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

Phase 3

Recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Biological: Ivonescimab Injection; Biological: Pembrolizumab Injection

• Registration Number: NCT05899608
• Lead Sponsor: Summit Therapeutics

Brief 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

Not available

Study Timeline

• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-12
• Study Start: 2023-10-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1080

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 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A - Ivonescimab and chemotherapy	Ivonescimab Injection	Subject will receive ivonescimab and chemotherapy
Arm B - Pembrolizumab and chemotherapy	Pembrolizumab Injection	Subject will receive pembrolizumab and chemotherapy

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	approximately 6 years	Overall Survival (OS) in the ITT population
Progression Free Survival (PFS)	approximately 3 years	Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1

Secondary Outcome Measures

Name	Time	Method
Adverse Event (AE)	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 anticancer therapy, whichever occurs first, up to 2 years.	incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results

Trial Locations

Locations (3)

Clinical Study Site; 🇬🇧 Manchester, United Kingdom

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Summit Therapeutics Research Center; 🇪🇸 Valencia, Spain