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

Recruiting · NCT06767514 · Interventional (participants receive a specific treatment) · Lead sponsor: Summit Therapeutics

View the official record on ClinicalTrials.gov →

Lung cancer

Interventions studied

Ivonescimab Injection Pembrolizumab Injection

What this trial is about

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

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

60 locations listed across 30 US states.

Clinical Study Site - Chandler, Arizona, United States
Clinical Study Site - Phoenix, Arizona, United States
Clinical Study Site - Hot Springs, Arkansas, United States
Clinical Study Sites - Jonesboro, Arkansas, United States
Clinical Study Site - Alameda, California, United States
Clinical Study Site - Anaheim, California, United States
Clinical Study Site - Beverly Hills, California, United States
Clinical Study Site - Cerritos, California, United States
Clinical Study Site - Los Angeles, California, United States
Clinical Study Site - Los Angeles, California, United States
Clinical Study Site - Orange, California, United States
Clinical Study Site - Oxnard, California, United States
Clinical Study Site - San Diego, California, United States
Clinical Study Site - Sunnyvale, California, United States
Clinical Study Site - Torrance, California, United States
Clinical Study Site - Aurora, Colorado, United States
Clinical Study Site - Denver, Colorado, United States
Clinical Study Site - Grand Junction, Colorado, United States
Clinical Study Site - Lone Tree, Colorado, United States
Clinical Study Site - Loveland, Colorado, United States
Clinical Study Sites - Fort Lauderdale, Florida, United States
Clinical Study Site - Fort Lauderdale, Florida, United States
Clinical Study Site - Jacksonville, Florida, United States
Clinical Study Site - Jacksonville Beach, Florida, United States
Clinical Study Site - North Venice, Florida, United States
Clinical Study Site - Orlando, Florida, United States
Clinical Study Site - Pensacola, Florida, United States
Clinical Study Site - Plantation, Florida, United States
Clinical Study Site - Tallahassee, Florida, United States
Clinical Study Site - Tamarac, Florida, United States
Clinical Study Site - West Palm Beach, Florida, United States
Clinical Study Site - Atlanta, Georgia, United States
Clinical Study Site - Warner Robins, Georgia, United States
Clinical Study Site - Carterville, Illinois, United States
Clinical Study Site - Chicago, Illinois, United States
Clinical Study Site - Chicago, Illinois, United States
Clinical Study Site - Evanston, Illinois, United States
Clinical Study Site - Indianapolis, Indiana, United States
Clinical Study Site - Waukee, Iowa, United States
Clinical Study Site - Lexington, Kentucky, United States
Clinical Study Site - Covington, Louisiana, United States
Clinical Study Site - Baltimore, Maryland, United States
Clinical Study Site - Boston, Massachusetts, United States
Clinical Study Site - Brighton, Massachusetts, United States
Clinical Study Site - Foxborough, Massachusetts, United States
Clinical Study Site - Methuen, Massachusetts, United States
Clinical Study Site - Milford, Massachusetts, United States
Clinical Study Site - Weymouth, Massachusetts, United States
Clinical Study Site - Worcester, Massachusetts, United States
Clinical Study Site - Ann Arbor, Michigan, United States
Clinical Study Site - Detroit, Michigan, United States
Clinical Study Sites - Detroit, Michigan, United States
Clinical Study Sites - Duluth, Minnesota, United States
Clinical Study Site - Minneapolis, Minnesota, United States
Clinical Study Site - Saint Paul, Minnesota, United States
Clinical Study Site - Hattiesburg, Mississippi, United States
Clinical Study Site - Kansas City, Missouri, United States
Clinical Study Site - St Louis, Missouri, United States
Clinical Study Site - St Louis, Missouri, United States
Clinical Study Site - Lebanon, New Hampshire, United States

Showing 60 of 274 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →