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

Purpose

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

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 - 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

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

ArmDescriptionAssigned Intervention
Experimental
Arm A - Ivonescimab 		Subject will receive ivonescimab as an IV injection
  • Biological: Ivonescimab Injection
    Subject will receive ivonescimab as an IV injection
Active Comparator
Arm B - Pembrolizumab 		Subject will receive pembrolizumab as an IV injection
  • Biological: Pembrolizumab Injection
    Subject will receive Pembrolizumab as an IV injection

Recruiting Locations

Clinical Study Site
Chandler, Arizona 85224

Clinical Study Site
Phoenix, Arizona 85006

Clinical Study Site
Hot Springs, Arkansas 71913

Clinical Study Sites
Jonesboro, Arkansas 72401

Clinical Study Site
Alameda, California 90720

Clinical Study Site
Anaheim, California 92805

Clinical Study Site
Beverly Hills, California 90211

Clinical Study Site
Cerritos, California 90703

Clinical Study Site
Los Angeles, California 90034

Clinical Study Site
Los Angeles, California 90067

Clinical Study Site
Orange, California 92868

Clinical Study Site
Oxnard, California 93030

Clinical Study Site
San Diego, California 92123

Clinical Study Site
Sunnyvale, California 94086

Clinical Study Site
Torrance, California 90505

Clinical Study Site
Aurora, Colorado 80045

Clinical Study Site
Denver, Colorado 80210

Clinical Study Site
Grand Junction, Colorado 81505

Clinical Study Site
Lone Tree, Colorado 80124

Clinical Study Site
Loveland, Colorado 80538

Clinical Study Sites
Fort Lauderdale, Florida 33308

Clinical Study Site
Fort Lauderdale, Florida 33317

Clinical Study Site
Jacksonville, Florida 32207

Clinical Study Site
Jacksonville Beach, Florida 32256

Clinical Study Site
North Venice, Florida 34275

Clinical Study Site
Orlando, Florida 32822

Clinical Study Site
Pensacola, Florida 32504

Clinical Study Site
Plantation, Florida 33323

Clinical Study Site
Tallahassee, Florida 32308

Clinical Study Site
Tamarac, Florida 33321

Clinical Study Site
West Palm Beach, Florida 33401

Clinical Study Site
Atlanta, Georgia 30318

Clinical Study Site
Warner Robins, Georgia 31088

Clinical Study Site
Carterville, Illinois 62918

Clinical Study Site
Chicago, Illinois 60611

Clinical Study Site
Chicago, Illinois 60612

Clinical Study Site
Evanston, Illinois 60201

Clinical Study Site
Indianapolis, Indiana 46237

Clinical Study Site
Waukee, Iowa 50263

Clinical Study Site
Lexington, Kentucky 40503

Clinical Study Site
Covington, Louisiana 70433

Clinical Study Site
Baltimore, Maryland 21229

Clinical Study Site
Boston, Massachusetts 02215

Clinical Study Site
Brighton, Massachusetts 21350

Clinical Study Site
Foxborough, Massachusetts 02035

Clinical Study Site
Methuen, Massachusetts 01844

Clinical Study Site
Milford, Massachusetts 01757

Clinical Study Site
Weymouth, Massachusetts 02190

Clinical Study Site
Worcester, Massachusetts 01655

Clinical Study Site
Ann Arbor, Michigan 48109

Clinical Study Site
Detroit, Michigan 48201

Clinical Study Sites
Detroit, Michigan 48202

Clinical Study Sites
Duluth, Minnesota 55805

Clinical Study Site
Minneapolis, Minnesota 55455

Clinical Study Site
Saint Paul, Minnesota 55101

Clinical Study Site
Hattiesburg, Mississippi 39401

Clinical Study Site
Kansas City, Missouri 64132

Clinical Study Site
St Louis, Missouri 63128

Clinical Study Site
St Louis, Missouri 63141

Clinical Study Site
Lebanon, New Hampshire 03756

Clinical Study Site
Mullica Hill, New Jersey 08062

Clinical Study Site
New Brunswick, New Jersey 08901

Clinical Study Site
New York, New York 10065

Clinical Study Site
Syracuse, New York 13210

Clinical Site
The Bronx, New York 10461

Clinical Study Site
Chapel Hill, North Carolina 27514

Clinical Study Site
Durham, North Carolina 27708

Clinical Study Site
Pinehurst, North Carolina 28374

Clinical Study Sites
Cincinnati, Ohio 45220

Clinical Study Site
Cleveland, Ohio 44195

Clinical Study Sites
Columbus, Ohio 43210

Clinical Study Site
Columbus, Ohio 43219

Clinical Study Site
Oklahoma City, Oklahoma 73102

Clinical Study Site
Eugene, Oregon 97401

Clinical Study Site
Portland, Oregon 97239

Clinical Study Site
Philadelphia, Pennsylvania 19111

Clinical Study Site
Pittsburgh, Pennsylvania 15232

Clinical Study Sites
Nashville, Tennessee 37203

Clinical Study Site
Nashville, Tennessee 37235

Clinical Study Site
Abilene, Texas 79601

Clinical Study Site
Austin, Texas 78745

Clinical Study Site
Dallas, Texas 75246

Clinical Study Site
Fort Worth, Texas 76104

Clinical Study Site
Houston, Texas 77030

Clinical Study Site
Tyler, Texas 75708

Clinical Study Site
Webster, Texas 77598

Clinical Study Site
Salt Lake City, Utah 84106

Clinical Study Site
Blacksburg, Virginia 24061

Clinical Study Site
Charlottesville, Virginia 22908

Clinical Study Site
Fairfax, Virginia 22031

Clinical Study Site
Richmond, Virginia 23229

Clinical Study Site
Richmond, Virginia 23298

Clinical Study Site
Seattle, Washington 98109

Clinical Study Site
Vancouver, Washington 98684

More Details

Status
Recruiting
Sponsor
Summit Therapeutics

Study Contact

Summit Clinical Trial Information
1-833-256-0522
medicalinformation@smmttx.com