A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects with Stage IV NSCLC whose Tumors Harbor a KRASG12C Mutation in Need of First-Line Treatment (CodeBreak 201)
This study, called CodeBreak 201, is exploring a new medication named sotorasib for adults with a type of advanced lung cancer called non-small cell lung cancer. Specifically, it's for patients whose cancer has a particular genetic fault known as a KRAS G12C mutation, and who need their first treatment for this advanced stage. The main purpose is to find out how effective sotorasib is by measuring if tumors shrink or disappear. Researchers will also look at how long people live, how long they stay well without their cancer getting worse, and any side effects the medicine might have. This is a Phase 2 study, meaning it's testing safety and effectiveness in a larger group of people after initial safety checks.
At a glance
What is this study about?
This clinical trial is investigating a new medication called sotorasib for advanced non-small cell lung cancer. Non-small cell lung cancer is the most common type of lung cancer. This study focuses on a specific group of patients whose cancer cells have a particular genetic change, or 'fault', known as a KRAS G12C mutation. This mutation can make cancer grow and spread. The trial is for patients who are needing their first treatment for this advanced stage of cancer.
The main aim of the study is to see how well sotorasib works in shrinking or making the cancer disappear. Doctors will use scans like CT and MRI to measure the size of the tumors and assess if the treatment is effective. They will also be looking at other important aspects, such as how long patients live, how long they stay well without their cancer getting worse, and if the medication helps control the cancer’s growth.
Understanding how sotorasib works and its effects is very important. If this medicine proves to be safe and effective, it could offer a new treatment option for patients with this specific type of lung cancer. The information gathered from this study will help healthcare professionals make better treatment decisions in the future.
Key takeaways
- The study is about a new drug, sotorasib, for advanced lung cancer with a specific genetic change.
- It's for people needing their first treatment for advanced non-small cell lung cancer.
- The main goal is to see if the drug shrinks or makes tumors disappear.
- Participation involves regular hospital visits for tests and monitoring.
- There are potential benefits and risks, as with any new medicine.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old, with advanced non-small cell lung cancer. Your cancer must have a specific genetic change called a KRAS G12C mutation, which will be confirmed by tests. This study is for people who need their first treatment for their advanced cancer.
There are also other medical requirements that your doctor will need to check to make sure the study is a safe and suitable option for you. For example, they will review your overall health, other medical conditions you might have, and any other medications you are taking.
If you meet these main criteria, your study doctor will discuss all the detailed requirements with you to determine if you can participate.
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.
- Are you 18 years old or older?
- Do you have advanced non-small cell lung cancer?
- Has your cancer been tested and confirmed to have a KRAS G12C mutation?
- Are you needing your first treatment for this advanced stage of cancer?
- Are you able to attend regular hospital appointments for tests and check-ups?
What does participation involve?
If you decide to take part in this study, you will receive the study medication, sotorasib. You will have regular visits to the hospital or clinic, where you will undergo various tests and checks. These will include physical examinations, blood and urine tests, and imaging scans like CT or MRI, to monitor your health and how the treatment is affecting your cancer. These tests help the doctors track the size of your tumors and look for any side effects.
You will also have regular checks of your heart and vital signs, like blood pressure. The study team will explain the schedule for these visits and tests. The total duration of your participation will depend on how you respond to the treatment and your overall health, but you will be closely monitored throughout.
Potential risks and benefits
Locations (5)
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedSweden
- —UnverifiedItaly
- —UnverifiedFrance
Common questions
What is non-small cell lung cancer?
It's the most common type of lung cancer. This study focuses on an advanced stage of it.
What does 'KRAS G12C mutation' mean?
It's a specific genetic change in the cancer cells that the study medication is designed to target.
What does a 'Phase 2' study mean?
It means the study is testing safety and initial effectiveness in a larger group of patients after earlier safety tests.
Will I know if the treatment is working?
Doctors will use scans and tests to check if your tumors are shrinking or if the cancer is stable.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without it affecting your regular medical care.
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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