Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
Purpose
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.
Condition
- Non-Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A - Ivonescimab and chemotherapy |
Subject will receive ivonescimab and chemotherapy |
|
|
Active Comparator Arm B - Pembrolizumab and chemotherapy |
Subject will receive pembrolizumab and chemotherapy |
|
Recruiting Locations
TMC Healthcare
Tucson 5318313, Arizona 5551752 85711
Tucson 5318313, Arizona 5551752 85711
University of Arkansas
Little Rock 4119403, Arkansas 4099753 72205
Little Rock 4119403, Arkansas 4099753 72205
LA Cancer Network
Anaheim 5323810, California 5332921 92801
Anaheim 5323810, California 5332921 92801
The Oncology Institute of Hope & Innovation
Cerritos 5335663, California 5332921 90703
Cerritos 5335663, California 5332921 90703
University of Southern California (USC)
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Cedar Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
Los Angeles 5368361, California 5332921 90048
Valkyrie Clinical Trials
Los Angeles 5368361, California 5332921 90067
Los Angeles 5368361, California 5332921 90067
Sutter Institute for Medical Research
Sacramento 5389489, California 5332921 95816
Sacramento 5389489, California 5332921 95816
UC Davis Medical Center
Sacramento 5389489, California 5332921 95817
Sacramento 5389489, California 5332921 95817
University of California Los Angeles (UCLA)
Santa Monica 5393212, California 5332921 90404
Santa Monica 5393212, California 5332921 90404
Providence Medical Foundation
Santa Rosa 5393287, California 5332921 95403
Santa Rosa 5393287, California 5332921 95403
Kaiser Permanente
Vallejo 5405380, California 5332921 94589
Vallejo 5405380, California 5332921 94589
Rocky Mountain Cancer
Lone Tree 5429208, Colorado 5417618 80124
Lone Tree 5429208, Colorado 5417618 80124
Hartford Hospital
Hartford 4835797, Connecticut 4831725 06053
Hartford 4835797, Connecticut 4831725 06053
Yale University
New Haven 4839366, Connecticut 4831725 06510
New Haven 4839366, Connecticut 4831725 06510
Florida Cancer Specialists & Research Institute (FCS)-East
Fort Myers 4155995, Florida 4155751 33901
Fort Myers 4155995, Florida 4155751 33901
BioResearch Partner- Hialeah Hospital
Hialeah 4158476, Florida 4155751 33013
Hialeah 4158476, Florida 4155751 33013
Cancer Specialists of North Florida
Jacksonville 4160021, Florida 4155751 32256
Jacksonville 4160021, Florida 4155751 32256
Ocala Oncology
Ocala 4166673, Florida 4155751 34474
Ocala 4166673, Florida 4155751 34474
Cancer Care of Brevard
Palm Bay 4167499, Florida 4155751 32901
Palm Bay 4167499, Florida 4155751 32901
Memorial Cancer Institute
Pembroke Pines 4168139, Florida 4155751 33028
Pembroke Pines 4168139, Florida 4155751 33028
Exigent Network
Petersburg, Florida 4155751 33709
Petersburg, Florida 4155751 33709
BRCR
Plantation 4168782, Florida 4155751 33322
Plantation 4168782, Florida 4155751 33322
Florida Cancer Specialists & Research Institute (FCS) - North
St. Petersburg 4171563, Florida 4155751 33705
St. Petersburg 4171563, Florida 4155751 33705
Florida Cancer Specialists & Research Institute (FCS)-South
West Palm Beach 4177887, Florida 4155751 33401
West Palm Beach 4177887, Florida 4155751 33401
Illinois Cancer Care
Peoria 4905687, Illinois 4896861 61615
Peoria 4905687, Illinois 4896861 61615
University of Kansas Cancer Center
Westwood 4281639, Kansas 4273857 66205
Westwood 4281639, Kansas 4273857 66205
Baptist Health
Lexington 4297983, Kentucky 6254925 40503
Lexington 4297983, Kentucky 6254925 40503
Sidney Kimmel Comprehensive Cancer Center
Baltimore 4347778, Maryland 4361885 21187
Baltimore 4347778, Maryland 4361885 21187
Lahey Hospital
Burlington 4931737, Massachusetts 6254926 01805
Burlington 4931737, Massachusetts 6254926 01805
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
Ann Arbor 4984247, Michigan 5001836 48109
Trinity Health
Ann Arbor 4984247, Michigan 5001836 48197
Ann Arbor 4984247, Michigan 5001836 48197
Karmanos Cancer Insitute
Detroit 4990729, Michigan 5001836 48201
Detroit 4990729, Michigan 5001836 48201
Henry Ford Hospital
Detroit 4990729, Michigan 5001836 48202
Detroit 4990729, Michigan 5001836 48202
Park Nicollet Institute
Saint Paul 5045360, Minnesota 5037779 55101
Saint Paul 5045360, Minnesota 5037779 55101
American Oncology Partners, PA
Kansas City 4393217, Missouri 4398678 64132
Kansas City 4393217, Missouri 4398678 64132
Washington University St.Louis
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
St. Vincent Cancer Center
Billings 5640350, Montana 5667009 59102
Billings 5640350, Montana 5667009 59102
University of Nebraska Medical Center (UNMC)
Omaha 5074472, Nebraska 5073708 68105
Omaha 5074472, Nebraska 5073708 68105
Mount Sinai
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10029
Memorial Sloan Kettering
New York 5128581, New York 5128638 10065
New York 5128581, New York 5128638 10065
University of North Carolina
Chapel Hill 4460162, North Carolina 4482348 27514
Chapel Hill 4460162, North Carolina 4482348 27514
Levine Center
Charlotte 4460243, North Carolina 4482348 28204
Charlotte 4460243, North Carolina 4482348 28204
Oncology Hematology Care (OHC), Inc
Cincinnati 4508722, Ohio 5165418 45242
Cincinnati 4508722, Ohio 5165418 45242
University Hospitals Case Medical Center
Cleveland 5150529, Ohio 5165418 44106
Cleveland 5150529, Ohio 5165418 44106
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Cleveland 5150529, Ohio 5165418 44195
Willamette Valley Cancer Institute and Research Center (WVCI)
Eugene 5725846, Oregon 5744337 97401
Eugene 5725846, Oregon 5744337 97401
Medical University of South Carolina (MUSC)
Charleston 4574324, South Carolina 4597040 29425
Charleston 4574324, South Carolina 4597040 29425
Prisma Health-Upstate
Greenville 4580543, South Carolina 4597040 29605
Greenville 4580543, South Carolina 4597040 29605
West Cancer Center
Memphis 4641239, Tennessee 4662168 38138
Memphis 4641239, Tennessee 4662168 38138
SCRI-Nashville
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
Texas Oncology- Austin
Austin 4671654, Texas 4736286 78745
Austin 4671654, Texas 4736286 78745
Texas Oncology-Dallas
Dallas 4684888, Texas 4736286 75246
Dallas 4684888, Texas 4736286 75246
UT Southwestern
Dallas 4684888, Texas 4736286 75390
Dallas 4684888, Texas 4736286 75390
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Texas Oncology-San Antonio
San Antonio 4726206, Texas 4736286 78216
San Antonio 4726206, Texas 4736286 78216
Texas Oncology-Tyler
Tyler 4738214, Texas 4736286 75702
Tyler 4738214, Texas 4736286 75702
University of Texas at Tyler
Tyler 4738214, Texas 4736286 75708
Tyler 4738214, Texas 4736286 75708
Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502
Norfolk 4776222, Virginia 6254928 23502
Virginia Cancer
Reston 4781530, Virginia 6254928 20190
Reston 4781530, Virginia 6254928 20190
Swedish Cancer Institute
Seattle 5809844, Washington 5815135 98103
Seattle 5809844, Washington 5815135 98103
Cancer Care NW Centers
Spokane 5811696, Washington 5815135 99202
Spokane 5811696, Washington 5815135 99202
Carbone Cancer Center
Madison 5261457, Wisconsin 5279468 53792
Madison 5261457, Wisconsin 5279468 53792
More Details
- NCT ID
- NCT05899608
- Status
- Recruiting
- Sponsor
- Summit Therapeutics
Detailed Description
The 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.