shown to have the specific KRAS G12C genetic mutation. You must also have already received standard cancer treatment (such as chemotherapy or immunotherapy) that has stopped working.
You might not be able to take part if you have certain other serious medical conditions, such as severe heart problems, active infections, or if you cannot attend regular hospital appointments. Your hospital oncology team will carry out detailed checks to make sure the trial is safe for you.
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.
- I am aged 18 or over.
- I have been diagnosed with advanced or metastatic non-small cell lung cancer.
- My cancer has been confirmed to have the KRAS G12C mutation.
- I have already had at least one prior treatment for my lung cancer.
- I am well enough to attend regular hospital check-ups and follow-up scans.
What does participation involve?
If you take part, you will be placed into one of two groups by chance, like flipping a coin. You cannot choose your group. One group will take JDQ443, usually as daily tablets at home. The other group will receive standard docetaxel chemotherapy, given through a drip into a vein at the hospital once every three weeks.
You will need to visit the hospital regularly for check-ups. These visits will include regular imaging scans (such as CT or MRI scans) to check tumour size, blood tests, physical examinations, and heart tracings (ECGs). You will stay on your assigned treatment for as long as it continues to help you and the side effects remain manageable. If you stop the treatment, the study team will continue to check in on your health over time.
Potential risks and benefits
Locations (9)
- —UnverifiedRomania
- —UnverifiedPortugal
- —UnverifiedSlovenia
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedFinland
- —UnverifiedItaly
- —UnverifiedIceland
- —UnverifiedGreece
Common questions
Can I choose which treatment I receive?
No. A computer system assigns you to either JDQ443 or docetaxel by chance. This ensures the study results are fair and unbiased.
How do I know if my tumour has the KRAS G12C mutation?
Your doctor can tell you if your tumour has this mutation based on lab tests done on a previous tissue sample (biopsy) or a blood test.
Will taking part cost me anything?
No. The trial medication, extra tests, and hospital appointments are provided free of charge, and some trials help with travel expenses.
What happens if my cancer gets worse during the study?
Your team will do regular scans. If tests show the treatment is no longer working, you will stop taking it and your doctor will discuss other treatment options with you.
Can I leave the study if I change my mind?
Yes. You are free to withdraw from the trial at any point, and your usual NHS cancer care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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