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 (Sep 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 80 to 90 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
Treatments studied
Targeted therapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: MET overexpression (≥ 25% tumor cells with 3+ staining (high [≥ 50% 3+]; intermediate [≥ 25% - < 50%]))
Must have c-Met overexpressing non-small cell lung cancer (NSCLC) (defined as ≥ 25% tumor cells with 3+ staining (high [≥ 50% 3+]; intermediate [≥ 25% - < 50%]) as assessed by a Sponsor designated immunohistochemistry (IHC) laboratory
Required: EGFR wild-type
EGFR activating mutations (e.g., EGFR Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion mutations) [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy for locally advanced/metastatic NSCLC — locally advanced/metastatic NSCLC
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 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)
Received prior docetaxel therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Genesis Healthcare System /ID# 273361 · Zanesville, Ohio
- Guthrie Robert Packer Hospital /ID# 270316 · Sayre, Pennsylvania
- Cancer Care Associates Of York /ID# 270971 · York, Pennsylvania
- Medical University of South Carolina /ID# 273272 · Charleston, South Carolina
- Saint Francis Cancer Center - Greenville /ID# 276368 · Greenville, South Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06568939 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.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
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