M18-868 Open Label Teliso-V in NSCLC Patients (Phase 3)

• Research type

  Research Study

• Full 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

• IRAS ID

  1005087

• Contact name

  Aleksandra Jankielewicz

• Contact email

  global-clinical-trials@abbvie.com

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Eudract number

  2021-001811-94

• Clinicaltrials.gov Identifier

  NCT04928846

• Research 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. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel.
  Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 250 sites worldwide.
  Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  22/ES/0032

• Date of REC Opinion

  26 Sep 2022

• REC opinion

  Further Information Favourable Opinion