KontRASt-06: An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with a PD-L1 expression < 1% or a PD-L1 expression ≥ 1% and an STK11 co-mutation.
This study is looking at a new targeted drug called JDQ443 for people with advanced non-small cell lung cancer. In some people, lung cancer is driven by a faulty gene called KRAS G12C. Sometimes, other markers, such as low PD-L1 levels or an STK11 gene change, can make standard treatments like immunotherapy less effective. JDQ443 is designed to block the faulty KRAS G12C protein and stop cancer cells from growing. Researchers want to find out if giving JDQ443 on its own works well as a very first treatment for people with these specific tumour markers. All participants will receive the study medicine; there is no dummy pill (placebo). Doctors will closely track tumour size, monitor side effects, and check how the body handles the drug using regular blood tests and scans.
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 recent years, doctors have discovered that many lung cancers are linked to tiny changes, or mutations, in specific genes inside the cancer cells. One of these changes is called KRAS G12C. This faulty gene acts like a broken switch, sending constant signals that tell cancer cells to multiply.
Standard treatments, such as immunotherapy, work very well for some patients, but they do not help everyone equally. For instance, if a tumour has low levels of a protein called PD-L1, or carries another mutation called STK11, standard medicines may not work as well. Doctors are searching for better first-line options for patients with these exact tumour features.
This trial is testing a new targeted drug called JDQ443. It is designed to find and switch off the faulty KRAS G12C protein directly. Because this is an 'open-label' study, everyone who takes part will receive the active study medicine. Researchers hope that targeting this gene directly will help shrink tumours and keep the cancer under control for longer, while causing manageable side effects.
Key takeaways
- Tests a new targeted tablet called JDQ443 for advanced non-small cell lung cancer.
- Designed for tumours with the KRAS G12C mutation and specific PD-L1 or STK11 features.
- Aimed at people who have not yet started treatment for their advanced cancer.
- All participants receive the active trial medicine; no one receives a placebo.
- Taking part is completely voluntary and you can withdraw at any time.
Who may be eligible?
This trial is for adults aged 18 and over who have been diagnosed with locally advanced or metastatic non-small cell lung cancer. Locally advanced means the cancer has spread into nearby tissues, while metastatic means it has spread to other parts of the body.
To take part, your tumour must have been tested and shown to carry the KRAS G12C gene mutation. In addition, your cancer must either have low levels of the PD-L1 protein (less than 1%) or have PD-L1 levels of 1% or higher alongside another specific gene change called STK11.
This study is aimed at people who have not yet had systemic treatment (such as chemotherapy or immunotherapy) for their advanced cancer. Your hospital doctor or trial team will review your previous medical history, general health, and test results to make sure it is safe for you to join.
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 the KRAS G12C gene mutation.
- My tumour has low PD-L1 levels, or higher PD-L1 with an STK11 mutation.
- I have not yet received systemic drug treatment for my advanced lung cancer.
What does participation involve?
Taking part in this study involves taking the study drug, JDQ443, as directed by the hospital team. Because this is a clinical trial, you will have more frequent hospital appointments than usual, especially during the first few months. At your visits, the research team will carry out physical examinations, check your blood pressure and heart rate, take blood samples, and perform heart traces (ECGs). You will also have regular imaging scans, such as CT or MRI scans, to see how your tumour is responding to the medicine. You can stay on the treatment for as long as it continues to help you and the side effects remain manageable. The team will continue to check on your health even after you finish taking the medicine.
Potential risks and benefits
Locations (10)
- —UnverifiedNetherlands
- —UnverifiedHungary
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedPortugal
- —UnverifiedGreece
- —UnverifiedItaly
- —UnverifiedAustria
Common questions
Will I receive a placebo (dummy drug)?
No. This is an open-label study, which means every person who joins will receive the active study drug, JDQ443.
What is a KRAS G12C mutation?
It is a specific, faulty gene change found inside some cancer cells. It tells the cancer cells to grow and multiply. It is not an inherited condition that you pass on to your children.
How do I know if my tumour has these genetic markers?
Your doctor can tell from tests done on a small piece of your tumour tissue (a biopsy) or through a specialised blood test.
Do I have to pay to take part?
No. The trial medication and all study-related tests are provided free of charge. Some trials also help cover travel expenses to the hospital.
Can I leave the study if I change my mind?
Yes, absolutely. You can leave the trial at any point, for any reason, without your regular doctors or your usual care being affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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