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Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations
252 patients around the world
Available in Argentina, Puerto Rico, United States
AbbVie
2Research sites
252Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled into the study.Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy), or appropriate targeted therapy for an actionable gene alteration, if applicable, for epidermal growth factor receptor (EGFR) wild-type (WT) NSq NSCLC.For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration.Must have documented programmed death ligand 1 (PD-L1) status.For Part 2, participant must have evaluable c-Met immunohistochemistry (IHC) result per central testing prior to randomization.Must have adequate organ function.
- Known uncontrolled metastases to the central nervous system.History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.
Sites
Centro Oncológico Korben
Recruiting
Pan American Center for Oncology Trials
Recruiting
SponsorAbbVie
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06772623
