drugset / Trial / NCT03539536
Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2018-10-10
- Primary completion
- 2026-07
- Completion
- 2026-08
Publications
- Girard N, Goldman J, Lu S, Bar J, Horinouchi H, Daaboul N, Liu C, Cicin I, Katgi N, Zer A, Ciuleanu T, Reinmuth N, Planchard D, Lee SH, Mansfield AS, Moskovitz M, Baijal S, Baik C, Hrom JS, Heist RS, Yazici O, Verma M, Uema D, Patel S, Xia S, Ratajczak C, Camidge DR. Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein Overexpressing, Nonsquamous, EGFR Wild-type Advanced NSCLC: Updated Analysis of the LUMINOSITY Trial. JTO Clin Res Rep. 2026 Mar 16;7(7):100988. doi: 10.1016/j.jtocrr.2026.100988. eCollection 2026 Jul.
- Camidge DR, Bar J, Horinouchi H, Goldman J, Moiseenko F, Filippova E, Cicin I, Ciuleanu T, Daaboul N, Liu C, Bradbury P, Moskovitz M, Katgi N, Tomasini P, Zer A, Girard N, Cuppens K, Han JY, Wu SY, Baijal S, Mansfield AS, Kuo CH, Nishino K, Lee SH, Planchard D, Baik C, Li M, Ansell P, Xia S, Bolotin E, Looman J, Ratajczak C, Lu S. Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein-Overexpressing Advanced Nonsquamous EGFR-Wildtype Non-Small Cell Lung Cancer in the Phase II LUMINOSITY Trial. J Clin Oncol. 2024 Sep 1;42(25):3000-3011. doi: 10.1200/JCO.24.00720. Epub 2024 Jun 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telisotuzumab Vedotin | Monoclonal antibody | 1.9 mg/kg | Intravenous |