Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
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
Sponsor: AbbVie
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Overall Response Rate (ORR) (Stage 1 and Stage 2)
Time frame: Up to approximately 3 years
Number of Participants with Adverse Events (Alternate dose cohort)
Time frame: Up to approximately 3 years
Secondary Endpoints
Duration of Response (DoR) (Stage 1 and Stage 2)
Disease Control Rate (DCR) (Stage 1 and Stage 2)
Progression-Free Survival (PFS) (Stage 1 and Stage 2)
Eligibility Criteria
Inclusion Criteria: * Have locally advanced or metastatic non-small cell lung cancer (NSCLC). * Have 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 prescreening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, subject can submit fresh biopsy material for reassessment of c-Met expression. * Histologically documented non-squamous epidermal growth factor receptor (EGFR) wild type NSCLC (site documented EGFR status). Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met. As of Protocol Version 11, Stage 1 is complete and Stage 2 is enrolling participants with non-squamous EGFR wild type NSCLC only. * Must have received no more than 2 lines of prior systemic therapy (includin…
Read full criteria on CT.gov →✦ Analyst Commentary
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