Study on Telisotuzumab Vedotin for Previously Treated c-Met+ Non-Small Cell Lung Cancer
Sponsor: AbbVie
ClinicalTrials ID:NCT03539536
This clinical trial is testing a new treatment, telisotuzumab vedotin, for patients with non-small cell lung cancer (NSCLC) that has a specific marker called c-Met+. The study aims to find out which patients benefit most from this treatment and to evaluate its safety and effectiveness.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to determine if telisotuzumab vedotin is effective for treating non-small cell lung cancer (NSCLC) that overexpresses a marker called c-Met. The study will first identify which patients are best suited for this treatment and then expand to further evaluate its effectiveness and safety in those patients. The study will be conducted in three stages, with the final stage testing a different dose level to ensure safety and effectiveness.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic non-small cell lung cancer (NSCLC).
- Have NSCLC with a c-Met+ marker, confirmed by a specific lab test. Patients need to provide a tumor sample for this test.
- Have a type of NSCLC that is not squamous and does not have a specific mutation in the EGFR gene. Patients with other mutations can participate if they meet all other criteria.
- Have received no more than two previous treatments for advanced cancer, including one chemotherapy treatment.
- Have tried and not responded to chemotherapy and an immune checkpoint inhibitor, or are not eligible for these treatments.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have had any brain metastases treated and stable before starting the study.
Exclusion Criteria
- Have had radiation therapy to the lungs within six months before starting the study.
- Have received a live vaccine within 30 days before starting the study.
- Have a type of lung cancer called adenosquamous.
- Have a history of other cancers, except those specified in the study.
- Have a history of lung diseases like interstitial lung disease or pneumonitis that required steroid treatment.
- Have signs of lung fibrosis or recent lung inflammation, unless deemed insignificant by a doctor.
- Have unresolved side effects from previous cancer treatments, except for hair loss or mild anemia.
- Have had major surgery within 21 days before starting the study.
- For participants in France and Czech Republic: Must not have active HIV, hepatitis B, or hepatitis C infections, or uncontrolled autoimmune diseases.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of South Alabama /ID# 212939 | 36604-3302 | Mobile | Alabama |
| Mayo Clinic Arizona /ID# 218550 | 85054-4504 | Phoenix | Arizona |
| Highlands Oncology Group, PA /ID# 215600 | 72762 | Springdale | Arkansas |
| University of California, Los Angeles /ID# 203219 | 90095 | Los Angeles | California |
| LA Hematology-Oncology Med Group /ID# 203338 | 92868 | Orange | California |
| Sutter Medical Center Sacramen /ID# 203299 | 95816 | Sacramento | California |
| Icri /Id# 227835 | 90603 | Whittier | California |
| Univ of Colorado Cancer Center /ID# 203212 | 80045 | Aurora | Colorado |
| Duplicate_Rocky Mountain Cancer Centers - Lone Tree /ID# 215789 | 80124 | Lone Tree | Colorado |
| Advanced Cancer Treatment Center /ID# 239565 | 34613-6072 | Brooksville | Florida |
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