Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
Trial Status: active
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT05899608.
Locations matching your search criteria
United States
California
Los Angeles
Keck Medicine of USC Koreatown
Status: Active
Contact: Bomi Choi
Phone: 813-506-9486
Email: bomi.choi@med.usc.edu
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Joanna Gabriela Gutierrez
Phone: 310-633-8400
Email: JGGutierrez@mednet.ucla.edu
Los Angeles General Medical Center
Status: Active
Contact: Sandy Tran
Phone: 323-865-3935
Email: sandy.tran@med.usc.edu
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Sandy Tran
Phone: 323-865-3935
Email: sandy.tran@med.usc.edu
Newport Beach
USC Norris Oncology/Hematology-Newport Beach
Status: Active
Contact: Kristy Marie Massopust
Phone: 949-646-6441
Email: sartor@usc.edu
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not AvailableConnecticut
Derby
Smilow Cancer Hospital-Derby Care Center
Status: Active
Name Not AvailableFairfield
Smilow Cancer Hospital Care Center-Fairfield
Status: Active
Name Not AvailableGreenwich
Smilow Cancer Hospital Care Center at Greenwich
Status: Active
Name Not AvailableGuilford
Smilow Cancer Hospital Care Center - Guilford
Status: Active
Name Not AvailableNew Haven
Yale University
Status: Active
Name Not AvailableStamford
Smilow Cancer Hospital Care Center at Long Ridge
Status: Active
Name Not AvailableTorrington
Smilow Cancer Hospital-Torrington Care Center
Status: Active
Name Not AvailableTrumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not AvailableWaterbury
Smilow Cancer Hospital-Waterbury Care Center
Status: Active
Name Not AvailableWaterford
Smilow Cancer Hospital Care Center - Waterford
Status: Active
Name Not AvailableIllinois
Shiloh
Memorial Hospital East
Status: Active
Name Not AvailableMaryland
Baltimore
Johns Hopkins Bayview Medical Center
Status: Active
Contact: Aliyah Pabani
Phone: 410-502-3820
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not AvailableMichigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not AvailableDetroit
Wayne State University/Karmanos Cancer Institute
Status: Active
Name Not AvailableMinnesota
Minneapolis
University of Minnesota/Masonic Cancer Center
Status: Approved
Name Not AvailableMissouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not AvailableNebraska
Omaha
University of Nebraska Medical Center
Status: Active
Name Not AvailableNew York
New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not AvailableMemorial Sloan Kettering Cancer Center
Status: Active
Name Not AvailableNorth Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not AvailableCharlotte
Carolinas Medical Center/Levine Cancer Institute
Status: Active
Name Not AvailableOhio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not AvailableRhode Island
Westerly
Smilow Cancer Hospital Care Center - Westerly
Status: Active
Name Not AvailableSouth Carolina
Charleston
Medical University of South Carolina
Status: Active
Name Not AvailableTexas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not AvailableHouston
M D Anderson Cancer Center
Status: Active
Name Not AvailableWisconsin
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Status: Active
Contact: Howard H. Bailey
Email: hhbailey@wisc.edu
University of Wisconsin Carbone Cancer Center - University Hospital
Status: Active
Name Not AvailableThe study will enroll approximately 1080 patients randomized in a 1:1 ratio for
ivonescimab or pembrolizumab combined with platinum-doublet chemotherapy. The study will
enroll 45-50% of patients with NSCLC squamous histology and 50-55 % of patients with
NSCLC non-squamous histology.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationSummit Therapeutics
- Primary IDSMT112-3003
- Secondary IDsNCI-2023-08387
- ClinicalTrials.gov IDNCT05899608