Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status
This research is investigating a new medication, adagrasib, for people with advanced non-small cell lung cancer (NSCLC) that carries a particular genetic change called KRASG12C. The study is especially interested in how adagrasib helps patients who are aged 70 or older, or those who have had some challenges with their health previously. The main goal is to see if adagrasib can shrink the tumours in these patients. Participants will take the drug twice a day until their cancer gets worse or side effects become too much. This is an important step to understand if adagrasib could be a good treatment option for a wider range of patients with this type of lung cancer.
At a glance
What is this study about?
This clinical trial, called ADEPPT, is exploring a new medicine named adagrasib for a specific type of advanced lung cancer, known as non-small cell lung cancer (NSCLC) Stage IV. What makes this study unique is its focus on patients whose cancer has a particular genetic change called KRASG12C. This genetic change can make cancer grow and spread, and treatments that specifically target it are very important.
The main aim of the study is to understand how well adagrasib can shrink tumours in patients with this specific lung cancer. Researchers are particularly interested in two groups of patients: those who are 70 years of age or older, and those who might have other health conditions that affect their general wellbeing. By studying these groups, the researchers hope to learn if adagrasib can be a safe and effective treatment for a broader range of people living with this cancer.
Adagrasib is given as a pill twice a day. The study will look closely at how patients respond to the treatment, including whether their tumours get smaller. This information will help doctors understand if adagrasib could become another valuable treatment option for people with KRASG12C-mutant NSCLC, especially for those who might not have many other treatment choices.
Key takeaways
- Targets specific advanced lung cancer (NSCLC with KRASG12C genetic change).
- Investigates a new drug called adagrasib.
- Specifically includes older patients (70+) or those with pre-existing health challenges.
- Aims to shrink tumours and improve outcomes.
- Involves taking pills twice daily with regular hospital visits.
- Potential for new treatment option, but also potential side effects.
Who may be eligible?
To join this study, you must have advanced non-small cell lung cancer (Stage IV) with a specific genetic change called KRASG12C. Your doctor will have already checked for this. You should also have tried at least one other cancer treatment before. You need to be at least 18 years old, and the study is particularly looking for people aged 70 or older, or those who have some health challenges that mean they aren't quite as active as they used to be.
There are also some general health checks. You need to be expected to live for at least 12 more weeks, and your body's organs like your blood, kidneys, and liver need to be working well enough. If you can get pregnant, you'll need to use reliable contraception throughout the study, and have a negative pregnancy test before starting.
You cannot join if you've already had a similar drug that targets KRASG12C, or if you've recently been in another drug trial. You also can't participate if you have untreated cancer spread to your brain or the lining around it, or if you have certain serious heart problems or stomach issues that might stop you from taking the medication properly.
- Do I have advanced non-small cell lung cancer with a KRASG12C genetic change?
- Have I tried at least one other cancer treatment already?
- Am I aged 70 or older, or do I have some existing health conditions that affect my activity levels?
- Am I willing and able to take pills twice a day?
- Are my kidneys, liver, and blood counts generally working well?
- Do I have any serious heart problems or untreated cancer spread to my brain?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join the ADEPPT study, you will take the study drug, adagrasib, as a pill twice a day. This will continue until your cancer starts to grow again, or if you experience side effects that make it too difficult to continue. You will have regular visits to the clinic to check on your health and how the treatment is working. This will involve physical exams, blood tests, and scans to see if your tumour has shrunk. The study team will monitor you closely for any side effects and to make sure you are managing your treatment well. The total length of your participation will depend on how you respond to the treatment and your overall health, and you would need to be able to attend all scheduled appointments.
Potential risks and benefits
Locations (22)
- Instiute Jules BordetBrussels, Belgium
- Centre Hospitalier d'AvignonAvignon, France
- Caen - CHUCaen, France
- Le Mans - CHGLe Mans, France
- Hôpital de MarseilleMarseille, France
- Beaumont HospitalDublin, Ireland
- St James's HospitalDublin, Ireland
- University Hospital LimerickLimerick, Ireland
- University Hospital WaterfordWaterford, Ireland
- Fondazione IRCCS Policlinico S. MatteoPavia, Italy
- Santa Maria della Misericordia HospitalPerugia, Italy
- Istituto Nazionale Tumori "Regina Elena"Rome, Italy
+10 more sites — see the official record for the full list.
Common questions
What is KRASG12C-mutant NSCLC?
It's a specific type of advanced lung cancer that has a particular genetic fault (a change in the KRAS gene) that makes the cancer grow. This study is for people with this exact genetic change.
What is adagrasib?
Adagrasib is a study drug being tested as a treatment for advanced lung cancer with the KRASG12C genetic change. It's designed to specifically target this faulty gene.
Why is the study focusing on older patients or those with poorer health?
Researchers want to understand if adagrasib can be a safe and effective treatment option for a wider range of patients, including those who are older or have other health conditions that might make them more sensitive to treatments.
Will I get a placebo (dummy drug)?
No, this study is 'single-arm,' which means all participants will receive adagrasib. There is no placebo group in this trial.
How long will I be in the study?
Participation continues as long as the treatment is helping you and you are not having unmanageable side effects. This varies for each person.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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