DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Thoracic (ONC)
Current Status: Open
Phase: III
Principal Investigator: Abughanimeh, Omar
Contact Information:
Michaela Savine
misavine@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07472517?term=NCT07472517&viewType=Card&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVES
I. The primary objective is to demonstrate superiority in overall survival (OS) in at least 1 of 2 populations: 1) the overall population and 2) the DLL3 high (≥50% TC) population. The stratified logrank test and hazard ratio will be used to determine superiority.
SECONDARY OBJECTIVES
I. The key secondary objectives are to demonstrate superiority in progression-free survival (PFS) and the change from baseline at Week 19 in the dyspnea symptom scale of the European Organization for the Research and Treatment of Cancer supplemental lung cancer module (EORTC QLQ-LC13) in at least 1 of 2 populations: 1) the overall population and 2) the DLL3 high (≥50% TC) population.
II. The secondary objectives are to evaluate whether obrixtamig in combination with atezolizumab, carboplatin, and etoposide vs. atezolizumab, carboplatin, and etoposide in at least 1 of 2 populations (the overall population and the population with the pre-defined DLL3 high [≥50% TC] status) improves objective response (OR) by estimating the odds ratio for the proportion of participants with OR, improves time to deterioration (TTD) of dyspnea, chest pain, and cough scales using EORTC QLQ-LC13 and QLQ-C30, and improves the change from baseline at Week 19 in the EORTC QLQ-LC13 chest pain and cough symptom scales, as well as to assess the safety of these treatment combinations in both populations by descriptively assessing the proportion of participants with occurrences of treatment-emergent CRS, ICANS, treatment-emergent AEs leading to trial medication discontinuation, dose delay, and dose reduction during the on treatment period.