Phase III Study Comparing Datopotamab Deruxtecan and Docetaxel in Adults with Previously Treated TROP2-Positive Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Targetable Genetic Changes

What this Trial Is About

Researchers are evaluating the safety and effectiveness of datopotamab deruxtecan Dato-DXd compared with docetaxel in patients with advanced or metastatic non-squamous non-small cell lung cancer NSCLC that tests positive for trophoblast cell surface protein 2 TROP2 but lacks actionable genomic alterations. This phase III, randomized, open-label study also aims to assess the clinical performance of an investigational diagnostic test related to TROP2 expression. Participants will be randomly assigned to receive either Dato-DXd or docetaxel as an intravenous infusion every three weeks. Each treatment is given on Day 1 of a 21-day cycle. The study includes two groups one receiving Dato-DXd monotherapy and the other receiving docetaxel monotherapy. The study will continue until disease progression or other discontinuation criteria are met. Throughout the study, participants will undergo regular assessments to measure progression-free survival and overall survival over approximately 2.5 to 3.5 years. Additional evaluations include response rates, duration of response, symptom assessments, quality of life questionnaires, and biomarker analyses. Safety monitoring and diagnostic testing will also be conducted. The total participation time will depend on individual treatment duration and follow-up requirements.

Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations