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OncoMatch/Clinical Trials/NCT04928846

A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Is NCT04928846 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Telisotuzumab Vedotin and Docetaxel for non small cell lung cancer.

Phase 3RecruitingAbbVieNCT04928846Data as of May 2026

Treatment: Telisotuzumab Vedotin · DocetaxelCancer 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 determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. 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 Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 330 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. At the conclusion of the study, participants who continue to demonstrate clinical benefit may be eligible to receive study treatment via an extension of the study, a rollover study, or through another mechanism. 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.

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Extracted eligibility criteria

Cancer type

Small Cell Lung Cancer

Biomarker criteria

Required: MET overexpression

c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay

Excluded: EGFR activating mutation

Participants with actionable EGFR activating mutations are not eligible; Epidermal growth factor receptor (EGFR) activating mutations [excluded]

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: systemic cytotoxic chemotherapy — locally advanced or metastatic

Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC

Cannot have received: c-Met-targeted antibody

Participants who have received prior c-Met-targeted antibodies

Cannot have received: antibody-drug conjugate targeting c-Met or consisting of monomethylauristatin E (telisotuzumab vedotin)

prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E

Cannot have received: docetaxel (docetaxel)

Participants who have received prior docetaxel therapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Alabama at Birmingham - Main /ID# 247074 · Birmingham, Alabama
  • Ironwood Cancer & Res Ctr /ID# 262446 · Chandler, Arizona
  • Mayo Clinic Arizona /ID# 255858 · Phoenix, Arizona
  • Onvida Health Yuma Medical Center /ID# 253625 · Yuma, Arizona
  • City of Hope /ID# 243157 · Duarte, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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