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).
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.
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.
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
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
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.
All CodeBreaK 201 clinical trial participants receive an active study drug—sotorasib alone—during this clinical trial.
Sotorasib (oral tablets)
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.
Screening period (up to 4 weeks)
Study treatment period*
*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)
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.
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.