Clareo Health | A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Must have c-Met overexpressing non-small cell lung cancer (NSCLC) (defined as \>= 25% tumor cells with 3+ staining (high \[\>= 50% 3+\]; intermediate \[\>= 25% - \< 50%\]) as assessed by a Sponsor designated immunohistochemistry (IHC) laboratory
Must have histologically or cytologically documented NSCLC that is locally advanced or metastatic.
Must have a known epidermal growth factor receptor (EGFR) activating mutation status.
Actionable alterations in genes other than EGFR are permitted.
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 to 1.
Must have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting, as stated in the protocol.
Must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC, as stated in the protocol.
You may not be if
Adenosquamous or neuroendocrine histology, or sarcomatoid features.
Received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.
Received prior docetaxel therapy.
Metastases to the central nervous system (CNS). Participants with CNS metastases are eligible only after adequate treatment (such as surgery or, radiotherapy, or drug therapy) is provided, as stated on the protocol.
History of other malignancies except those stated in the protocol.
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, as noted in the protocol.
Unresolved clinically significant adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
Major surgery within 21 days prior to randomization.
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.
