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)
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|ClinicalTrials.gov Identifier: NCT05513703|
Recruitment Status : Recruiting
First Posted : August 24, 2022
Last Update Posted : January 18, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Biological: Telisotuzumab Vedotin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||November 21, 2022|
|Estimated Primary Completion Date :||November 15, 2025|
|Estimated Study Completion Date :||November 15, 2026|
Experimental: Telisotuzumab Vedotin
Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
Biological: Telisotuzumab Vedotin
Intravenous (IV) Infusion
Other Name: ABBV-399
- Objective response rate (ORR) as Assessed by an Independent Central Review (ICR) [ Time Frame: Up to 1 Year ]ORR will be 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 1 Year ]DoR will be defined for confirmed responders as the time from the initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1, or death from any cause.
- Disease Control Rate (DCR) [ Time Frame: Up to 1 Year ]DCR will be defined as the percentage of participants with best overall response of confirmed CR or confirmed PR, or stable disease (SD) for at least 12 weeks following first dose of study drug, based on RECIST, version 1.1.
- Progression Free Survival (PFS) per ICR [ Time Frame: Up to 1 Year ]PFS will be defined as the time from the participant's first dose of study drug to the first occurrence of radiographic progression based on RECIST, version 1.1 or death from any cause.
- Overall Survival (OS) [ Time Frame: Up to 2 Years ]OS will be defined as the time from participant's first dose of study drug to the event of death from any cause.
- Time to Deterioration in Cough [ Time Frame: Up to 1 Year ]Time to deterioration in cough as measured by the cough items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13).
- Time to Deterioration in Pain [ Time Frame: Up to 1 Year ]Time to deterioration in pain as measured by the cough items of the EORTC QLQ-LC13.
- Time to Deterioration in Dyspnea [ Time Frame: Up to 1 Year ]Time to deterioration in dyspnea as measured by the cough items of the EORTC QLQ-LC13.
- Time to Deterioration of Physical Functioning [ Time Frame: Up to 1 Year ]Time to deterioration of physical functioning as measured by the physical functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).
- Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). [ Time Frame: Up to 1 Year ]The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.
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): NCT05513703
|Contact: ABBVIE CALL CENTERemail@example.com|
|Study Director:||ABBVIE INC.||AbbVie|