Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.

Telisotuzumab vedotin

ABBVIE INC.

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).

Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

DoR is defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression determined by an independent central review or death from any cause for the responders.

DCR is defined as the percentage of participants with best overall response of confirmed CR, confirmed PR, or stable disease (SD) for at least 12 weeks following enrollment, based on RECIST, version 1.1.

PFS is defined as the time from the participant's first dose of study drug until the first occurrence of radiographic progression determined by an independent central review or death from any cause.

OS is defined as the time from the participant's first dose of study drug until death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer	NCT03539536	Non-small Cell ...	Telisotuzumab v...	18 Years -	AbbVie
Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer	NCT03539536	Non-small Cell ...	Telisotuzumab v...	18 Years -	AbbVie

Spots Global Cancer Trial Database for met gene amplification