Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
Categories (click each to see list of all clinical trials associated with that category): Thoracic (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Abughanimeh, Omar
Contact Information:
Kimberly Shields
kimberly.shields@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05899608?term=NCT05899608&rank=1#participation-criteria
Summary
Primary Objective
To compare overall survival (OS) between ivonescimab combined with carboplatin and paclitaxel or nab-paclitaxel
versus pembrolizumab combined with carboplatin and paclitaxel or nab-paclitaxel
Secondary Objectives
To compare investigator assessed progression-free survival (PFS) based on Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1 between ivonescimab combined with carboplatin and paclitaxel or nab-paclitaxel and
pembrolizumab combined with carboplatin and paclitaxel or nab-paclitaxel
To compare the objective response rate (ORR) and duration of response (DoR) between ivonescimab combined with
carboplatin and paclitaxel or nab-paclitaxel versus pembrolizumab combined with carboplatin and paclitaxel or
nab-paclitaxel, as assessed by investigator, based on RECIST v1.1
To evaluate the safety and tolerability of ivonescimab in combination with carboplatin and paclitaxel or
nab-paclitaxel and compare to pembrolizumab combined with carboplatin and paclitaxel or nab-paclitaxel
To evaluate the pharmacokinetic (PK) profile of ivonescimab in combination with carboplatin and paclitaxel or
nab-paclitaxel
To evaluate the immunogenicity of ivonescimab Exploratory Objectives
To explore potential tumor-specific biomarkers in tumor tissue and peripheral blood samples
To evaluate central nervous system (CNS) metastases response in patients with CNS metastasis at baseline
To evaluate health-related quality-of-life (HRQoL) measures of ivonescimab combined with carboplatin and
paclitaxel or nab-paclitaxel versus pembrolizumab combined with carboplatin and paclitaxel or nab-paclitaxel