A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
NCT Number: NCT06568939
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-Small Cell Lung Cancer
Interventions: DRUG: Telisotuzumab Vedotin
Sponsor: AbbVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-30
Completion Date: 2028-02-09

Summary:
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 Teliso-V in 1 of 2 arms at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin. Approximately 100 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 40 sites worldwide.

Participants will receive IV telisotuzumab vedotin at 1 of 2 doses 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.

Primary Outcome Measures: 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., 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)., 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), 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)., 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., 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., 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., Up to Approximately 3 Years
Secondary Outcome Measures: Concentrations of Telisotuzumab Vedotin Conjugate in Serum, Concentrations of telisotuzumab vedotin conjugate in serum., Up to 26 Weeks|Concentrations of Monomethylauristatin E (MMAE) Payload in Plasma, Concentrations of MMAE payload in plasma., Up to 26 Weeks|Percentage of Participants with Antidrug Antibodies (ADAs) of Telisotuzumab Vedotin, Percentage of participants with ADAs of telisotuzumab vedotin., Up to 26 Weeks|Percentage of Participants with Neutralizing Antidrug Antibodies (nADAs) of Telisotuzumab Vedotin, Percentage of participants with nADAs of telisotuzumab vedotin., 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)., 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., Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years|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., 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., Up to Approximately 3 Years|Overall Survival (OS), OS will be defined as the time from randomization to death from any cause., Up to Approximately 3 Years