Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
This research study, called KRYSTAL-7, is for people with advanced lung cancer that has spread (metastatic) and has a specific gene change known as KRAS G12C. It's for patients who haven't started treatment for their advanced cancer yet. The study is split into two parts. One part is testing adagrasib by itself, and also combined with another drug called pembrolizumab, to see how well they work and if they're safe. The second part compares the combination of adagrasib and pembrolizumab against pembrolizumab alone. Both drugs aim to help the body fight the cancer. The overall goal is to find better ways to treat this type of lung cancer.
At a glance
What is this study about?
This study, called KRYSTAL-7, is looking for better ways to treat a specific type of advanced lung cancer. It focuses on Non-Small Cell Lung Cancer (NSCLC) that has a particular change in a gene called KRAS G12C. This gene change can make cancer cells grow. The study is for people whose cancer has spread to other parts of the body (metastatic) or is locally advanced, and who haven't yet received treatment for their advanced cancer.
The research is testing a new drug called adagrasib. This drug is designed to specifically target the KRAS G12C gene change, essentially trying to block the signal that helps cancer grow. The study is also looking at adagrasib in combination with another established cancer drug called pembrolizumab (also known as Keytruda). Pembrolizumab works by helping your body's immune system recognise and fight cancer cells. By combining these two drugs, researchers hope to see if they can be even more effective against this type of lung cancer.
The study has two main parts. The first part (called Phase 2) helps researchers understand more about adagrasib on its own and with pembrolizumab, checking how safe they are and how well they work in different groups of patients. The second part (called Phase 3) will be a larger comparison, to see if adding adagrasib to pembrolizumab is better than just having pembrolizumab alone for certain patients. This kind of research is crucial for discovering new treatments and improving care for people with lung cancer.
Key takeaways
- This study is for advanced Non-Small Cell Lung Cancer with a specific KRAS G12C gene change.
- It tests a new drug, adagrasib, alone and with pembrolizumab.
- Participants must be newly diagnosed with advanced cancer and not have received prior treatment.
- The study aims to find more effective treatments for this type of lung cancer.
- Regular clinic visits, tests, and scans are part of participating.
- You can stop participating at any time.
Who may be eligible?
To be part of this study, you would need to have specific types of advanced Non-Small Cell Lung Cancer (NSCLC) that has either spread or is locally advanced. Your cancer must also have a particular gene change called KRAS G12C. Importantly, you shouldn't have had any prior treatment for your advanced lung cancer, including chemotherapy or other specific cancer drugs.
For some parts of the study, if your cancer has spread to your brain, this might affect whether you can join. Generally, any brain tumours should not be causing severe symptoms or need immediate treatment. Also, you shouldn't be taking high doses of steroids for brain-related symptoms. For some parts of the study, your cancer needs to be measurable, meaning doctors can track its size.
You would not be able to join this study if you have active, untreated brain tumours that are large or in sensitive areas like the brainstem. You also can't have poorly controlled seizures or if you've recently had a lot of radiation treatment to your lungs. The study is open to both men and women, generally aged 18 and older.
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 or metastatic Non-Small Cell Lung Cancer?
- Has my cancer been tested for the KRAS G12C gene change, and is it present?
- Have I received any previous treatment for my advanced lung cancer?
- If I have brain tumours, are they small, not causing major symptoms, and not needing immediate treatment?
- Am I generally healthy enough to participate in a clinical trial?
What does participation involve?
If you join this study, you will be given study drugs, either adagrasib as a tablet you take by mouth, or pembrolizumab which is given through a drip into your vein, or both. The exact combination and how often you take them will depend on which part of the study you are in. You will have regular visits to the clinic so the medical team can monitor your health, check for any side effects, and see how the treatment is working. These visits will include physical exams, blood tests, and scans (like CT or MRI scans) to measure your cancer.
You will be closely monitored throughout the treatment period. The total length of your participation will vary depending on how you respond to the treatment and the study's design. After the main treatment phase, there will be follow-up visits to continue tracking your health. It's important to remember that this is a research study, and the exact schedule of visits and tests will be explained in detail by the study team.
Potential risks and benefits
Locations (767)
- Local Institution - 007-556-AVerified postcodeGoodyear, United States· Not yet recruiting
- USOR - Arizona Oncology - Prescott ValleyVerified postcodePrescott Valley, United States· Recruiting
- Local Institution - 007-568-AVerified postcodeSafford, United States· Not yet recruiting
- Local Institution - 007-568-BVerified postcodeSafford, United States· Not yet recruiting
- Local Institution - 007-568-CVerified postcodeSafford, United States· Not yet recruiting
- Local Institution - 007-568-DVerified postcodeSafford, United States· Not yet recruiting
- Local Institution - 007-568-EVerified postcodeSafford, United States· Not yet recruiting
- Arizona Clinical Research CenterVerified postcodeTucson, United States· Recruiting
- Highlands Oncology Group - SpringdaleVerified postcodeSpringdale, United States· Recruiting
- Providence - Saint Joseph Home Health - AnaheimVerified postcodeAnaheim, United States· Recruiting
- The Oncology Institute of Hope and Innovation - Corporate OfficeVerified postcodeCerritos, United States· Recruiting
- Local Institution - 007-777Verified postcodeFountain Valley, United States· Not yet recruiting
Common questions
What is KRAS G12C?
KRAS G12C is a specific change in a gene that can make cancer cells grow. This study is for people whose lung cancer has this particular gene change.
What is adagrasib?
Adagrasib is a new drug being tested that specifically targets the KRAS G12C gene change, aiming to stop cancer growth.
What is pembrolizumab?
Pembrolizumab (Keytruda) is a drug that helps your body's own immune system fight against cancer cells.
Can I join if I've already had treatment for my lung cancer?
No, this study is for people who have not yet received any treatment for their advanced or metastatic lung cancer.
What happens if I have brain metastases?
Whether you can join depends on your specific situation. Untreated brain metastases need to be small and not in critical areas, and you shouldn't need high doses of steroids for them.
How to find out more
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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