Study of Efficacy 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 research study is testing a new medicine, JDQ443, for people diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC). Doctors are focusing on patients whose cancer has a specific genetic change, known as a KRAS G12C mutation. The study will also look at other features of the cancer, like the levels of a protein called PD-L1 and another genetic change called STK11, to see how well JDQ443 works and if it's safe as the first treatment. It's a Phase 2 study, which means it builds on earlier research to gather more information about the treatment's effects. The aim is to understand if JDQ443 can shrink the cancer and help patients, while also monitoring for any side effects.
At a glance
Results
Results from this study
Posted October 2025Results have been published for this study.
What is this study about?
This study is investigating a new medication called JDQ443 for individuals dealing with a type of lung cancer known as non-small cell lung cancer (NSCLC). This isn't just for any NSCLC; it's specifically for cases where the cancer cells have a particular fault in their genetic code, called a KRAS G12C mutation. Researchers are also paying close attention to other features of the cancer, such as how much of a protein called PD-L1 is present, and if there's another genetic change known as an STK11 co-mutation. These details help doctors understand if a particular treatment might be more effective for certain patients.
The main goal of this study is to see how well JDQ443 works as the very first treatment for these specific types of lung cancer. The doctors want to find out if it can help shrink the cancer or stop it from growing, and if it's safe for people to take. Because it's a Phase 2 study, it means that the medicine has already undergone some earlier testing and this phase aims to gather more detailed information about its effectiveness and safety in a larger group of people with the specific cancer type.
By taking part, you would be helping doctors learn more about this particular form of lung cancer and a potential new way to treat it. This kind of research is vital for improving future care and options for patients. The study is very careful to collect information on how patients respond and whether they experience any side effects, ensuring that any new treatment is thoroughly understood.
Key takeaways
- This study is for a specific type of advanced non-small cell lung cancer with a KRAS G12C gene change.
- It's testing a new medicine, JDQ443, as the first treatment.
- Doctors will check how well the medicine works and if it has side effects.
- Eligibility depends on your cancer's specific genetic features and your general health.
- Participation involves regular clinic visits and taking the study medicine.
- You can stop participating at any time if you wish.
Who may be eligible?
To be considered for this study, you would need to have non-small cell lung cancer that has either spread to nearby areas or to other parts of your body, and which hasn't been treated with other systemic medicines yet. Your cancer must also have a specific genetic change called a KRAS G12C mutation.
Depending on the levels of a protein called PD-L1 and whether your cancer also has an STK11 genetic change, you would fit into one of two groups within the study. You must be well enough to carry out most daily activities, be able to swallow study medication, and not have certain other serious health issues, particularly those affecting the brain or conditions that make you very sensitive to light.
There are also reasons why you might not be able to join. For example, if your cancer has other specific genetic changes (like EGFR or ALK), or if you've already had treatment for this type of advanced lung cancer. You also couldn't take part if you're on medications that would interfere with the study drug, or if you've previously taken a similar type of KRAS G12C inhibitor. The doctors running the study will check all these details carefully to see if this study is suitable 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.
- Do I have advanced non-small cell lung cancer?
- Has my cancer been tested and found to have a KRAS G12C gene change?
- Have I already received other systemic treatments for my advanced lung cancer?
- Am I generally well enough to perform most daily activities?
- Do I have other specific genetic changes in my cancer (like EGFR or ALK)?
What does participation involve?
If you join this study, you would be taking the medicine JDQ443. Each cycle of treatment lasts about 21 days, and you would start taking the medication on the first day of the first cycle. You'd likely have regular visits to the clinic for check-ups, where doctors would monitor how you're responding to the treatment and look for any side effects. This involves various tests and assessments to see how the cancer is reacting to the medicine.
The study would continue until certain events happen. This could be completing all planned study visits, if you decide to withdraw, or if doctors decide to end your participation for medical reasons. If another study becomes available that offers JDQ443, you might be moved to that study to continue your treatment. Your safety and well-being are the top priority throughout the study.
Potential risks and benefits
Locations (45)
- The Brown University Oncology GroupVerified postcodeProvidence, United States
- Novartis Investigative SiteVerified postcodePilar, Argentina
- Novartis Investigative SiteVerified postcodeBuenos Aires, Argentina
- Novartis Investigative SiteVerified postcodeCórdoba, Argentina
- Novartis Investigative SiteVerified postcodeCórdoba, Argentina
- Novartis Investigative SiteVerified postcodeFeldkirch, Austria
- Novartis Investigative SiteVerified postcodeWels, Austria
- Novartis Investigative SiteVerified postcodeSint-Niklaas, Belgium
- Novartis Investigative SiteVerified postcodeRoeselare, Belgium
- Novartis Investigative SiteVerified postcodeSalvador, Brazil
- Novartis Investigative SiteVerified postcodeBelo Horizonte, Brazil
- Novartis Investigative SiteVerified postcodeRio de Janeiro, Brazil
Common questions
What is non-small cell lung cancer (NSCLC)?
It's the most common type of lung cancer. This study focuses on advanced NSCLC where the cancer has spread.
What is a KRAS G12C mutation?
It's a specific change in the genes of your cancer cells. Doctors check for this to see if certain new medicines might work.
What does 'first-line treatment' mean?
It means this medicine would be the first treatment you receive for your advanced lung cancer, rather than a treatment given after others have been tried.
What is a 'Phase 2 study'?
Phase 2 studies continue to check if a new medicine is safe and find out more about how well it works for a specific condition.
Will I get a placebo (dummy drug) in this study?
No, this study is 'single-arm,' meaning everyone taking part will receive the active study medicine, JDQ443.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.