Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Part of paid clinical trials in Mobile, Alabama.
- Sponsor
- AbbVie
- Study ID
- NCT03539536
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Telisotuzumab vedotin — DRUGIntravenous (IV) infusion
Study Details
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).
Key Dates
- Start date
- Oct 10, 2018
- Status verified
- Nov 2025
- Primary completion
- Jul 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 270 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Telisotuzumab vedotinTelisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
Primary Outcome Measure
Overall Response Rate (ORR) (Stage 1 and Stage 2) [ Time Frame: Up to approximately 3 years ]
Locations (56)
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