Clinical Trial Summary (S1900G)
Combining Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes
What is the purpose of this clinical trial?
This study tests targeted treatments for people with advanced non-small cell lung cancer that has certain changes (mutations) in both the EGFR and MET genes. Finding these changes gives your doctor more information about what is causing the cancer to grow and how to treat it.
Targeted drugs fight specific changes in cancer cells that help tumors grow and spread. Treatment in this study targets EGFR and MET gene changes with 2 drugs, osimertinib and capmatinib.
Researchers want to find out if adding another drug called ramucirumab can improve treatment with osimertinib and capmatinib. Combining all 3 drugs might be better at fighting the cancer.
This trial is set up to find out:
- If adding the drug ramucirumab to osimertinib and capmatinib lowers the chance that the cancer will spread or get worse
- How safe the study treatments are for people with advanced non-small cell lung cancer
Why is this trial important?
Some people who start treatment for cancer with an EGFR gene change develop a MET gene change. MET gene changes can cause an EGFR targeted drug to stop working. Research on targeted drugs is quickly advancing, and this trial is a chance to improve treatment for cancer that has both gene changes.
There is evidence that combining EGFR and MET targeted drugs is safe and works to fight cancer. The Food and Drug Administration (FDA) has separately approved osimertinib and capmatinib to treat advanced non-small cell lung cancer.
There is also evidence that adding ramucirumab could improve treatments that use EGFR and MET targeted drugs. Ramucirumab has been approved by the FDA for use with other drugs for advanced non-small cell lung cancer.
Who can be in this trial?
This trial is for adults, age 18 or older, with non-small cell lung cancer that is stage 4 or has come back after treatment.
This trial may be for people who:
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Have cancer with EGFR and MET gene changes
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Have cancer that has gotten worse after treatment using the EGFR targeted drug, osimertinib
This trial is not for people who:
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Have another cancer that may make it unsafe to get treatment in this study
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Have serious heart problems
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Have an active HIV infection
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Are pregnant
Talk with your doctor to learn more about who can join this trial.
What treatments will I get?
Each drug in this study targets cancer cells in a different way:
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Osimertinib (Tagrisso) targets EGFR gene changes
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Capmatinib (Tabrecta) targets MET gene changes
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Ramucirumab (Cyramza) blocks tumors from forming new blood vessels (pathways that carry blood to the tumor)
If you join this study, you will be randomly assigned to one of 2 study groups.
|
Group 1: |
osimertinib + capmatinib + ramucirumab |
Group 2:  |
osimertinib + capmatinib |
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 may be in the study for up to 3 years. You will continue getting treatment for as long as you benefit from it. You may choose to stop being in the study for any reason at any time. 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 the end of 3 years.
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 study drugs capmatinib and ramucirumab are provided free in this study. The study does not cover the cost of the drug osimertinib.
Check with your health care provider and insurance provider about what costs will and won’t be covered in this study. You will not be paid for joining the 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 www.ClinicalTrials.gov and search the national clinical trial number: 05642572
- Go to lung-map.org/patients
Key Information
Information your doctor or trial navigator may need to help you.
Protocol Number
S1900G
NCT Number
05642572
Full Trial Title
A Randomized Phase II Study of INC280 Capmatinib plus Osimertinib with or without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung- MAP Sub-Study)
Trial Sponsors
SWOG Cancer Research Network
Publication Date