Targeted Treatment for Advanced Non-Squamous Non-Small Cell Lung Cancer That Has a KRASG12C Gene Change
What is the purpose of this clinical trial?
If cancer is KRASG12C-positive, it means testing has found a specific change (also known as a biomarker) in the cancer’s KRAS gene. This gene change can cause the cancer to grow and spread.
This study tests a drug called sotorasib, which fights cancer by targeting the KRASG12C gene change. Sotorasib has been approved by the Food and Drug Administration (FDA) for treating advanced non-small cell lung cancer. But doctors don’t know how well the drug works against KRASG12C-positive cancer that also has other gene changes. The study aims to learn if other gene changes affect how cancer responds to sotorasib.
This trial is set up to find out:
- If the drug sotorasib works to shrink or control non-small cell lung cancer that has other gene changes in addition to a KRASG12C gene change
- Which other gene changes may affect how cancer responds to sotorasib
- What side effects people may have from taking sotorasib
Why is this trial important?
This trial is a chance to help doctors learn how to treat KRASG12C-positive lung cancer that has other gene changes. Knowing if other gene changes affect treatment with sotorasib may improve how doctors use the drug to treat cancer. It could lead to better treatment options for patients in the future.
Who can be in this trial?
This trial is for adults, age 18 or older, with non-squamous non-small cell lung cancer that is stage 4 or has come back.
This trial may be for people who:
- Have KRASG12C-positive cancer (with or without other gene changes)
- Have cancer that has gotten worse after earlier treatment
This trial is not for people who:
- Have already received treatment that specifically targets a KRASG12C gene change
- Have serious heart problems
- Have an active HIV infection
- Are pregnant
Talk with your doctor to learn more about who can join this study.
What treatments will I get?
All people in this study will get treatment with the drug sotorasib.
How long will I be in the trial?
You will be in the study for 3 years. You will continue getting treatment for as long as you benefit from it. Your doctor may stop your treatment if side effects become too severe or if your condition gets worse. You may choose to stop treatment for any reason at any time.
If you stop getting treatment, you will have follow-up visits with the study team until 3 years after you started the study.
This trial is part of a larger study called Lung-MAP. If your condition gets worse, you may have the option to join another Lung-MAP study.
Are there costs? Will I get paid?
The drug sotorasib is provided free to you. You will not be paid for joining the study. Check with your health care provider and insurance provider to find out what costs will and won’t be covered in this study.
Where can I find more information about this trial?
- Talk with your health care provider
- Call the National Cancer Institute at 1-800-4-CANCER
- Go to ClinicalTrials.gov and search the national clinical trial number: 04625647