Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer [M14-239]

AbbVie GK0 个研究点目标入组 35 人开始时间: 2018年9月21日最近更新: 2023年10月17日

试验速览

暂无简介。

•Histologically confirmed non-squamous cell non-small cell lung cancer (NSCLC) with known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site documented status). Of note, participants with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met.
•- Has locally advanced or metastatic NSCLC.
•- Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. Participant must submit archival or fresh tumor material for assessment of c-Met levels during the pre-screening period. If archival tissue is c-Met negative, participant can submit fresh biopsy material for reassessment of c-Met expression.
•- Have received no more than 2 lines of prior systemic therapy (including no more than 1 line of prior systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting.
•*Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same gene alteration count as 1 line of therapy for the purposes of this eligibility criterion
•- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

•- Have received prior c-Met-targeted antibody-based therapies.
•- Has adenosquamous histology.
•- Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy).
•- Has a clinically significant condition(s) described in the protocol.
•- Has unresolved clinically significant adverse events >= grade 2 from prior anticancer therapy, except for alopecia or anemia.
•- Had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
•- Has received live vaccine within 30 days of the first dose of telisotuzumab vedotin.
•- History of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis.
•- Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
•- Participants do not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or interstitial lung disease within 3 months of the planned first dose of the study drug.
•- Participants must not have received radiation therapy to the lung <6 months prior to the first dose of telisotuzumab vedotin.

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