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 assess how safe telisotuzumab vedotin is in adult participants with NSCLC. 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 telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 70 to 80 sites worldwide. Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration. 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
150
Intravenous (IV) Infusion
Ironwood Cancer & Research Center /ID# 276370
Chandler, Arizona, United States
RECRUITINGUniversity of Arkansas for Medical Sciences /ID# 272923
Little Rock, Arkansas, United States
RECRUITINGValkyrie Clinical Trials /ID# 271322
Los Angeles, California, United States
RECRUITINGYale New Haven Hospital /ID# 271584
New Haven, Connecticut, United States
Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2)
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Time frame: Up to Approximately 3 Years
Percentage of Participants with Treatment-Emergent Interstitial Lung Disease (ILD)
ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication (any-grade and Grade \>= 2).
Time frame: Up to Approximately 3 Years
Percentage of Participants with Treatment-Emergent Peripheral Neuropathy
Peripheral neuropathy is defined by peripheral neuropathy SMQ (narrow) (any-grade and Grade \>= 2)
Time frame: Up to Approximately 3 Years
Percentage of Participants with Treatment-Emergent Ocular Surface Disorders
Treatment-emergent ocular surface disorders defined by corneal epitheliopathy company MedDRA query (CMQ) (any-grade and Grade \>= 2).
Time frame: Up to Approximately 3 Years
Percentage of Participants with Treatment-Emergent AEs Leading to Study Drug Discontinuation
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Time frame: Up to Approximately 3 Years
Percentage of Participants with Grade 5 Treatment-Emergent AEs
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Time frame: Up to Approximately 3 Years
Objective Response (OR) by Blinded Independent Central Review (BICR)
OR will be defined as achieving 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
Concentrations of Telisotuzumab Vedotin Conjugate in Serum
Concentrations of telisotuzumab vedotin conjugate in serum.
Time frame: Up to 26 Weeks
Concentrations of Monomethylauristatin E (MMAE) Payload in Plasma
Concentrations of MMAE payload in plasma.
Time frame: Up to 26 Weeks
Percentage of Participants with Antidrug Antibodies (ADAs) of Telisotuzumab Vedotin
Percentage of participants with ADAs of telisotuzumab vedotin.
Time frame: Up to 26 Weeks
Percentage of Participants with Neutralizing Antidrug Antibodies (nADAs) of Telisotuzumab Vedotin
Percentage of participants with nADAs of telisotuzumab vedotin.
Time frame: Up to 26 Weeks
Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in patients participating in cancer clinical trials. PRO-CTCAE includes 124 items representing 78 symptomatic toxicities drawn from the Common Terminology Criteria for Adverse Events (CTCAE). PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. All questions employ a 7-day recall period and are scored from 0 to 4 (or 0/1 for absent/present).
Time frame: Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years
Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G)
The GP5 item ("I am bothered by side effects of treatment") of FACT-G is used to assess overall treatment tolerability in patients by assessing the overall side effect impact on participants.
Time frame: Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years
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Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
Jacksonville, Florida, United States
RECRUITINGOcala Oncology Center /ID# 273697
Ocala, Florida, United States
RECRUITINGComprehensive Hematology Oncology /ID# 270422
St. Petersburg, Florida, United States
RECRUITINGFlorida Cancer Specialists - North /ID# 271995
St. Petersburg, Florida, United States
RECRUITINGFlorida Cancer Specialists - East /ID# 271993
West Palm Beach, Florida, United States
RECRUITINGUniversity Cancer & Blood Center /ID# 270969
Athens, Georgia, United States
RECRUITING...and 53 more locations
Duration of Response (DoR) by BICR
DoR is defined for confirmed responders as the time from the participants' initial 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 3 Years
Progression-Free Survival (PFS) by BICR
PFS will be defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause.
Time frame: Up to Approximately 3 Years
Overall Survival (OS)
OS will be defined as the time from randomization to death from any cause.
Time frame: Up to Approximately 3 Years