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 (Jun 2026). This Phase 3 trial studies multiple treatments including Telisotuzumab Vedotin and Docetaxel for non small cell lung cancer.
Treatment: Telisotuzumab Vedotin · Docetaxel — 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 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Non-Small Cell Lung Carcinoma
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
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 →Frequently asked questions
Is NCT04928846 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior c-Met-targeted antibody, antibody-drug conjugate targeting c-Met or consisting of monomethylauristatin E, docetaxel disqualifies patients from enrollment.
Does this trial require MET?
Yes, MET overexpression is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR activating mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages