Evaluation of Intravenous Telisotuzumab Adizutecan Combined with PD-1 Inhibitors to Treat Advanced Non-Squamous Non-Small Cell Lung Cancer Without Prior Therapy or Actionable Genomic Changes

What this Trial Is About

Non small cell lung carcinoma NSCLC is the most common type of lung cancer and a leading cause of cancer deaths worldwide. This research evaluates the safety and disease activity changes when Telisotuzumab Adizutecan ABBV-400 is given with a PD-1 immune checkpoint inhibitor to adults with advanced or metastatic non-squamous NSCLC without prior advanced disease treatment or actionable genomic changes. The study is divided into two stages and sponsored by AbbVie. In the first stage, participants receive increasing doses of intravenous Telisotuzumab Adizutecan combined with budigalimab until a tolerable and effective dose is found. In the second stage, participants are randomly assigned to one of three groups two groups receive different doses of Telisotuzumab Adizutecan with pembrolizumab, and one group receives a standard of care regimen consisting of pembrolizumab, pemetrexed, and either carboplatin or cisplatin followed by pembrolizumab and pemetrexed. Treatment continues for approximately 33 months. Participants will attend regular visits at a hospital or clinic during the study. Researchers will assess treatment effects through medical evaluations, blood tests, questionnaires, and monitoring of side effects. The main outcomes include dose-limiting toxicities, objective tumor response, and adverse events over up to 33 months. Additional assessments include progression-free survival, duration of response, disease control, and overall survival, with subgroup analyses based on PD-L1 and c-Met status.

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