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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899608
• Other study ID #: SMT112-3003
• Status: Recruiting
• Phase: Phase 3
• Start date: October 26, 2023
• Est. completion date: December 20, 2027

Study information

• Verified date: June 2024
• Source: Summit Therapeutics
• Contact: Summit Clinical Trial Information
• Phone: 1-833-256-0522
• Email: medicalinformation[@]smmttx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 20, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 NSCLC
• Tumor Proportion Score (TPS) with PD-L1 expression percent
• At least one measurable noncerebral lesion according to RECIST 1.1
• No prior systemic treatment for metastatic NSCLC

Exclusion Criteria:

• Histologic or cytopathologic evidence of the presence of small cell lung carcinoma, or non-squamous NSCLC histology.
• Known actionable genomic alterations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS1 or genes for which first-line approved therapies are available
• Has received any prior therapy for NSCLC in the metastatic setting
• Tumor invasion, encasement of organs (e.g. heart, trachea, esophagus), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Biological:
• Ivonescimab Injection
Subject will receive ivonescimab and chemotherapy as an IV injection
• Pembrolizumab Injection
Subject will receive pembrolizumab and chemotherapy as an IV injection

Locations

Country	Name	City	State
Canada	Summit Therapeutics Research Center	London	Ontario
Canada	Summit Therapeutics Research Center	Regina	Saskatchewan
United States	Summit Therapeutics Research Center	Albany	New York
United States	Summit Therapeutics Research Center	Austin	Texas
United States	Summit Therapeutics Research Center	Billings	Montana
United States	Summit Therapeutics Research Center	Burlington	Massachusetts
United States	Summit Therapeutics Research Center	Cincinnati	Ohio
United States	Summit Therapeutics Research Center	Cleveland	Ohio
United States	Summit Therapeutics Research Center	Dallas	Texas
United States	Summit Therapeutics Research Center	Detroit	Michigan
United States	Summit Therapeutics Research Center	Eugene	Oregon
United States	Summit Therapeutics Research Center	Fort Myers	Florida
United States	Summit Therapeutics Research Center	Greenville	South Carolina
United States	Summit Therapeutics Research Center	Harlingen	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Summit Therapeutics Research Center	Jacksonville	Florida
United States	Summit Therapeutics Research Center	Lone Tree	Colorado
United States	Summit Therapeutics Research Center	Los Angeles	California
United States	Summit Therapeutics Research Center	Los Angeles	California
United States	Summit Therapeutics Research Center	Madison	Wisconsin
United States	Summit Therapeutics Research Center	Nashville	Tennessee
United States	Summit Therapeutics Research Center	New York	New York
United States	Summit Therapeutics Research Center	Norfolk	Virginia
United States	Summit Therapeutics Research Center	Ocala	Florida
United States	Summit Therapeutics Research Center	Palm Bay	Florida
United States	Summit Therapeutics Research Center	Pensacola	Florida
United States	Summit Therapeutics Research Center	Plantation	Florida
United States	Summit Therapeutics Research Center	Reston	Virginia
United States	Summit Therapeutics Research Center	Sacramento	California
United States	Summit Therapeutics Research Center	Saint Paul	Minnesota
United States	Summit Therapeutics Research Center	Saint Petersburg	Florida
United States	Summit Therapeutics Research Center	Santa Monica	California
United States	Summit Therapeutics Research Center	Spokane	Washington
United States	Summit Therapeutics Research Center	Tallahassee	Florida
United States	Summit Therapeutics Research Center	Tyler	Texas
United States	Summit Therapeutics Research Center	Webster	Texas
United States	Summit Therapeutics Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Summit Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall Survival (OS) in the ITT population	approximately 4 years
Secondary	Progression-Free Survival (PFS)	Progression-free survival (PFS) assessed by investigator based on RECIST v1.1	approximately 4 years
Secondary	Adverse Event (AE)	incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results	From the subject signs the ICF to 30 days (AE) and 90 days (SAE related to ivonescimab/pembrolizumab ) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first, up to 2 years.