Study on the Safety and Effectiveness of Telisotuzumab Adizutecan with Osimertinib for Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Sponsor: AbbVie
ClinicalTrials ID:NCT07005102
This clinical trial is testing a new combination of drugs, telisotuzumab adizutecan and osimertinib, to see if they are safe and effective as a first treatment for adults with advanced non-small cell lung cancer that cannot be removed by surgery.
Patient Parameters
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Program Overview
Non-small cell lung cancer (NSCLC) is a type of lung cancer where cells in the lungs grow uncontrollably. This study aims to find out if a new drug, telisotuzumab adizutecan, when combined with osimertinib, can safely and effectively treat NSCLC with specific genetic changes. The study will compare this combination to osimertinib alone and standard treatments. Participants will receive different doses of the new drug to find the best one, and then be divided into groups to test the effectiveness of the treatment. The study will involve about 694 adults worldwide and will last around 76 months. Participants will have regular check-ups, tests, and questionnaires to monitor their health and the treatment's effects.
Eligibility Criteria
Inclusion Criteria
- Be in good general health with an activity level that allows for light work or better.
- Agree to provide a recent tumor sample for testing.
- Have at least one tumor that can be measured and has not been treated with radiation.
- Any side effects from previous cancer treatments must have improved to a mild level.
- Have a life expectancy of at least 3 months.
Exclusion Criteria
- Have a history of lung diseases like interstitial lung disease or pneumonitis that needed steroid treatment.
- Have certain lung conditions like idiopathic pulmonary fibrosis or drug-induced pneumonitis.
- Have cancer that has spread to the brain or spinal cord and is not treated.
- Have had another cancer unless it was treated successfully and has not returned for at least 2 years, or if it was a non-threatening type like certain skin cancers.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| USC Norris Comprehensive Cancer Center /ID# 275343 | 90033 | Los Angeles | California |
| Usc Norris Oncology/Hematology Treatment Center /ID# 278673 | 92663 | Newport Beach | California |
| Mid Florida Hematology And Oncology Center /ID# 275278 | 32763 | Orange City | Florida |
| The Iowa Clinic /ID# 276020 | 50266 | West Des Moines | Iowa |
| Nho - Revive Research Institute /ID# 276115 | 68506 | Lincoln | Nebraska |
| Renown Regional Medical Center /ID# 276049 | 89502 | Reno | Nevada |
| Texas Oncology - South Austin /ID# 276033 | 78745 | Austin | Texas |
| The University of Texas MD Anderson Cancer Center /ID# 275107 | 77030 | Houston | Texas |
| Texas Oncology - Palestine Cancer Center /ID# 276034 | 75801 | Palestine | Texas |
| Virginia Cancer Specialists - Fairfax /ID# 275071 | 22031 | Fairfax | Virginia |
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