Contact an Amgen Medical Information Healthcare Professional to learn about ongoing clinical trials.
Why is the CodeBreaK 201 clinical trial being done?
The purpose of the CodeBreaK 201 clinical trial is to evaluate the effectiveness and safety of a study drug known as sotorasib. The study includes patients with non-small cell lung cancer (NSCLC) whose tumors have the KRAS G12C mutation. The NSCLC in these patients has spread to other parts of the body (stage 4, metastatic).
CodeBreaK 201: Lung Cancer
NCT04933695
If you’re interested in the CodeBreaK clinical trial, you can print this page and show it to your doctor or give the above clinical trial reference number to your doctor.
Who can participate?
A study doctor will determine the eligibility of each potential participant. If you fit the profile below, the CodeBreaK 201 clinical trial might be an option for you.
Lung Cancer
Patients diagnosed with non-small cell lung cancer (NSCLC) that has spread to other parts of the body (stage 4, metastatic) and who have not yet received any treatments for this specific disease stage
KRAS G12C Mutation
Patients whose NSCLC has the KRAS G12C mutation
Age
Patients who are age 18 years and older
Study participants must also meet additional eligibility criteria and be accepted to enroll in the study. For information about these criteria, please contact an Amgen Medical Information Healthcare Professional
How do I know if my cancer has the KRAS G12C mutation?
You may have already been tested for genetic mutations related to cancer. You can ask your doctor about this testing, which is called biomarker testing, to determine if your cancer has the KRAS G12C mutation. You or your doctor can also contact us for more information.
What are the study drugs?
All CodeBreaK 201 clinical trial participants receive an active study drug—sotorasib alone—during this clinical trial.
Sotorasib (oral tablets)
- Once a day
What happens in the CodeBreaK 201 clinical trial?
If you agree to join the CodeBreaK 201 clinical trial, you will go to the study clinic for assessments of your cancer and your overall health to find out if you meet all requirements for participation.
If you meet all requirements for participation and decide to continue, you will be assigned to a study group. The study group to which you are assigned will determine the dose of sotorasib you will receive. Both you and your doctor will know which dose of sotorasib you should take.
CodeBreaK 201 is a Phase 2 clinical trial.
- About 170 study participants around the world will be enrolled for this trial
Screening period (up to 4 weeks)
- Attend a screening visit to provide medical history
- Have medical testing and evaluation done, possibly including a biopsy, to see if you meet the requirements for participating in the CodeBreaK 201 clinical trial
Study treatment period*
- Receive sotorasib alone
- Attend study appointments and get imaging to monitor how your disease is responding to treatment
*The length of time for which you receive treatment will vary depending on how you respond to treatment.
Long-term follow up period (up to 5 years)
- Talk to the study team by phone or visit the study clinic about every 3 months
Where are the CodeBreaK clinical trial locations?
Initially, this map displays the clinical trial locations near the “internet address” of the computer you are using to view this website. Amgen will not attempt to find your location using this information. Read our privacy statement for more information about data privacy and your rights.
You can use the search field to find different locations. Additional locations may be added on an ongoing basis.
If you want more information about the CodeBreaK 201 clinical trial, finding a trial location near you, or how to enroll in a trial, contact an Amgen Medical Information Healthcare Professional.
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Where can I get more information?
If you want more information about CodeBreaK clinical trials and whether you may be eligible for one of these clinical trials, please contact an Amgen Medical Information Healthcare Professional or talk to your doctor.
