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Looking for participantsPhase3

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)

Sponsor: AbbVie

NCT ID: NCT04928846

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Telisotuzumab Vedotin (biological), Docetaxel (drug)
How long the study runs
Study runs about 83 months (dates as stated)
About the drug or intervention
Telisotuzumab Vedotin — biological: Intravenous (IV) Infusion · Docetaxel — drug: IV Infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
768
Started
2022-03-25
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for non small cell lung cancer
  • • Phase3 - 768 participants
  • • Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non small cell lung cancer

Where?

  • • London - Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 254342
  • • London - UCLH NHS FT - University College Hospital /ID# 249407
  • • Nottingham - Nottingham City Hospital /ID# 254707
  • • Birmingham - University Hospitals Birmingham NHS Foundation Trust /ID# 258141
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Non Small Cell Lung Cancerc-MET

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

MetMet overexpressingEGFRALK

What the study is looking for

  • ✓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...
  • ✓A histologically or cytologically documented non-squamous cell NSCLC that is that has grown locally or that has spread.
  • ✓A known epidermal growth factor receptor (EGFR) activating mutation status.
  • ✓\-- Participants with EGFR activating mutations are not eligible

Who cannot take part

  • ✗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...
See the full 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 Is This Study? (6 UK sites)

Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 254342

London E1 2ES, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

UCLH NHS FT - University College Hospital /ID# 249407

London NW1 2BU, United Kingdom

Recruiting

Nottingham City Hospital /ID# 254707

Nottingham NG5 1PB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

University Hospitals Birmingham NHS Foundation Trust /ID# 258141

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

The Royal Marsden NHS Foundation Trust /ID# 246974

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

The Christie Hospital /ID# 243422

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

ABBVIE CALL CENTER

Sponsor contact

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10