Last updated 3 months ago
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
1600 patients around the world
Available in Mexico
This study consists of two distinct NSCLC histology cohorts: squamous (N=600) and non-squamous (N=1000), approximately 1600 patients in total. Within each cohort, subjects are randomized in a 1:1 ratio into one of two treatment groups, receiving either ivonescimab or pembrolizumab combined with platinum-doublet chemotherapy. The two histology cohorts will be analyzed independently
Summit Therapeutics
1600Patients 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
- Age ≥ 18 years old at the time of enrollment.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.Expected life expectancy ≥ 3 months.Metastatic (Stage IV) NSCLC.Histologically or cytologically confirmed squamous or non-squamous NSCLC.Recorded measurement of the Tumor Proportion Score (TPS) for PD-L1 expression, irrespective of the PD-L1 expression, prior to randomization.At least one measurable noncerebral lesion according to RECIST 1.1.No prior systemic treatment for metastatic NSCLC.
- Histologic or cytopathologic evidence of the presence of small cell lung carcinoma.Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.For non-squamous histology patients, actionable driver mutation testing results are required before randomization.Has received any prior therapy for NSCLC in the metastatic setting.Tumor invasion, encasement of organs (e.g. heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.
SponsorSummit Therapeutics
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05899608
