Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
Recruiting · NCT05899608 · Interventional (participants receive a specific treatment) · Lead sponsor: Summit Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
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 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) or Tumor Cells (TC) 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. pericardium, heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.
Where it is running
60 locations listed across 28 US states.
- Banner University Medical Center - Phoenix, Arizona, United States
- TMC Healthcare - Tucson, Arizona, United States
- Genesis Cancer and Blood Institute - Hot Springs, Arkansas, United States
- University of Arkansas - Little Rock, Arkansas, United States
- LA Cancer Network - Anaheim, California, United States
- The Oncology Institute of Hope & Innovation - Cerritos, California, United States
- University of Southern California (USC) - Los Angeles, California, United States
- Cedar Sinai Medical Center - Los Angeles, California, United States
- Valkyrie Clinical Trials - Los Angeles, California, United States
- Sutter Institute for Medical Research - Sacramento, California, United States
- UC Davis Medical Center - Sacramento, California, United States
- University of California Los Angeles (UCLA) - Santa Monica, California, United States
- Providence Medical Foundation - Santa Rosa, California, United States
- Kaiser Permanente - Vallejo, California, United States
- Rocky Mountain Cancer - Lone Tree, Colorado, United States
- Banner MD Anderson Cancer Center at North Colorado Medical Center - Loveland, Colorado, United States
- Hartford Hospital - Hartford, Connecticut, United States
- Yale University - New Haven, Connecticut, United States
- Florida Cancer Specialists & Research Institute (FCS)-East - Fort Myers, Florida, United States
- BioResearch Partner- Hialeah Hospital - Hialeah, Florida, United States
- Memorial Healthcare System - Hollywood, Florida, United States
- Mayo Clinic - Jacksonville, Florida, United States
- Cancer Specialists of North Florida - Jacksonville, Florida, United States
- Ocala Oncology - Ocala, Florida, United States
- Cancer Care of Brevard - Palm Bay, Florida, United States
- Ascension Sacred Heart Health System - Pensacola, Florida, United States
- Exigent Network - Petersburg, Florida, United States
- BRCR Medical Center Inc - Plantation, Florida, United States
- Florida Cancer Specialists & Research Institute (FCS) - North - St. Petersburg, Florida, United States
- BRCR Medical Center Inc. - Tamarac, Florida, United States
- Florida Cancer Specialists & Research Institute (FCS)-South - West Palm Beach, Florida, United States
- Central Georgia Cancer Care - Macon, Georgia, United States
- Northwestern Memorial Hospital - Chicago, Illinois, United States
- Illinois Cancer Care P.C. - Peoria, Illinois, United States
- University of Kansas Cancer Center - Westwood, Kansas, United States
- Baptist Health - Lexington, Kentucky, United States
- Sidney Kimmel Comprehensive Cancer Center - Baltimore, Maryland, United States
- Ascension Saint Agnes Hospital - Baltimore, Maryland, United States
- Lahey Hospital - Burlington, Massachusetts, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Trinity Health - Ann Arbor, Michigan, United States
- Karmanos Cancer Insitute - Detroit, Michigan, United States
- Henry Ford Hospital - Detroit, Michigan, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Park Nicollet Institute - Saint Paul, Minnesota, United States
- American Oncology Partners, PA - Kansas City, Missouri, United States
- Washington University St.Louis - St Louis, Missouri, United States
- St. Vincent Cancer Center - Billings, Montana, United States
- University of Nebraska Medical Center (UNMC) - Omaha, Nebraska, United States
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States
- Mount Sinai - New York, New York, United States
- Memorial Sloan Kettering - New York, New York, United States
- SUNY Upstate Medical University - Syracuse, New York, United States
- University of North Carolina - Chapel Hill, North Carolina, United States
- Levine Center - Charlotte, North Carolina, United States
- Oncology Hematology Care (OHC), Inc - Cincinnati, Ohio, United States
- University Hospitals Case Medical Center - Cleveland, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Willamette Valley Cancer Institute and Research Center (WVCI) - Eugene, Oregon, United States
- Medical University of South Carolina (MUSC) - Charleston, South Carolina, United States
Showing 60 of 260 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →