Recruiting

Phase 3

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

Sponsor:

Summit Therapeutics

Code:

NCT06767514

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ivonescimab Injection

Pembrolizumab Injection

Study Details

Brief summary:

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

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT06767514

Start date

Feb 27, 2025

Status verified date

Aug, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

780 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A - Ivonescimab

Subject will receive ivonescimab as an IV injection

active comparator: Arm B - Pembrolizumab

Subject will receive pembrolizumab as an IV injection

Interventions

Ivonescimab Injection

Subject will receive ivonescimab as an IV injection

Pembrolizumab Injection

Subject will receive Pembrolizumab as an IV injection

Primary outcome measure

Overall Survival (OS) [ Time Frame: Up to approximately 36 months ]
Progression free survival (PFS) [ Time Frame: Up to approximately 36 months ]

Central Contacts and Locations

Central contacts

Summit Clinical Trial Information

1-833-256-0522 medicalinformation@smmttx.com

Locations

Clinical Study Site

Recruiting

Chandler, Arizona, United States, 85224

Clinical Study Site

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Phoenix, Arizona, United States, 85006

Clinical Study Site

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Hot Springs, Arkansas, United States, 71913

Clinical Study Sites

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Jonesboro, Arkansas, United States, 72401

Clinical Study Site

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Alameda, California, United States, 90720

Clinical Study Site

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Anaheim, California, United States, 92805

Clinical Study Site

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Beverly Hills, California, United States, 90211

Clinical Study Site

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Cerritos, California, United States, 90703

Clinical Study Site

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Los Angeles, California, United States, 90034

Clinical Study Site

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Los Angeles, California, United States, 90067

Clinical Study Site

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Orange, California, United States, 92868

Clinical Study Site

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Oxnard, California, United States, 93030

Clinical Study Site

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San Diego, California, United States, 92123

Clinical Study Site

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Sunnyvale, California, United States, 94086

Clinical Study Site

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Torrance, California, United States, 90505

Clinical Study Site

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Aurora, Colorado, United States, 80045

Clinical Study Site

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Denver, Colorado, United States, 80210

Clinical Study Site

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Grand Junction, Colorado, United States, 81505

Clinical Study Site

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Lone Tree, Colorado, United States, 80124

Clinical Study Site

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Loveland, Colorado, United States, 80538

Clinical Study Sites

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Fort Lauderdale, Florida, United States, 33308

Clinical Study Site

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Fort Lauderdale, Florida, United States, 33317

Clinical Study Site

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Jacksonville, Florida, United States, 32207

Clinical Study Site

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Jacksonville Beach, Florida, United States, 32256

Clinical Study Site

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North Venice, Florida, United States, 34275

Clinical Study Site

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Orlando, Florida, United States, 32822

Clinical Study Site

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Pensacola, Florida, United States, 32504

Clinical Study Site

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Plantation, Florida, United States, 33323

Clinical Study Site

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Tallahassee, Florida, United States, 32308

Clinical Study Site

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Tamarac, Florida, United States, 33321

Clinical Study Site

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West Palm Beach, Florida, United States, 33401

Clinical Study Site

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Atlanta, Georgia, United States, 30318

Clinical Study Site

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Warner Robins, Georgia, United States, 31088

Clinical Study Site

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Carterville, Illinois, United States, 62918

Clinical Study Site

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Chicago, Illinois, United States, 60611

Clinical Study Site

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Chicago, Illinois, United States, 60612

Clinical Study Site

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Evanston, Illinois, United States, 60201

Clinical Study Site

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Indianapolis, Indiana, United States, 46237

Clinical Study Site

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Waukee, Iowa, United States, 50263

Clinical Study Site

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Lexington, Kentucky, United States, 40503

Clinical Study Site

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Covington, Louisiana, United States, 70433

Clinical Study Site

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Baltimore, Maryland, United States, 21229

Clinical Study Site

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Boston, Massachusetts, United States, 02215

Clinical Study Site

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Brighton, Massachusetts, United States, 21350

Clinical Study Site

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Foxborough, Massachusetts, United States, 02035

Clinical Study Site

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Methuen, Massachusetts, United States, 01844

Clinical Study Site

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Milford, Massachusetts, United States, 01757

Clinical Study Site

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Weymouth, Massachusetts, United States, 02190

Clinical Study Site

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Worcester, Massachusetts, United States, 01655

Clinical Study Site

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Ann Arbor, Michigan, United States, 48109

Clinical Study Site

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Detroit, Michigan, United States, 48201

Clinical Study Sites

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Detroit, Michigan, United States, 48202

Clinical Study Sites

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Duluth, Minnesota, United States, 55805

Clinical Study Site

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Minneapolis, Minnesota, United States, 55455

Clinical Study Site

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Saint Paul, Minnesota, United States, 55101

Clinical Study Site

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Hattiesburg, Mississippi, United States, 39401

Clinical Study Site

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Kansas City, Missouri, United States, 64132

Clinical Study Site

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St Louis, Missouri, United States, 63128

Clinical Study Site

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St Louis, Missouri, United States, 63141

Clinical Study Site

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Lebanon, New Hampshire, United States, 03756

Clinical Study Site

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Mullica Hill, New Jersey, United States, 08062

Clinical Study Site

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New Brunswick, New Jersey, United States, 08901

Clinical Study Site

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New York, New York, United States, 10065

Clinical Study Site

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Syracuse, New York, United States, 13210

Clinical Site

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The Bronx, New York, United States, 10461

Clinical Study Site

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Chapel Hill, North Carolina, United States, 27514

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Durham, North Carolina, United States, 27708

Clinical Study Site

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Pinehurst, North Carolina, United States, 28374

Clinical Study Sites

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Cincinnati, Ohio, United States, 45220

Clinical Study Site

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Cleveland, Ohio, United States, 44195

Clinical Study Sites

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Columbus, Ohio, United States, 43210

Clinical Study Site

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Columbus, Ohio, United States, 43219

Clinical Study Site

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Oklahoma City, Oklahoma, United States, 73102

Clinical Study Site

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Eugene, Oregon, United States, 97401

Clinical Study Site

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Portland, Oregon, United States, 97239

Clinical Study Site

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Philadelphia, Pennsylvania, United States, 19111

Clinical Study Site

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Pittsburgh, Pennsylvania, United States, 15232

Clinical Study Sites

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Nashville, Tennessee, United States, 37203

Clinical Study Site

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Nashville, Tennessee, United States, 37235

Clinical Study Site

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Abilene, Texas, United States, 79601

Clinical Study Site

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Austin, Texas, United States, 78745

Clinical Study Site

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Dallas, Texas, United States, 75246

Clinical Study Site

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Fort Worth, Texas, United States, 76104

Clinical Study Site

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Houston, Texas, United States, 77030

Clinical Study Site

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Tyler, Texas, United States, 75708

Clinical Study Site

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Webster, Texas, United States, 77598

Clinical Study Site

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Salt Lake City, Utah, United States, 84106

Clinical Study Site

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Blacksburg, Virginia, United States, 24061

Clinical Study Site

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Charlottesville, Virginia, United States, 22908

Clinical Study Site

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Fairfax, Virginia, United States, 22031

Clinical Study Site

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Richmond, Virginia, United States, 23229

Clinical Study Site

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Richmond, Virginia, United States, 23298

Clinical Study Site

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Seattle, Washington, United States, 98109

Clinical Study Site

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Vancouver, Washington, United States, 98684

Clinical Study Site

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Edmonton, Alberta, Canada, T6G 1Z2

Clinical Study Site

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Etobicoke, Ontario, Canada, M9V 1R8

Clinical Study Site

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London, Ontario, Canada, N6A 5W9

Clinical Study Site

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Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Summit Therapeutics

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Summit Therapeutics on 2026-08-19.