M25-713: EGFR-mut NSCLC Ph2/3 Study of Temab-A Vs SoC After Progression on 3rd-Gen EGFR TKI

• Research type

  Research Study

• Full title

  A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects with Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713

• IRAS ID

  1012756

• Contact name

  Bernhard Dodell

• Contact email

  global-clinical-trials@abbvie.com

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Eudract number

  2025-521124-29

• Clinicaltrials.gov Identifier

  NCT07155187

• Research summary

  Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan compared to standard of care (SOC).
  Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan. In the second stage (phase 3) participants will
  receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 430 adult participants with NSCLC will be enrolled in the study in 200 sites around the world.
  In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  26/EM/0028

• Date of REC Opinion

  27 Mar 2026

• REC opinion

  Further Information Favourable Opinion