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. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 330 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. At the conclusion of the study, participants who continue to demonstrate clinical benefit may be eligible to receive study treatment via an extension of the study, a rollover study, or through another mechanism. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
698
Intravenous (IV) Infusion
IV Infusion
University of Alabama at Birmingham - Main /ID# 247074
Birmingham, Alabama, United States
ACTIVE_NOT_RECRUITINGIronwood Cancer & Res Ctr /ID# 262446
Chandler, Arizona, United States
ACTIVE_NOT_RECRUITINGMayo Clinic Arizona /ID# 255858
Phoenix, Arizona, United States
RECRUITINGOnvida Health Yuma Medical Center /ID# 253625
Yuma, Arizona, United States
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
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 BICR or death from any cause.
Time frame: Up to approximately 39 months
Overall Survival (OS)
OS is defined as the time from randomization to the event of death from any cause.
Time frame: Up to approximately 39 months
Objective Response Rate (ORR), per BICR.
ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) based on RECIST v1.1
Time frame: Up to approximately 58.25 months
Duration of Response (DoR), per BICR
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.
Time frame: Up to approximately 58.25 months
PFS per Investigator Assessment
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 per investigator or death from any cause. Participants with no PFS event will be censored at the last evaluable radiographic assessment per investigator. Participants with no event and no evaluable post-baseline assessment will be censored at randomization.
Time frame: Up to approximately 58.25 months
Change from Baseline of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).
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.
Time frame: Up to approximately 12 Weeks
Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30.
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.
Time frame: Up to approximately 12 Weeks
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City of Hope /ID# 243157
Duarte, California, United States
RECRUITINGCity Of Hope - Seacliff /ID# 263143
Huntington Beach, California, United States
RECRUITINGCity of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144
Irvine, California, United States
RECRUITINGCity Of Hope - Antelope Valley /ID# 263138
Lancaster, California, United States
RECRUITINGThe Oncology Institute Of Hope & Innovation -East Los A /ID# 239774
Los Angeles, California, United States
COMPLETEDUniversity of California, Los Angeles /ID# 253954
Los Angeles, California, United States
RECRUITING...and 306 more locations