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Clinical Trials in Germany / NCT06767514
Recruiting Phase 3

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

NCT06767514 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2025-02-27
Last updated
2026-09-18

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Ivonescimab Injection →Pembrolizumab Injection →

Ivonescimab Injection: Subject will receive ivonescimab as an IV injection

Pembrolizumab Injection: Subject will receive Pembrolizumab as an IV injection

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (285)

FacilityCityRegionStatus
Clinical Study Site Chandler Arizona Recruiting
Clinical Study Site Phoenix Arizona Recruiting
Clinical Study Site Hot Springs Arkansas Recruiting
Clinical Study Sites Jonesboro Arkansas Recruiting
Clinical Study Site Alameda California Recruiting
Clinical Study Site Anaheim California Recruiting
Clinical Study Site Beverly Hills California Recruiting
Clinical Study Site Cerritos California Recruiting
Clinical Study Site Los Angeles California Recruiting
Clinical Study Site Los Angeles California Recruiting
Clinical Study Site Orange California Recruiting
Clinical Study Site Oxnard California Recruiting
Clinical Study Site San Diego California Recruiting
Clinical Study Site Sunnyvale California Recruiting
Clinical Study Site Torrance California Recruiting
Clinical Study Site Aurora Colorado Recruiting
Clinical Study Site Denver Colorado Recruiting
Clinical Study Site Grand Junction Colorado Recruiting
Clinical Study Site Lone Tree Colorado Recruiting
Clinical Study Site Loveland Colorado Recruiting
Clinical Study Sites Fort Lauderdale Florida Recruiting
Clinical Study Site Fort Lauderdale Florida Recruiting
Clinical Study Site Jacksonville Florida Recruiting
Clinical Study Site Jacksonville Beach Florida Recruiting
Clinical Study Site North Venice Florida Recruiting
Clinical Study Site Ocala Florida Recruiting
Clinical Study Site Orlando Florida Recruiting
Clinical Study Site Pensacola Florida Recruiting
Clinical Study Site Plantation Florida Recruiting
Clinical Study Site St. Petersburg Florida Recruiting
Clinical Study Site Tallahassee Florida Recruiting
Clinical Study Site Tamarac Florida Recruiting
Clinical Study Site West Palm Beach Florida Recruiting
Clinical Study Site Atlanta Georgia Recruiting
Clinical Study Site Warner Robins Georgia Recruiting
Clinical Study Site Carterville Illinois Recruiting
Clinical Study Site Chicago Illinois Recruiting
Clinical Study Site Chicago Illinois Recruiting
Clinical Study Site Evanston Illinois Recruiting
Clinical Study Site Indianapolis Indiana Recruiting

+ 245 more sites — see the full list on the official registry below.

More Summit Therapeutics trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06767514 on ClinicalTrials.gov ↗ ← All trials in Germany