NCT05899608

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients

A Randomized, Double-blind, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer (HARMONi-3)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,600 (estimated)
• Sponsor: Summit Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.

Detailed description

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

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Ivonescimab Injection	Subject will receive ivonescimab and chemotherapy as an IV injection
BIOLOGICAL	Pembrolizumab Injection	Subject will receive pembrolizumab and chemotherapy as an IV injection

Timeline

• Start date: 2023-10-26
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2023-06-12
• Last updated: 2026-01-07

Locations

244 sites across 17 countries: United States, Belgium, Canada, China, France, Germany, Greece, Ireland, Italy, Japan, Mexico, Poland, Serbia, Spain, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study