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

NCT06767514 | Recruiting Phase 3 FDA Drug

• 1 other identifier: SMT112-3007
• Study Type: interventional
• Target: 780
• Locations: 16 countries
• Sites: 202

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

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  Up to approximately 36 months

• Progression free survival (PFS)

  Up to approximately 36 months

Secondary Outcomes (4)

• Objective response rate (ORR)

  Up to approximately 36 months

• Disease control rate ( DCR)

  Up to approximately 36 months

• Duration of response (DoR)

  Up to approximately 36 months

• Adverse Events (AE): incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results

  [Time Frame: From the subject signs the ICF to 30 days (AE) and 90 days (SAE related to ivonescimab/pembrolizumab ) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first, Up to approximately 24 months.

Study Arms (2)

Arm A - Ivonescimab

EXPERIMENTAL

Subject will receive ivonescimab as an IV injection

Biological: Ivonescimab Injection

Arm B - Pembrolizumab

ACTIVE COMPARATOR

Subject will receive pembrolizumab as an IV injection

Biological: Pembrolizumab Injection

Interventions

Ivonescimab Injection BIOLOGICAL

Subject will receive ivonescimab as an IV injection

Arm A - Ivonescimab

Pembrolizumab Injection BIOLOGICAL

Subject will receive Pembrolizumab as an IV injection

Arm B - Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Summit Therapeutics: lead

Study Sites (202)

Clinical Study Site

Chandler, Arizona, 85224, United States

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Phoenix, Arizona, 85006, United States

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Hot Springs, Arkansas, 71913, United States

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Cerritos, California, 90703, United States

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Glendale, California, 91204, United States

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Irvine, California, 92612, United States

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Los Angeles, California, 90067, United States

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Mountain View, California, 94040, United States

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Murrieta, California, 92562, United States

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Newport Beach, California, 92663, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95816, United States

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San Diego, California, 92123, United States

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San Francisco, California, 94115, United States

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Santa Ana, California, 92705, United States

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Whittier, California, 90602, United States

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Aurora, Colorado, 80045, United States

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Grand Junction, Colorado, 81505, United States

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Greeley, Colorado, 80631, United States

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Lone Tree, Colorado, 80124, United States

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Loveland, Colorado, 80538, United States

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Fort Lauderdale, Florida, 33317, United States

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Hialeah, Florida, 33013, United States

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Jacksonville, Florida, 32256, United States

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Miami, Florida, 33155, United States

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North Venice, Florida, 34275, United States

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Orlando, Florida, 32822, United States

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Pensacola, Florida, 32504, United States

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Plantation, Florida, 33322, United States

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Plantation, Florida, 33323, United States

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Tallahassee, Florida, 32308, United States

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Tamarac, Florida, 33321, United States

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30318, United States

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Macon, Georgia, 30318, United States

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Macon, Georgia, 31210, United States

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Carterville, Illinois, 62918, United States

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Indianapolis, Indiana, 46237, United States

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Waukee, Iowa, 50263, United States

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Lexington, Kentucky, 40503, United States

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Covington, Louisiana, 70433, United States

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Baltimore, Maryland, 21229, United States

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Boston, Massachusetts, 02215, United States

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Milton, Massachusetts, 02186, United States

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Worcester, Massachusetts, 01655, United States

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Detroit, Michigan, 48202, United States

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Detroit, Michigan, 48202, United States

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Lansing, Michigan, 48910, United States

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Minneapolis, Minnesota, 55455, United States

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Saint Louis Park, Minnesota, 55426, United States

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Saint Paul, Minnesota, 55101, United States

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Hattiesburg, Mississippi, 39401, United States

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Kansas City, Missouri, 64132, United States

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St Louis, Missouri, 63128, United States

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Lebanon, New Hampshire, 03756, United States

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Basking Ridge, New Jersey, 07920, United States

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Middletown, New Jersey, 07748, United States

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Montvale, New Jersey, 07645, United States

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Mullica Hill, New Jersey, 08062, United States

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New Brunswick, New Jersey, 08901, United States

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Glen Falls, New York, 12801, United States

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Harrison, New York, 10604, United States

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New York, New York, 10065, United States

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Syracuse, New York, 13210, United States

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Uniondale, New York, 11553, United States

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Chapel Hill, North Carolina, 27592, United States

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Columbus, Ohio, 43219, United States

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Lebanon, Ohio, 45036, United States

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Oklahoma City, Oklahoma, 73102, United States

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Eugene, Oregon, 97401, United States

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Portland, Oregon, 97239, United States

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Philadelphia, Pennsylvania, 19111, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Nashville, Tennessee, 37235, United States

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Abilene, Texas, 79601, United States

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Austin, Texas, 78745, United States

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Dallas, Texas, 75246, United States

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Forth Worth, Texas, 76104, United States

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Houston, Texas, 77030, United States

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Tyler, Texas, 75708, United States

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Webster, Texas, 77598, United States

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Salt Lake City, Utah, 84106, United States

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Blacksburg, Virginia, 24060, United States

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Charlottesville, Virginia, 22908, United States

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Fairfax, Virginia, 22031, United States

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Richmond, Virginia, 23229, United States

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Richmond, Virginia, 23298, United States

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Seattle, Washington, 98109, United States

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Vancouver, Washington, 98684, United States

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Edmonton, Alberta, T6G 1Z2, Canada

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London, Ontario, N6A 5W9, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Montreal, H3T 1E2, 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, 150081, 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, 44277, France

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Brest, 29200, France

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Créteil, 94010, France

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Lyon, 69008, France

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Marseille, 13000, France

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Paris, 75020, France

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Rennes, 35033, France

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Villejuif, 94800, France

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Chemnitz, 91116, Germany

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Gauting, 82131, Germany

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Giesen, 35392, Germany

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Karlsruhe, 76137, Germany

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Minden, 32429, Germany

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Moers, 47441, Germany

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Möser, 47441, Germany

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Athens, 15562, Greece

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Rio, 26504, Greece

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Thessaloniki, 546 22, Greece

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Budapest, 01121, Hungary

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Kecskemét, 6000, Hungary

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Bari, 70124, Italy

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Milan, 20037, Italy

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Milan, 20141, Italy

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Orbassano, 10043, Italy

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Parma, 43126, Italy

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Roma, 00144, Italy

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Asahikawa, Hokkaido, 078-8510, Japan

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Nishinomiya, Hyōgo, 663-8501, Japan

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Matsusaka, Mie-ken, 515-8544, Japan

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Sendai, Miyagi, 980-8574, Japan

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Omura-shi, Nagasaki, 856-8562, Japan

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Hirakata, Osaka, 573-1191, Japan

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Osaka, Osaka, 541-8567, Japan

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Hidaka, Saitama, 350-1298, Japan

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Shimotsuke, Tochigi, 329-0498, Japan

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Bunkyō-Ku, Tokyo, 113-8677, Japan

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Koto-Ku, Tokyo, 135-8550, Japan

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Wakayama, Wakayama, 641-8510, Japan

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Kanazawa, 920-8641, Japan

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Kumamoto, 861-4193, Japan

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Kurume, 830-0011, Japan

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Nagoya, 460-0001, Japan

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Okayama, 700-8558, Japan

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Sakai, 591-8555, Japan

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Tokyo, 104-0045, Japan

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Guadalajara, 44670, Mexico

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Mexico City, 06700, Mexico

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Monterrey, 64710, Mexico

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Veracruz, 91900, Mexico

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Gdansk, 80214, Poland

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Lodz, 93338, Poland

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Lublin, 20064, Poland

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Poznan, 60-693, Poland

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Skorzewo, 60185, Poland

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Braga, 4710-243, Portugal

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Coimbra, 3020-479, Portugal

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Faro, 8000-386, Portugal

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Porto, 4099-001, Portugal

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Suceagu, Cluj, 407062, Romania

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Baia Mare, 430031, Romania

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Bucharest, 22328, Romania

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Cluj-Napoca, 407062, Romania

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Cluj-Napoca, 407280, Romania

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Craiova, 200542, Romania

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Iași, 700106, Romania

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Ovidiu, 905900, Romania

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Timișoara, 300166, Romania

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Belgrade, 11040, Serbia

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Belgrade, 11080, Serbia

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Kragujevac, 34000, Serbia

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Novi Sad, 21204, Serbia

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Badajoz, 06080, Spain

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Badalona, 08916, Spain

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Barcelona, 08003, Spain

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Girona, 17007, Spain

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Las Palmas, 35016, Spain

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Lugo, 27002, Spain

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Madrid, 28040, Spain

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Málaga, 29011, Spain

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Seville, 41014, Spain

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Valencia, 46026, Spain

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Zaragoza, 50009, Spain

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Adana, 01140, Turkey (Türkiye)

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Ankara, 06520, Turkey (Türkiye)

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Antalya, 07059, Turkey (Türkiye)

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Diyarbakır, 21280, Turkey (Türkiye)

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Gaziantep, 27060, Turkey (Türkiye)

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Istanbul, 34460, Turkey (Türkiye)

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Istanbul, 34722, Turkey (Türkiye)

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İzmit, 41380, Turkey (Türkiye)

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Konya, 42080, Turkey (Türkiye)

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Seyhan, 07059, Turkey (Türkiye)

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Summit Clinical Trial Information

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 10, 2025
• Study Start: February 27, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

PT (4); RO (9); HU (2); ME (4); IT (6); JP (19); DE (7); PL (5); CA (4); TU (10); FR (8); GR (3); ES (11); US (89); CN (17); SE (4)