Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT05513703
Eligibility Criteria:
Inclusion Criteria:
* Must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory MET FISH Assay or in plasma and/or tissue by a Sponsor-approved assay.
* Must have histologically documented non-squamous adenocarcinoma non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.
* Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Participant may have received prior adjuvant/neoadjuvant systemic chemotherapy and/or radiation and/or immunotherapy provided that the subject has not progressed on or within 6 months of completing the regimen and it was completed \>= 6 months before subject's first dose of study drug.
* Metastases to the central nervous system (CNS) are eligible only after definitive therapy is provided as noted in the protocol.
* History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Exclusion Criteria:
* Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy. Participants with other alterations that are candidates for available targeted therapy.
* Prior systemic therapy for locally advanced/metastatic NSCLC. Of note, limited treatment with no more than 1 cycle of chemotherapy is allowed prior to receiving the first dose of study drug provided there is no evidence of progression.
* Have a history of other malignancies except those noted in the protocol.
* Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
* Received prior c-Met-targeted antibodies.
* Have NSCLC that is eligible for treatment with curative intent.
* Have unresolved adverse events (AEs) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
* Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
* Have clinically significant condition(s) as noted in the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05513703
Study Brief:
Protocol Section:
NCT05513703