Recruiting
Phase 3

Telisotuzumab Vedotin vs. Docetaxel

Sponsor:

AbbVie

Code:

NCT04928846

Conditions

Non Small Cell Lung Cancer

c-MET

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telisotuzumab Vedotin

Docetaxel

Study Details

Brief summary:

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 telisotuzumab vedotin or docetaxel at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 768 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.

Conditions

Non Small Cell Lung Cancer

c-MET

Study ID

NCT04928846

Start date

Mar 25, 2022

Status verified date

Oct, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Projected life expectancy of at least 12 weeks.
  • Participants must have 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.
  • Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.

  • If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
  • A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
  • A known epidermal growth factor receptor (EGFR) activating mutation status.

\-- Participants with EGFR activating mutations are not eligible
  • Actionable alterations in genes other than EGFR are eligible.
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
  • Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC

  • Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
  • Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase \[ALK\] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.

  • Participants with gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
  • Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
  • Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:

  • They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day \[QD\] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.

Exclusion Criteria:

  • Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment.
  • Evidence of leptomeningeal disease.
  • Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
  • Epidermal growth factor receptor (EGFR) activating mutations.
  • Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
  • Participants who have received prior docetaxel therapy.
  • A history of other malignancies except:

  • Malignancy treated with curative intent and with no known active disease present for >=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. Additionally, participants must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization..
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ without current evidence of disease.
  • A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, evidence of active pneumonitis on screening chest computed tomography (CT) scan or prior pneumonectomy. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.
  • Unresolved nor 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) as listed in the protocol.

Study Design

Enrollment

768 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telisotuzumab Vedotin

Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.

active comparator: Docetaxel

Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.

Interventions

Telisotuzumab Vedotin

Intravenous (IV) Infusion

Docetaxel

IV Infusion

Primary outcome measure

  • Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 39 months ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 39 months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

City of Hope /ID# 243157

Recruiting

Duarte, California, United States, 91010

City Of Hope - Seacliff /ID# 263143

Recruiting

Huntington Beach, California, United States, 92648

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144

Recruiting

Irvine, California, United States, 92618

City Of Hope - Antelope Valley /ID# 263138

Recruiting

Lancaster, California, United States, 93534

Kaiser Permanente Moanalua Medical Center /ID# 238363

Recruiting

Honolulu, Hawaii, United States, 96819-1469

Hattiesburg Clinic /ID# 248033

Recruiting

Hattiesburg, Mississippi, United States, 39401

St. Lukes Hosp. of Kansas City /ID# 259940

Recruiting

Kansas City, Missouri, United States, 64111

Hulston Cancer Center /ID# 232226

Recruiting

Springfield, Missouri, United States, 65807-5287

Valley Medical Center /ID# 253950

Recruiting

Renton, Washington, United States, 98055-5738

Cross Cancer Institute. /ID# 252065

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

William Osler Health System - Brampton Civic Hospital /ID# 254420

Recruiting

Brampton, Ontario, Canada, L6R 3J7

CISSS de la Monteregie /ID# 239081

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

CSSS Alphonse-Desjardins, CHAU de Levis /ID# 261158

Recruiting

Lévis, Quebec, Canada, G6V 3Z1

Hopital Du Sacre-Coeur De Montreal /ID# 274584

Recruiting

Montreal, Quebec, Canada, H4J 1C5

More Information

Sponsor

AbbVie

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Keywords

  • c-Met Overexpressing Non-Small Cell Lung Cancer
  • c-Met NSCLC
  • Telisotuzumab Vedotin
  • ABBV-399
  • Docetaxel
  • Cancer
  • Non Small Cell Lung Cancer
  • NSCLC
  • TeliMET NSCLC-01
  • Teliso-V
  • c-Met protein overexpression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.