Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03539536|
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : May 20, 2022
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Telisotuzumab vedotin||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||310 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 10, 2018|
|Estimated Primary Completion Date :||January 16, 2025|
|Estimated Study Completion Date :||January 16, 2025|
Experimental: Telisotuzumab vedotin
Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
Drug: Telisotuzumab vedotin
Intravenous (IV) infusion
Other Name: ABBV-399
- Overall Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]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.
- Duration of Response (DoR) [ Time Frame: Up to approximately 3 years ]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.
- Disease Control Rate (DCR) [ Time Frame: Up to approximately 3 years ]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.
- Progression-Free Survival (PFS) [ Time Frame: Up to approximately 3 years ]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.
- Overall Survival (OS) [ Time Frame: Up to approximately 3 years ]OS is defined as the time from the participant's first dose of study drug until death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539536
|Contact: ABBVIE CALL CENTERemail@example.com|
|Study Director:||ABBVIE INC.||AbbVie|