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

NCT ID: NCT06767514

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

780 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-27

Study Completion Date

2029-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A - Ivonescimab

Subject will receive ivonescimab as an IV injection

Group Type EXPERIMENTAL

Ivonescimab Injection

Intervention Type BIOLOGICAL

Subject will receive ivonescimab as an IV injection

Arm B - Pembrolizumab

Subject will receive pembrolizumab as an IV injection

Group Type ACTIVE_COMPARATOR

Pembrolizumab Injection

Intervention Type BIOLOGICAL

Subject will receive Pembrolizumab as an IV injection

Interventions

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Ivonescimab Injection

Subject will receive ivonescimab as an IV injection

Intervention Type BIOLOGICAL

Pembrolizumab Injection

Subject will receive Pembrolizumab as an IV injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Summit Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Study Site

Chandler, Arizona, United States

Site Status RECRUITING

Clinical Study Site

Phoenix, Arizona, United States

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Clinical Study Site

Hot Springs, Arkansas, United States

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Clinical Study Site

Cerritos, California, United States

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Clinical Study Site

Los Angeles, California, United States

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Clinical Study Site

Mountain View, California, United States

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Clinical Study Site

San Diego, California, United States

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Clinical Study Site

Aurora, Colorado, United States

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Clinical Study Site

Lone Tree, Colorado, United States

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Clinical Study Site

Loveland, Colorado, United States

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Clinical Study Site

Fort Lauderdale, Florida, United States

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Clinical Study Site

Fort Lauderdale, Florida, United States

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Clinical Study Site

Hialeah, Florida, United States

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Clinical Study Site

Jacksonville, Florida, United States

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Clinical Study Site

Miami, Florida, United States

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North Venice, Florida, United States

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Orlando, Florida, United States

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Clinical Study Site

Pensacola, Florida, United States

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Clinical Study Site

Plantation, Florida, United States

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Clinical Study Site

Tallahassee, Florida, United States

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Clinical Study Site

Tamarac, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Covington, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Detroit, Michigan, United States

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Saint Paul, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Lebanon, New Hampshire, United States

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Mullica Hill, New Jersey, United States

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New Brunswick, New Jersey, United States

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Glen Falls, New York, United States

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Syracuse, New York, United States

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Chapel Hill, North Carolina, United States

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Columbus, Ohio, United States

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Lebanon, Ohio, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Forth Worth, Texas, United States

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Houston, Texas, United States

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Tyler, Texas, United States

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Webster, Texas, United States

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Blacksburg, Virginia, United States

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Vancouver, Washington, United States

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Clinical Study Site

Edmonton, Alberta, Canada

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London, Ontario, Canada

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Montreal, , Canada

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Fuzhou, Fujian, China

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Guangzhou, Guangdong, China

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Haikou, Hainan, China

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Harbin, Heilongjiang, China

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Changzhou, Jiangsu, China

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Ganzhou, Jiangxi, China

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Nanchang, Jiangxi, China

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Tai’an, Shandong, China

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Weifang, Shandong, China

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Shanghai, Shanghai Municipality, China

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Kunming, Yunnan, China

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Hangzhou, Zhejiang, China

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Taizhou, Zhejiang, China

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Wenzhou, Zhejiang, China

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Changchun, , China

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Guangzhou, , China

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Xi'an, , China

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Nantes, Pays de Loire, France

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Brest, , France

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Créteil, , France

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Marseille, , France

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Paris, , France

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Gauting, , Germany

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Karlsruhe, , Germany

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Möser, , Germany

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Athens, , Greece

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Rio, , Greece

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Thessaloniki, , Greece

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Clinical Study Site

Kecskemét, , Hungary

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Roma, , Italy

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Koto-Ku, Tokyo, Japan

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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Veracruz, , Mexico

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Lodz, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Skorzewo, , Poland

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Suceagu, Cluj, Romania

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Baia Mare, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Craiova, , Romania

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Iași, , Romania

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Timișoara, , Romania

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Belgrade, , Serbia

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Novi Sad, , Serbia

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Badajoz, , Spain

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Badalona, , Spain

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Barcelona, , Spain

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Girona, , Spain

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Lugo, , Spain

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Clinical Study Site

Seville, , Spain

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Clinical Study Site

Valencia, , Spain

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Clinical Study Site

Ankara, , Turkey (Türkiye)

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Clinical Study Site

Antalya, , Turkey (Türkiye)

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Clinical Study Site

Diyarbakır, , Turkey (Türkiye)

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Clinical Study Site

Gaziantep, , Turkey (Türkiye)

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Clinical Study Site

Istanbul, , Turkey (Türkiye)

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Clinical Study Site

Istanbul, , Turkey (Türkiye)

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Clinical Study Site

Konya, , Turkey (Türkiye)

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Clinical Study Site

Seyhan, , Turkey (Türkiye)

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Countries

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United States Canada China France Germany Greece Hungary Italy Japan Mexico Poland Romania Serbia Spain Turkey (Türkiye)

Central Contacts

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Summit Clinical Trial Information

Role: CONTACT

[email protected]
1-833-256-0522

Facility Contacts

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Clinical S Site

Role: primary

Clinical Study Site Clinical Study Site

Role: primary

Clinical Study Site Clinical Study Site

Role: primary

Clinical Study Site Clinical Study Site

Role: primary

Other Identifiers

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SMT112-3007

Identifier Type: -

Identifier Source: org_study_id

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