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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT06093503
Eligibility Criteria:
Inclusion Criteria:
* Must have metastatic/locally advanced non-squamous NSCLC with documented epidermal growth factor receptor (EGFR) mutation del19 or L858R, with or without T790M mutation, and no identified EGFR mutations known to confer resistance to osimertinib (for instance C797S).
* Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory.
* Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* Must have measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1.
* Must have received one prior regimen in the metastatic setting, consisting of a third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKi) (for instance, osimertinib). Participant must have had one disease progression while on this third generation EGFR TKi. Prior-rechallenge with a third generation EGFR TKi is not allowed. Treatment with a first or second generation EGFR TKi immediately prior to the third generation EGFR TKi will not count as one prior regimen. Those who have received a third generation EGFR TKi as adjuvant therapy, and have progressed within 6 months of the last dose of treatment will be eligible (i.e., considered as having received a third generation EGFR TKi in the metastatic setting).
* Must be considered appropriate for platinum therapy based on the assessment of the treating physician.
* Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and:
* There is no evidence of progression of CNS metastases at least 4 weeks after definitive therapy.
* Participant is asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 4 weeks prior to first dose of telisotuzumab vedotin.
* There is no leptomeningeal seeding of the disease.
* History of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
Exclusion Criteria:
* Have adenosquamous histology, nor sarcomatoid features.
* Alterations in ALK, ROS1, or BRAF that predict sensitivity to targeted therapies.
* Have small-cell histology.
* Have received prior chemotherapy in the metastatic setting. For the enrollment criterion, if a subject has received one to two cycles of platinum-based chemotherapy prior to starting a third generation EGFR TKi, without progression and while awaiting EGFR status results, it will not be counted as "prior platinum therapy." Those who have received platinum-based chemotherapy as adjuvant therapy, and have progressed within 6 months of the last dose will be counted as having received a prior platinum therapy in the metastatic setting.
* Have a history of other malignancies except those listed 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.
* 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) including but not limited to those listed in the protocol.
* Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis.
* Grade \>= 2 edema or lymphedema.
* Grade \>= 2 ascites or pleural effusion.
* Grade \>= 2 neuropathy.
* Active uncontrolled bacterial or viral infection.
* Active corneal disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06093503
Study Brief:
Protocol Section:
NCT06093503