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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Intravenous (IV) infusion
Overall Response Rate (ORR) (Stage 1 and Stage 2)
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.
Time frame: Up to approximately 3 years
Number of Participants with Adverse Events (Alternate dose cohort)
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.
Time frame: Up to approximately 3 years
Duration of Response (DoR) (Stage 1 and Stage 2)
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.
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) (Stage 1 and Stage 2)
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.
Time frame: Up to approximately 3 years
Progression-Free Survival (PFS) (Stage 1 and Stage 2)
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.
Time frame: Up to approximately 3 years
Overall Survival (OS) (Stage 1 and Stage 2)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of South Alabama /ID# 212939
Mobile, Alabama, United States
Mayo Clinic Arizona /ID# 218550
Phoenix, Arizona, United States
Highlands Oncology Group, PA /ID# 215600
Springdale, Arkansas, United States
University of California, Los Angeles /ID# 203219
Los Angeles, California, United States
LA Hematology-Oncology Med Group /ID# 203338
Orange, California, United States
Sutter Medical Center Sacramen /ID# 203299
Sacramento, California, United States
Icri /Id# 227835
Whittier, California, United States
Univ of Colorado Cancer Center /ID# 203212
Aurora, Colorado, United States
Duplicate_Rocky Mountain Cancer Centers - Lone Tree /ID# 215789
Lone Tree, Colorado, United States
Advanced Cancer Treatment Center /ID# 239565
Brooksville, Florida, United States
...and 242 more locations
OS is defined as the time from the participant's first dose of study drug until death from any cause.
Time frame: Up to approximately 3 years