A clinical trial for patients with non-small cell lung cancer (NSCLC) whose cancer has the KRAS G12C mutation

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Status

Recruiting

PHASE

Phase 3

CONDITION

Advanced non-small cell lung cancer (NSCLC)

STUDY DRUGS

sotorasib or docetaxel

Contact an Amgen Medical Information Healthcare Professional to learn about ongoing clinical trials.

Why is the CodeBreaK 200 clinical trial being done?

The purpose of the clinical trial is to evaluate the effectiveness and safety of a study drug known as sotorasib compared with docetaxel (an approved drug used to treat cancer) in previously treated patients with non-small cell lung cancer (NSCLC) containing the KRAS G12C mutation.

Study to compare sotorasib with docetaxel in NSCLC patients whose cancer has the KRAS G12C mutation

Clinical Trial Reference Number:

NCT04303780

Protocol number: 20190009
If you’re interested in the CodeBreaK 200 clinical trial, you can print this page and show it to your doctor or give this clinical trial reference number to your doctor.

Who can participate?

The study doctor will determine eligibility of each potential participant. If you fit the profile below, this trial might be an option for you.

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Lung Cancer

Patients diagnosed with non-small cell lung cancer (NSCLC) that has spread to areas near the lungs and can’t be removed by surgery or that has spread to other parts of the body

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KRAS G12C Mutation

Patients whose NSCLC contains the KRAS G12C mutation

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Age

Patients who are age 18 years and older

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Prior Treatment

Patients who have received prior treatment with chemotherapy and an anti-cancer drug known as a checkpoint inhibitor

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 find out about the KRAS G12C mutation. You or your doctor can also contact us for more information.

What are the study drugs?

All study participants will receive an active study drug—either sotorasib or a lung cancer treatment called docetaxel—during this clinical trial. The study drug you receive is based on your study group. Neither you nor the study doctor can choose your study group, but you and the doctor will know which study drug you receive.

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50% of participants will receive sotorasib

50% of participants will receive docetaxel

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Sotorasib (oral tablets)

  • Once a day
  • Study drug*
*Not approved for uses other than research

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Docetaxel (IV infusion)

  • Once every 3 weeks
  • Approved drug*
*Currently used as a standard treatment for NSCLC

What happens in this clinical trial?

If you agree to join the 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 one of two treatment groups. The treatment group you are assigned determines which study drug you receive.

CodeBreaK 200 is a Phase 3 clinical trial.

  • About 650 study participants


Timeline

Screening period

  • Up to 4 weeks
  • Attend a screening visit to provide medical history
  • Have medical testing done to see if you meet the requirements for participating in the clinical trial
Timeline

Treatment period

  • The length of time that you receive treatment will vary depending on how you respond to treatment
  • Attend study appointments
  • Take your assigned study drug
  • Record when you take your dose each day

Long-term follow up period

  • 5+ years
  • Talk to the study team by phone or visit the study clinic about every 3 months

Where are the 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 this clinical trial, finding a trial location near you, or how to enroll in the trial, contact an Amgen Medical Information Healthcare Professional.

Where can I get more information?

If you want more information about CodeBreaK 200 and whether this clinical trial is an option for you, please contact an Amgen Medical Information Healthcare Professional or talk to your doctor.

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