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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505749-14-00

Acronym

M18-868

Enrollment

222

Registered

2023-11-28

Start date

2022-03-20

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

c-Met overexpressing EGFR wildtype non-squamous non-small cell lung cancer

Brief summary

The co-primary endpoints are: Progression-Free Survival (PFS) per blinded independent central review (BICR); Overall Survival (OS)

Detailed description

Objective Response Rate (ORR) by BICR, Duration of Response (DoR) by BICR, Change from baseline to Week 12 in physical functioning as measured by the physical functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30)., Change from baseline to Week 12 in quality of life as measured by the global health status/quality of life domain of the EORTC QLQ-C30., PFS per investigator assessment

Interventions

DRUGDOCETAXEL

DRUGTelisotuzumab Vedotin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The co-primary endpoints are: Progression-Free Survival (PFS) per blinded independent central review (BICR); Overall Survival (OS)	—

Secondary

Measure	Time frame
Objective Response Rate (ORR) by BICR, Duration of Response (DoR) by BICR, Change from baseline to Week 12 in physical functioning as measured by the physical functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30)., Change from baseline to Week 12 in quality of life as measured by the global health status/quality of life domain of the EORTC QLQ-C30., PFS per investigator assessment	—

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026