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

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 Vedotin
    Participants 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)

FacilityCityStateZIPSite coordinators
Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671Los AlamitosCalifornia90720-3309-
Valley Medical Center /ID# 251880RentonWashington98055-5738-

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