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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (6 UK sites)
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 254342
London E1 2ES, United Kingdom
UCLH NHS FT - University College Hospital /ID# 249407
London NW1 2BU, United Kingdom
Nottingham City Hospital /ID# 254707
Nottingham NG5 1PB, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 258141
Birmingham B15 2TH, United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 246974
London SW3 6JJ, United Kingdom
The Christie Hospital /ID# 243422
Manchester M20 4BX, United Kingdom
How to Get in Touch
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