Clinical trial Recruiting at 263 sites Phase 3 Interventional Ages 18 and up

Comparing Telisotuzumab Vedotin and Docetaxel for Non-Small Cell Lung Cancer

Official title: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Run by AbbVie · NCT04928846 · Data updated 2026-11-12

This study is testing whether a new drug called telisotuzumab vedotin is better than the standard treatment docetaxel for adults with a specific type of lung cancer that has already been treated.

More Non-Small Cell Lung Cancer trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment768 (estimated)
SponsorAbbVie
Industry-sponsored
Drugs / interventionstelisotuzumab, chemotherapy, radiation, prednisone
Locations317 sites (Birmingham, Alabama and 316 other locations)
StatusRecruiting
StartedMarch 25, 2022
Main results expectedDecember 2028
Study endsFebruary 2029
Registry record updatedOctober 29, 2026
Trial IDNCT04928846 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with previously treated non-squamous NSCLC who have c-Met overexpression.

Probably not a fit

Patients with squamous cell lung cancer or those without c-Met overexpression may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of telisotuzumab vedotin compared to docetaxel in adults with previously treated non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met. Participants will be randomly assigned to receive either intravenous telisotuzumab vedotin every two weeks or intravenous docetaxel every three weeks. The study aims to assess changes in disease activity and monitor adverse events associated with each treatment. Approximately 698 participants will be enrolled across 300 sites worldwide.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with c-Met overexpressing NSCLC.

How similar studies have gone: Other studies have shown promising results with targeted therapies in NSCLC, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • City of Hope /ID# 243157
    Duarte, California, United States
    Recruiting
  • City Of Hope - Seacliff /ID# 263143
    Huntington Beach, California, United States
    Recruiting
  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144
    Irvine, California, United States
    Recruiting
  • City Of Hope - Antelope Valley /ID# 263138
    Lancaster, California, United States
    Recruiting
  • Kaiser Permanente Moanalua Medical Center /ID# 238363
    Honolulu, Hawaii, United States
    Recruiting
  • Hattiesburg Clinic /ID# 248033
    Hattiesburg, Mississippi, United States
    Recruiting
Show 44 more locations
  • St. Lukes Hosp. of Kansas City /ID# 259940
    Kansas City, Missouri, United States
    Recruiting
  • Hulston Cancer Center /ID# 232226
    Springfield, Missouri, United States
    Recruiting
  • Valley Medical Center /ID# 253950
    Renton, Washington, United States
    Recruiting
  • Cemic /Id# 231486
    Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
    Recruiting
  • Hospital Britanico de Buenos Aires /ID# 231495
    Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
    Recruiting
  • Centro Médico Austral /ID# 239860
    Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina
    Recruiting
  • Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339
    Viedma, Río Negro Province, Argentina
    Recruiting
  • LC Investigacion /ID# 239880
    Buenos Aires, Argentina
    Recruiting
  • Instituto de Oncologia Angel H Roffo /ID# 231499
    Buenos Aires, Argentina
    Recruiting
  • Port Macquarie Base Hospital /ID# 273654
    Port Macquarie, New South Wales, Australia
    Recruiting
  • Westmead Hospital /ID# 274447
    Westmead, New South Wales, Australia
    Recruiting
  • Barwon Health /ID# 241920
    Geelong, Victoria, Australia
    Recruiting
  • Austin Health /ID# 247507
    Heidelberg, Victoria, Australia
    Recruiting
  • Medizinische Universitaet Wien /ID# 230615
    Vienna, State of Vienna, Austria
    Recruiting
  • Klinik Penzing /ID# 230700
    Vienna, State of Vienna, Austria
    Recruiting
  • Klinik Floridsdorf /ID# 230608
    Vienna, State of Vienna, Austria
    Recruiting
  • Medizinische Universitaet Innsbruck /ID# 240981
    Innsbruck, Tyrol, Austria
    Recruiting
  • Ordensklinikum Linz Elisabethinen /ID# 240967
    Linz, Upper Austria, Austria
    Recruiting
  • Klinikum Wels-Grieskirchen Gmbh /ID# 249000
    Wels, Upper Austria, Austria
    Recruiting
  • Landeskrankenhaus Feldkirch /ID# 250333
    Feldkirch, Vorarlberg, Austria
    Recruiting
  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467
    Salzburg, Austria
    Recruiting
  • Algemeen Ziekenhuis klina /ID# 239853
    Brasschaat, Antwerpen, Belgium
    Recruiting
  • Universitair Ziekenhuis Antwerpen /ID# 239971
    Edegem, Antwerpen, Belgium
    Recruiting
  • Grand Hopital de Charleroi - Les Viviers /ID# 234178
    Charleroi, Hainaut, Belgium
    Recruiting
  • Hospital La Louviere Site Jolimont - Helora /ID# 246771
    La Louvière, Hainaut, Belgium
    Recruiting
  • Jessa Ziekenhuis /ID# 246766
    Hasselt, Limburg, Belgium
    Recruiting
  • UZ Gent /ID# 273244
    Ghent, Oost-Vlaanderen, Belgium
    Recruiting
  • Vitaz /Id# 246773
    Sint-Niklaas, Oost-Vlaanderen, Belgium
    Recruiting
  • Institut Jules Bordet /ID# 246770
    Anderlecht, Belgium
    Recruiting
  • AZ Maria Middelares /ID# 246768
    Ghent, Belgium
    Recruiting
  • CHU de Liege /ID# 246772
    Liège, Belgium
    Recruiting
  • UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 246769
    Namur, Belgium
    Recruiting
  • Clinica Amo - Rio Vermelho /ID# 231604
    Salvador, Estado de Bahia, Brazil
    Recruiting
  • Hospital Da Crianca Santo Antonio /ID# 233249
    Porto Alegre, Rio Grande do Sul, Brazil
    Recruiting
  • Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247
    Barretos, São Paulo, Brazil
    Recruiting
  • OC Oncoclínicas SP /ID# 261828
    São Paulo, São Paulo, Brazil
    Recruiting
  • Instituto Nacional de Cancer (INCA) /ID# 231509
    Rio de Janeiro, Brazil
    Recruiting
  • Instituto Dor de Pesquisa e Ensino /ID# 233245
    Rio de Janeiro, Brazil
    Recruiting
  • Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417
    São Paulo, Brazil
    Recruiting
  • Hospital Sirio Libanes - Sao Paulo /ID# 261827
    São Paulo, Brazil
    Recruiting
  • Casa de Saúde Santa Marcelina /ID# 231605
    São Paulo, Brazil
    Recruiting
  • Uni Hospital /ID# 273707
    Panagyurishte, Pazardzhik, Bulgaria
    Recruiting
  • University Multiprofile Hospital for Active Treatment Sofiamed /ID# 234108
    Sofiya, Sofia, Bulgaria
    Recruiting
  • Complex Cancer Center Plovdiv /ID# 234106
    Plovdiv, Bulgaria
    Recruiting

+267 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.