Study Comparing TAK-788 and Chemotherapy for Non-Small Cell Lung Cancer with EGFR Exon 20 Mutations
Sponsor: Takeda
ClinicalTrials ID:NCT04129502
This clinical trial is testing a new drug, TAK-788, against standard chemotherapy to see which is more effective as a first treatment for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation.
Patient Parameters
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Program Overview
The study aims to compare the effectiveness of a new drug, TAK-788, with traditional platinum-based chemotherapy in treating patients with advanced non-small cell lung cancer (NSCLC) that has a specific mutation in the EGFR gene known as exon 20 insertion. Participants will be randomly assigned to receive either TAK-788 or chemotherapy. The treatment will continue until the cancer worsens, side effects become too severe, or other criteria for stopping are met.
Description
This study is testing a new drug called TAK-788 to see if it works better than standard chemotherapy for treating advanced non-small cell lung cancer (NSCLC) with a specific genetic mutation called EGFR exon 20 insertion. About 318 patients will participate, and they will be randomly assigned to one of two groups: one group will take TAK-788 orally, and the other will receive chemotherapy drugs (pemetrexed with either cisplatin or carboplatin) through an IV. If the cancer progresses, patients in the chemotherapy group may switch to TAK-788. The study will take place in the US, Europe, and Asia, and will last until three years after the last participant starts treatment. Participants will have regular clinic visits and follow-ups to monitor their health and the treatment's effectiveness.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Diagnosed with advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or has spread.
- Have a specific genetic mutation in the EGFR gene called exon 20 insertion.
- Have enough tumor tissue available for testing.
- Have at least one tumor that can be measured.
- Expected to live at least 3 more months.
- In good general health, able to carry out normal activities or light work.
- Have good organ and blood function as shown by recent tests.
Exclusion Criteria
- Have received previous treatment for advanced or metastatic cancer, except for certain early-stage treatments completed over 6 months ago.
- Have had radiation therapy within 14 days before starting the study or have not recovered from its side effects.
- Have taken certain medications that affect how TAK-788 works within 10 days before starting the study.
- Have another type of cancer besides NSCLC.
- Have spinal cord compression or cancer in the brain lining.
- Have uncontrolled high blood pressure.
- Have received a live vaccine within 4 weeks before starting the study.
- Are taking medications that can cause heart rhythm problems.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center | 90813 | Long Beach | California |
| University of California Irvine | 92868 | Orange | California |
| Stanford University | 94304 | Palo Alto | California |
| AdventHealth | 32804 | Orlando | Florida |
| Northwestern University | 60611 | Chicago | Illinois |
| University of Maryland Greenebaum Cancer Center | 21201 | Baltimore | Maryland |
| Beth Israel Deaconess Medical Center - 330 Brookline Ave | 02115 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02115 | Boston | Massachusetts |
| Massachusetts General Hospital | 02115 | Boston | Massachusetts |
| Sarah Cannon Cancer Center | 37203 | Nashville | Tennessee |
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