A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Part of paid clinical trials in Los Alamitos, California.
- Sponsor
- AbbVie
- Study ID
- NCT05513703
- Phase
- PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Telisotuzumab Vedotin — BIOLOGICALIntravenous (IV) Infusion
Study Details
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Key Dates
- Start date
- Nov 21, 2022
- Status verified
- Oct 2025
- Primary completion
- Oct 28, 2024
- Completion
- Oct 28, 2024
Study Design
- Enrollment
- 9 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Telisotuzumab VedotinParticipants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
Primary Outcome Measure
Objective Response Rate (ORR) as Assessed by an Independent Central Review (ICR) [ Time Frame: Up to approximately 1.5 years ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671 | Los Alamitos | California | 90720-3309 | - |
| Valley Medical Center /ID# 251880 | Renton | Washington | 98055-5738 | - |
Related coverage on Hipa.ai
- Telisotuzumab Vedotin Shows 33.3% ORR in NSCLC Trial ResultsTelisotuzumab Vedotin · Oct 24, 2025 · ClinicalTrials.gov
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