A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT04928846|
Recruitment Status : Not yet recruiting
First Posted : June 16, 2021
Last Update Posted : June 16, 2021
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 if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 600 adult participants with c-Met+ NSCLC will be enrolled in the study in approximately 250 sites worldwide.
Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 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 Drug: Docetaxel||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met+, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer|
|Estimated Study Start Date :||December 10, 2021|
|Estimated Primary Completion Date :||March 9, 2027|
|Estimated Study Completion Date :||March 9, 2027|
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
Active Comparator: Docetaxel
Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.
- Progression-Free Survival (PFS) [ Time Frame: Up to approximately 39 months ]PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per Independent Central Review (ICR) or death from any cause.
- Overall Survival (OS) [ Time Frame: Up to approximately 58.25 months ]OS is defined as the time from randomization to the event of death from any cause.
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 58.25 months ]ORR is defined as the percentage of subjects with a complete response (CR) or partial response (PR) based on RECIST v1.1, per ICR.
- Duration of Response (DoR) [ Time Frame: Up to approximately 58.25 months ]DoR is defined for responders as the time from response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause per ICR.
- Time to Deterioration in Cough, Pain or Dyspnea as measured by the Cough, Pain and Dyspnea items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) [ Time Frame: Up to approximately 58.25 months ]The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30. The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts.
- Time to Deterioration of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30). [ Time Frame: Up to approximately 58.25 months ]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.
- Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30. [ Time Frame: Up to approximately 58.25 months ]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): NCT04928846
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|United States, Michigan|
|Ascension Providence Hospital /ID# 231970|
|Southfield, Michigan, United States, 48075-4825|
|FNsP F.D.Roosevelta Banska Bystrica /ID# 230084|
|Banska Bystrica, Banskobystricky Kraj, Slovakia, 975 17|
|Fakultna nemocnica s poliklinikou Nove Zamky /ID# 230086|
|Nove Zamky, Nitriansky Kraj, Slovakia, 940 34|
|Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 232216|
|Bratislava, Slovakia, 821 01|
|Study Director:||ABBVIE INC.||AbbVie|