Home › Trials › NCT06568939

Assessing the safety of telisotuzumab vedotin in adults with non-small cell lung cancer

A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Phase 2 Interventional AbbVie · NCT06568939

This study is testing a new drug called telisotuzumab vedotin to see if it is safe for adults with non-small cell lung cancer that has already been treated.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionstelisotuzumab, chemotherapy
Locations64 sites (Chandler, Arizona and 63 other locations)
Trial IDNCT06568939 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and pharmacokinetics of telisotuzumab vedotin, an investigational drug, in adult patients with previously treated non-small cell lung cancer (NSCLC) that overexpresses c-Met. Participants will be randomly assigned to receive one of three different intravenous doses of the drug. The study aims to enroll approximately 150 participants across 70 to 80 sites worldwide, with a focus on monitoring adverse events and changes in disease activity over a three-year period.

Who should consider this trial

Good fit: Ideal candidates are adults with c-Met overexpressing non-small cell lung cancer who have progressed on at least one line of prior therapy.

Not a fit: Patients with adenosquamous or neuroendocrine histology may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise with similar targeted therapies in NSCLC, but the specific approach of telisotuzumab vedotin is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Projected life expectancy of at least 12 weeks.
* Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory
* Must have histologically or cytologically documented NSCLC that is locally advanced or metastatic.
* Must have a known epidermal growth factor receptor (EGFR) activating mutation status.
* Actionable alterations in genes other than EGFR are permitted.
* Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* 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 progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC, as stated in the protocol.

Exclusion Criteria:

* Adenosquamous or neuroendocrine histology, or sarcomatoid features.
* Actionable EGFR activating mutations.
* Received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.
* Received prior docetaxel therapy.
* Metastases to the central nervous system (CNS). Participants with CNS metastases are eligible only after adequate treatment (such as surgery or, radiotherapy, or drug therapy) is provided, as stated on the protocol.
* History of other malignancies except those stated in the protocol.
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan, as noted in the protocol.
* Unresolved clinically significant adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
* Major surgery within 21 days prior to randomization.
* Clinically significant condition(s) including but not limited to those listed in the protocol.
* Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis.
* Grade \>= 2 edema or lymphedema.
* Grade \>= 2 ascites or pleural effusion.
* Grade \>= 2 neuropathy.
* Active uncontrolled bacterial or viral infection.
* Active corneal disorder.

Where this trial is running

Chandler, Arizona and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small Cell Lung CancerNSCLCTelisotuzumab VedotinABBV-399TeliMET NSCLC-04
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.