Adding the Drug Selpercatinib to Usual Treatment for RET-positive, Advanced Non-Small Cell Lung Cancer
What is the purpose of this clinical trial?
If your cancer is RET-positive, it means testing has found certain changes in the cancer's RET gene. Finding these changes gives doctors more information about what is causing the cancer to grow and how to treat it. This study tests a drug called selpercatinib to treat RET-positive non-small cell lung cancer. The drug works by targeting abnormal RET proteins. Researchers hope to learn if adding the drug to the usual treatment can lower the chance of your cancer growing or spreading.
This trial is set up to find out:
- If adding the drug selpercatinib lowers the chance of the cancer getting worse
- How safe it is for patients to receive selpercatinib with usual treatment
- How patients respond to the usual treatment with and without selpercatinib
Why is this trial important?
This trial is part of a larger study called Lung-MAP. In Lung-MAP, researchers want to find better treatments for people with advanced non-small cell lung cancer. Only a small number of people with non-small cell lung cancer have RET-positive cancer. This trial is a way to learn if targeting the RET protein can improve treatment for these people.
Who can be in this trial?
This trial is for adults, age 18 or older, with stage 4 non-small cell lung cancer.
This trial may be for people who:
- Have RET-positive cancer
- Have cancer that has returned or gotten worse after treatment
This trial is not for people who:
- Have leptomeningeal disease (cancer that has spread to the central nervous system)
- Have spinal cord compression (a condition that puts pressure on nerves along the spine)
- Have another cancer that may make it unsafe to get treatment in this study
- Have serious heart problems
- Have an active hepatitis C or HIV infection
- Are pregnant
Talk with your doctor to learn more about who can join this trial.
What treatments will I get?
If you join this study, you will be assigned to one of 2 study groups.
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Group 1:
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Group 2:
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Your doctor will not have control over which group you will be assigned to. This helps make sure the study results are fair and reliable.
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 your condition gets worse.
If you stop getting treatment, you will have follow-up visits with the study team until 3 years after you started the study.
If your condition gets worse, you may have the option to join another Lung-MAP study.
Are there costs? Will I get paid?
The study drug, selpercatinib, 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: 05364645
- Go to lung-map.org/patients