A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants with Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Korábbi kezelés

• Subject must not have clinically significant condition(s) including but not limited to the following: 1) Clinically significant vascular disease, including: Myocardial infarction within 1 year or stroke within 6 months prior to first dose of study drug, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III – IV), cardiac arrhythmia (CTCAE Version 5 Grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities. 2) Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis. 3) Grade ≥ 2 edema or lymphedema. 4) Grade ≥ 2 ascites or pleural effusion. 5) Grade ≥ 2 neuropathy. 6) Active uncontrolled bacterial or viral infection.
• Subject must have no prior systemic therapy for locally advanced/metastatic NSCLC. 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. Subject 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.
• Subject must not have received prior c-Met-targeted antibodies.
• Subject must not have NSCLC that is eligible for treatment with curative intent.
• Subject must not have unresolved adverse events (AEs) ≥ Grade 2 from prior anticancer therapy, except for alopecia or anemia.
• Subject must not have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.

Más betegség

• Subject must not 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.

Laborértékek

• Subjects with alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy are not eligible. Subjects with other alterations that are candidates for available targeted therapy are not eligible.

Életkor

• Subjects must not have a history of other malignancies except: 1) Malignancy treated with curative intent and with no known active disease present for ≥ 2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. 2) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3) Adequately treated carcinoma in situ without current evidence of disease.

• Subjects must have completed an informed consent.
• Subject must be an adult, at least 18 years old.
• Subject 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. Where confirmed as a local requirement, the central assay can only be utilized after IVDR certification is obtained.
• Subject must have histologically documented non-squamous adenocarcinoma NSCLC that is locally advanced or metastatic.
• Subject must have measurable disease per RECIST version 1.1.
• Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Subjects with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and: 1) There is no evidence of progression of CNS metastases at least 2 weeks after definitive therapy. 2) They are asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 2 weeks prior to first dose of telisotuzumab vedotin.
• History of radiation pneumonitis in the radiation field (fibrosis) is permitted.