OncoMatch/Clinical Trials/NCT06568939
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)
Is NCT06568939 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Telisotuzumab Vedotin for non-small cell lung cancer.
Treatment: Telisotuzumab Vedotin — Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 70 to 80 sites worldwide. Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: MET overexpression
Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory
Required: EGFR activating mutation
Must have a known epidermal growth factor receptor (EGFR) activating mutation status.
Excluded: EGFR activating mutation
Actionable EGFR activating mutations [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic cytotoxic chemotherapy — locally advanced or metastatic
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 received: any prior therapy for locally advanced/metastatic NSCLC — locally advanced or metastatic
Must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC, as stated in the protocol.
Cannot have received: c-Met-targeted antibody
Received prior c-Met-targeted antibodies
Cannot have received: antibody-drug conjugate targeting c-Met (telisotuzumab vedotin)
prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E
Cannot have received: antibody-drug conjugate consisting of monomethylauristatin E
prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E
Cannot have received: taxane (docetaxel)
Received prior docetaxel therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ironwood Cancer & Research Center /ID# 276370 · Chandler, Arizona
- University of Arkansas for Medical Sciences /ID# 272923 · Little Rock, Arkansas
- Valkyrie Clinical Trials /ID# 271322 · Los Angeles, California
- Yale New Haven Hospital /ID# 271584 · New Haven, Connecticut
- Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899 · Jacksonville, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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