OncRef

Clinical Trial: NCT03539536

Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:AbbVie
Information Provided By:AbbVie
Last Update Posted:2025-11-05

Study Overview

Brief Summary

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).

Official Title

Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer

Conditions

Non-small Cell Lung Cancer

Intervention / Treatment

  • Drug: Telisotuzumab vedotin

Other Study ID Numbers

  • M14-239
  • 2023-507902-15-00
  • 2023

Start Date (Actual)

2018-10-10

Primary Completion Date (Estimated)

2026-07

Study Completion Date (Estimated)

2026-08

Enrollment (Actual)

270

Study Type

Interventional

Phase

Phase 2