A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
This study, called CodeBreaK 202, is for people in the UK with advanced non-small cell lung cancer (NSCLC) that carries a specific genetic change called KRAS p.G12C. It's a late-stage study (Phase 3) aiming to see which of two treatment combinations works best as the first treatment patients receive. One combination uses the drug sotorasib with standard chemotherapy, and the other uses pembrolizumab, an immunotherapy drug, also with standard chemotherapy. Researchers want to compare how long people live and how long their cancer is kept under control with each treatment. The goal is to find the most effective frontline option for this particular type of lung cancer.
At a glance
What is this study about?
This research study, CodeBreaK 202, is investigating new ways to treat a specific type of advanced lung cancer called non-small cell lung cancer (NSCLC). This particular cancer has a unique genetic change, known as a KRAS p.G12C mutation. The study is comparing two different treatment approaches that combine certain drugs with standard chemotherapy. The aim is to find out which combination works better as a first-time treatment.
The study will look at two main things: how long people live overall (overall survival) and how long their cancer is kept under control without getting worse (progression-free survival). One treatment combination involves a drug called sotorasib alongside standard chemotherapy. Sotorasib is a targeted therapy designed to block the effects of the KRAS p.G12C mutation. The other combination involves a drug called pembrolizumab, which is an immunotherapy that helps your body's immune system fight cancer, also given with standard chemotherapy.
By comparing these two combinations, researchers hope to identify a more effective treatment option for patients with this specific type of advanced lung cancer who haven't had prior systemic treatment for their advanced disease. This kind of research is crucial for advancing our understanding and developing better ways to help people living with cancer.
Key takeaways
- Compares two first-time treatments for a specific advanced lung cancer.
- Investigates sotorasib (a targeted drug) vs. pembrolizumab (immunotherapy), both with chemotherapy.
- Aims to find which treatment best controls cancer and extends life.
- Specifically for advanced non-small cell lung cancer with a KRAS p.G12C gene change.
- If eligible, you'd receive one of the two drug combinations.
Who may be eligible?
This study is looking for adults aged 18 to 100 years old, male or female, who have a specific type of advanced non-small cell lung cancer. This means your cancer must be Stage IV, or advanced Stage IIIB or IIIC. Importantly, your cancer cells must have a particular genetic change called a KRAS p.G12C mutation, and your cancer shouldn't show a lot of a protein called PD-L1.
You would not be able to join if you've already had drug treatment for your advanced lung cancer. You also need to be fit enough to take part, as measured by a doctor's assessment (your ECOG score should be 0 or 1). There are some specific conditions that would prevent you from taking part, such as certain types of mixed lung cancer, if you have very noticeable or active brain metastases, or if you can't take medicines by mouth.
Also, if you've had a heart attack recently (within 6 months), have unstable heart rhythm issues, or if your cancer has other specific genetic changes for which there's already a standard targeted treatment, you wouldn't be eligible. Lastly, if you've previously been treated with a KRAS G12C inhibitor drug, you would not be able to join this study.
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 you have advanced non-small cell lung cancer (Stage IV, or advanced IIIB/IIIC)?
- Has your cancer been tested and found to have the KRAS p.G12C genetic change?
- Have you not had any prior drug treatment for your advanced lung cancer?
- Are you generally well and able to carry out light activities?
- Do you not have any active, symptomatic brain metastases?
What does participation involve?
Taking part in this study would involve regular visits to the clinic for assessments and treatments. You would receive one of two treatment combinations: either sotorasib with chemotherapy, or pembrolizumab with chemotherapy. Both drugs are given alongside standard platinum-based chemotherapy. The treatment period would continue as long as your cancer is responding and you are tolerating the treatment well. You'd have regular scans and blood tests to monitor your health and how the treatment is working. There would also be follow-up appointments after your treatment finishes to track your health over time. The total duration of your participation would depend on how your cancer responds to treatment.
Potential risks and benefits
Locations (383)
- Sansum ClinicVerified postcodeSanta Barbara, United States· Recruiting
- Medical Oncology Hematology Consultants Helen F Graham Cancer CenterVerified postcodeNewark, United States· Recruiting
- University of Illinois ChicagoVerified postcodeChicago, United States· Recruiting
- Illinois Cancer SpecialistsVerified postcodeNiles, United States· Recruiting
- Norton Cancer Institute - BrownsboroVerified postcodeLouisville, United States· Completed
- Reliant Medical Group IncVerified postcodeWorcester, United States· Recruiting
- University of New Mexico Cancer CenterVerified postcodeAlbuquerque, United States· Recruiting
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Terminated
- Messino Cancer Centers AshevilleVerified postcodeAsheville, United States· Recruiting
- Duke University Medical CenterVerified postcodeDurham, United States· Recruiting
- FirstHealth Cancer CenterVerified postcodePinehurst, United States· Recruiting
- Alliance Cancer Specialists - MediaVerified postcodeMedia, United States· Recruiting
Common questions
What does 'non-small cell lung cancer' mean?
It's the most common type of lung cancer. This study focuses on a specific kind that has a genetic change called KRAS p.G12C.
What is chemotherapy?
It's a common type of cancer treatment that uses powerful drugs to kill fast-growing cells in the body, including cancer cells.
What are sotorasib and pembrolizumab?
Sotorasib is a targeted drug that blocks a specific faulty gene (KRAS p.G12C). Pembrolizumab is an immunotherapy that helps your immune system fight the cancer.
What does 'front-line therapy' mean?
This means it's the first treatment you receive for your advanced lung cancer, rather than a treatment given after others have been tried.
Will I know which treatment I'm getting?
In this type of study, participants are usually assigned to one treatment group or the other randomly, and sometimes neither you nor your doctor will know which one it is (this is called 'blinding'). Your study team will explain this to you.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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