Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1

Phase 3

Recruiting

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

• Registration Number: NCT06767514
• Lead Sponsor: Summit Therapeutics

Brief Summary

Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-10
• Study Start: 2025-02-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Primary Completion: 2028-04
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

• Age ≥ 18 years old at the time of enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
• Expected life expectancy ≥ 3 months
• Metastatic (Stage IV) NSCLC
• Histologically or cytologically confirmed squamous or non-squamous NSCLC
• Tumor demonstrates high PD-L1 expression ( TPS>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities.
• 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 for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.
• Has received any prior therapy for NSCLC in the metastatic setting.
• Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.
• Known actionable genomic alterations for which first-line approved therapies are indicated
• Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease
• Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization
• Active autoimmune or lung disease requiring systemic therapy
• Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
• Severe infection within 4 weeks prior to randomization
• Major surgical procedures or serious trauma within 4 weeks prior to randomization
• History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A - Ivonescimab	Ivonescimab Injection	Subject will receive ivonescimab as an IV injection
Arm B - Pembrolizumab	Pembrolizumab Injection	Subject will receive pembrolizumab as an IV injection

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	Up to approximately 36 months
Overall Survival (OS)	Up to approximately 36 months

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to approximately 36 months
Disease control rate ( DCR)	Up to approximately 36 months
Duration of response (DoR)	Up to approximately 36 months
Adverse Events (AE): incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results	[Time Frame: 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 approximately 24 months.

Trial Locations

Locations (1)

Clinical Study Site; 🇺🇸 Webster, Texas, United States