AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3HARMONi-7NCT06767514

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

A Phase 3 study testing Ivonescimab Injection and Pembrolizumab Injection in people with Non-Small Cell Lung Cancer, run by Summit Therapeutics at 285 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Ivonescimab Injection and Pembrolizumab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
780 participants
Where
285 sitesin 17 countries
Study dates
27 Feb 2025to Jun 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

285 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Summit Clinical Trial Information contact

1-833-256-0522

medicalinformation@smmttx.com

285 sites in 17 countries

United States97 sites, 97 recruiting

  • Clinical Study Site

    Abilene, Texas, 79601

    Recruiting

  • Clinical Study Site

    Alameda, California, 90720

    Recruiting

  • Clinical Study Site

    Anaheim, California, 92805

    Recruiting

  • Clinical Study Site

    Ann Arbor, Michigan, 48109

    Recruiting

  • Clinical Study Site

    Atlanta, Georgia, 30318

    Recruiting

  • Clinical Study Site

    Aurora, Colorado, 80045

    Recruiting

  • Clinical Study Site

    Austin, Texas, 78745

    Recruiting

  • Clinical Study Site

    Baltimore, Maryland, 21229

    Recruiting

  • Clinical Study Site

    Beverly Hills, California, 90211

    Recruiting

  • Clinical Study Site

    Blacksburg, Virginia, 24061

    Recruiting

  • Clinical Study Site

    Boston, Massachusetts, 02215

    Recruiting

  • Clinical Study Site

    Brighton, Massachusetts, 21350

    Recruiting

  • Clinical Study Site

    Carterville, Illinois, 62918

    Recruiting

  • Clinical Study Site

    Cerritos, California, 90703

    Recruiting

  • Clinical Study Site

    Chandler, Arizona, 85224

    Recruiting

  • Clinical Study Site

    Chapel Hill, North Carolina, 27514

    Recruiting

  • Clinical Study Site

    Charlottesville, Virginia, 22908

    Recruiting

  • Clinical Study Site

    Chicago, Illinois, 60611

    Recruiting

  • Clinical Study Site

    Chicago, Illinois, 60612

    Recruiting

  • Clinical Study Sites

    Cincinnati, Ohio, 45220

    Recruiting

  • Clinical Study Site

    Cleveland, Ohio, 44195

    Recruiting

  • Clinical Study Sites

    Columbus, Ohio, 43210

    Recruiting

  • Clinical Study Site

    Columbus, Ohio, 43219

    Recruiting

  • Clinical Study Site

    Covington, Louisiana, 70433

    Recruiting

  • Clinical Study Site

    Dallas, Texas, 75246

    Recruiting

  • Clinical Study Site

    Denver, Colorado, 80210

    Recruiting

  • Clinical Study Site

    Detroit, Michigan, 48201

    Recruiting

  • Clinical Study Sites

    Detroit, Michigan, 48202

    Recruiting

  • Clinical Study Sites

    Duluth, Minnesota, 55805

    Recruiting

  • Clinical Study Site

    Durham, North Carolina, 27708

    Recruiting

  • Clinical Study Site

    Eugene, Oregon, 97401

    Recruiting

  • Clinical Study Site

    Evanston, Illinois, 60201

    Recruiting

  • Clinical Study Site

    Fairfax, Virginia, 22031

    Recruiting

  • Clinical Study Sites

    Fort Lauderdale, Florida, 33308

    Recruiting

  • Clinical Study Site

    Fort Lauderdale, Florida, 33317

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  • Clinical Study Site

    Fort Worth, Texas, 76104

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  • Clinical Study Site

    Foxborough, Massachusetts, 02035

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  • Clinical Study Site

    Grand Junction, Colorado, 81505

    Recruiting

  • Clinical Study Site

    Greenville, South Carolina, 29605

    Recruiting

  • Clinical Study Site

    Hattiesburg, Mississippi, 39401

    Recruiting

  • Clinical Study Site

    Hot Springs, Arkansas, 71913

    Recruiting

  • Clinical Study Site

    Houston, Texas, 77030

    Recruiting

  • Clinical Study Site

    Indianapolis, Indiana, 46237

    Recruiting

  • Clinical Study Site

    Jacksonville, Florida, 32207

    Recruiting

  • Clinical Study Site

    Jacksonville Beach, Florida, 32256

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  • Clinical Study Sites

    Jonesboro, Arkansas, 72401

    Recruiting

  • Clinical Study Site

    Kansas City, Missouri, 64132

    Recruiting

  • Clinical Study Site

    Lebanon, New Hampshire, 03756

    Recruiting

  • Clinical Study Site

    Lexington, Kentucky, 40503

    Recruiting

  • Clinical Study Site

    Lone Tree, Colorado, 80124

    Recruiting

  • Clinical Study Site

    Los Angeles, California, 90034

    Recruiting

  • Clinical Study Site

    Los Angeles, California, 90067

    Recruiting

  • Clinical Study Site

    Loveland, Colorado, 80538

    Recruiting

  • Clinical Study Site

    Methuen, Massachusetts, 01844

    Recruiting

  • Clinical Study Site

    Milford, Massachusetts, 01757

    Recruiting

  • Clinical Study Site

    Minneapolis, Minnesota, 55455

    Recruiting

  • Clinical Study Site

    Mullica Hill, New Jersey, 08062

    Recruiting

  • Clinical Study Sites

    Nashville, Tennessee, 37203

    Recruiting

  • Clinical Study Site

    Nashville, Tennessee, 37235

    Recruiting

  • Clinical Study Site

    New Brunswick, New Jersey, 08901

    Recruiting

  • Clinical Study Site

    New York, New York, 10065

    Recruiting

  • Clinical Study Site

    North Venice, Florida, 34275

    Recruiting

  • Clinical Study Site

    Ocala, Florida, 34474

    Recruiting

  • Clinical Study Site

    Oklahoma City, Oklahoma, 73102

    Recruiting

  • Clinical Study Site

    Orange, California, 92868

    Recruiting

  • Clinical Study Site

    Orlando, Florida, 32822

    Recruiting

  • Clinical Study Site

    Oxnard, California, 93030

    Recruiting

  • Clinical Study Site

    Pensacola, Florida, 32504

    Recruiting

  • Clinical Study Site

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • Clinical Study Site

    Phoenix, Arizona, 85006

    Recruiting

  • Clinical Study Site

    Pinehurst, North Carolina, 28374

    Recruiting

  • Clinical Study Site

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Clinical Study Site

    Plantation, Florida, 33323

    Recruiting

  • Clinical Study Site

    Portland, Oregon, 97239

    Recruiting

  • Clinical Study Site

    Richmond, Virginia, 23229

    Recruiting

  • Clinical Study Site

    Richmond, Virginia, 23298

    Recruiting

  • Clinical Study Site

    Saint Paul, Minnesota, 55101

    Recruiting

  • Clinical Study Site

    Salt Lake City, Utah, 84106

    Recruiting

  • Clinical Study Site

    San Diego, California, 92123

    Recruiting

  • Clinical Study Site

    Seattle, Washington, 98109

    Recruiting

  • Clinical Study Site

    St Louis, Missouri, 63128

    Recruiting

  • Clinical Study Site

    St Louis, Missouri, 63141

    Recruiting

  • Clinical Study Site

    St. Petersburg, Florida, 33709

    Recruiting

  • Clinical Study Site

    Sunnyvale, California, 94086

    Recruiting

  • Clinical Study Site

    Syracuse, New York, 13210

    Recruiting

  • Clinical Study Site

    Tallahassee, Florida, 32308

    Recruiting

  • Clinical Study Site

    Tamarac, Florida, 33321

    Recruiting

  • Clinical Site

    The Bronx, New York, 10461

    Recruiting

  • Clinical Study Site

    Torrance, California, 90505

    Recruiting

  • Clinical Study Site

    Tyler, Texas, 75708

    Recruiting

  • Clinical Study Site

    Vancouver, Washington, 98684

    Recruiting

  • Clinical Study Site

    Warner Robins, Georgia, 31088

    Recruiting

  • Clinical Study Site

    Waukee, Iowa, 50263

    Recruiting

  • Clinical Study Site

    Webster, Texas, 77598

    Recruiting

  • Clinical Study Site

    West Palm Beach, Florida, 33401

    Recruiting

  • Clinical Study Site

    Weymouth, Massachusetts, 02190

    Recruiting

  • Clinical Study Site

    Worcester, Massachusetts, 01655

    Recruiting

Other trials in United States

China34 sites, 34 recruiting

  • Clinical Study Site

    Beijing, Beijing Municipality

    Recruiting

  • Clinical Study Site

    Beijing

    Recruiting

  • Clinical Study Site

    Changchun, Jilin

    Recruiting

  • Clinical Study Site

    Changsha, Hunan

    Recruiting

  • Clinical Site Study

    Changzhou, Jiangsu

    Recruiting

  • Clinical Study Site

    Chengdu, Sichuan

    Recruiting

  • Clinical Study Site

    Fuyang, Anhui

    Recruiting

  • Clinical Study Site

    Fuzhou, Fujian

    Recruiting

  • Clinical Study Site

    Ganzhou, Jiangxi

    Recruiting

  • Clinical Study Site

    Guangzhou, Guangdong

    Recruiting

  • Clinical Study Site

    Guiyang, Guizhou

    Recruiting

  • Clinical Study Site

    Haikou, Hainan

    Recruiting

  • Clinical Study Site

    Hangzhou, Zhejiang

    Recruiting

  • Clinical Study Site

    Harbin, Heilongjiang, 150081

    Recruiting

  • Clinical Study Site

    Hohhot, Inner Mongolia

    Recruiting

  • Clinical Study Site

    Jinan, Shandong

    Recruiting

  • Clinical Study Site

    Kunming, Yunnan

    Recruiting

  • Clinical Study Site

    Luoyang, Henan

    Recruiting

  • Clinical Study Site

    Luzhou, Sichuan

    Recruiting

  • Clinical Study Site

    Nanchang, Jiangxi

    Recruiting

  • Clinical Study Site

    Nanning, Guangxi

    Recruiting

  • Clinical Study Site

    Nanyang, Henan

    Recruiting

  • Clinical Study Site

    Qingdao, Shandong

    Recruiting

  • Clinical Study Site

    Shanghai

    Recruiting

  • Clinical Study Site

    Shenyang, Liaoning

    Recruiting

  • Clinical Study Site

    Tai’an, Shandong

    Recruiting

  • Clinical Study Site

    Taizhou, Zhejiang

    Recruiting

  • Clinical Study Sites

    Tianjin

    Recruiting

  • Clinical Study Site

    Weifang, Shandong

    Recruiting

  • Clinical Study Site

    Weihui, Xinxiang

    Recruiting

  • Clinical Site Study

    Wenzhou, Zhejiang

    Recruiting

  • Clinical Study Site

    Xi’an, Shanxi

    Recruiting

  • Clinical Study Site

    Zhengzhou, Henan

    Recruiting

  • Clinical Study Site

    Zhuzhou, Hunan

    Recruiting

Other trials in China

Spain25 sites, 25 recruiting

  • Clinical Study Site

    A Coruña, 15006

    Recruiting

  • Clinical Study Site

    Badajoz, Extremadura, 06080

    Recruiting

  • Clinical Study Site

    Badalona, 08916

    Recruiting

  • Clinical Study Site

    Barakaldo, Bizkaia, 48903

    Recruiting

  • Clinical Study Site

    Barcelona, Spain, 08003

    Recruiting

  • Clinical Study Site

    Barcelona, Spain, 08908

    Recruiting

  • Clinical Study Site

    Burgos, 09006

    Recruiting

  • Clinical Study Site

    Girona, 17007

    Recruiting

  • Clinical Study Site

    Las Palmas, Las Palmas, 35016

    Recruiting

  • Clinical Study Site

    Lugo, 27002

    Recruiting

  • Clinical Study Site

    Madrid, Madrid, 28007

    Recruiting

  • Clinical Study Site

    Madrid, Madrid, 28040

    Recruiting

  • Clinical Study Site

    Madrid, Martin Lagos, 28040

    Recruiting

  • Clinical Study Site

    Madrid, Spain, 28034

    Recruiting

  • Clinical Study Site

    Madrid, Spain, 28041

    Recruiting

  • Clinical Study Site

    Málaga, 29011

    Recruiting

  • Clinical Study Site

    Marbella, Malaga, 29660

    Recruiting

  • Clinical Study Site

    Santander, Cantabria, 39008

    Recruiting

  • Clinical Study Site

    Sevilla, Madrid, 41014

    Recruiting

  • Clinical Study Site

    Seville, Seville, 41009

    Recruiting

  • Clinical Study Site

    Seville, 41014

    Recruiting

  • Clinical Study Site

    Valencia, 46010

    Recruiting

  • Clinical Study Site

    Valencia, 46026

    Recruiting

  • Clinical Study Site

    Valladolid, 47003

    Recruiting

  • Clinical Study Site

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Japan20 sites, 20 recruiting

  • Clinical Study Site

    Asahikawa, Hokkaido, 078-8510

    Recruiting

  • Clinical Study Site

    Bunkyō-Ku, Tokyo, 113-8677

    Recruiting

  • Clinical Study Site

    Hidaka, Saitama, 350-1298

    Recruiting

  • Clinical Study Site

    Hirakata, Osaka, 573-1191

    Recruiting

  • Clinical Study Site

    Kanazawa, Ishikawa-ken, 920-8641

    Recruiting

  • Clinical Study Site

    Koto-Ku, Tokyo, 135-8550

    Recruiting

  • Clinical Study Site

    Kumamoto, Kumamoto, 861-4193

    Recruiting

  • Clinical Study Site

    Kurume, Fukuoka, 830-0011

    Recruiting

  • Clinical Study Sites

    Kyoto, Kyoto, 602-8566

    Recruiting

  • Clinical Study Site

    Matsusaka, Mie-ken, 515-8544

    Recruiting

  • Clinical Study Site

    Nagoya, Aichi-ken, 460-0001

    Recruiting

  • Clinical Study Site

    Nishinomiya, Hyōgo, 663-8501

    Recruiting

  • Clinical Study Site

    Okayama, Okayama-ken, 700-8558

    Recruiting

  • Clinical Study Site

    Omura-shi, Nagasaki, 856-8562

    Recruiting

  • Clinical Study Site

    Osaka, Osaka, 541-8567

    Recruiting

  • Clinical Study Site

    Sakai, 591-8555

    Recruiting

  • Clinical Study Site

    Sendai, Miyagi, 980-8574

    Recruiting

  • Clinical Study Site

    Shimotsuke, Tochigi, 329-0498

    Recruiting

  • Clinical Study Site

    Tokyo, Japan, 104-0045

    Recruiting

  • Clinical Study Site

    Wakayama, Wakayama, 641-8510

    Recruiting

Other trials in Japan

Turkey (Türkiye)17 sites, 17 recruiting

  • Clinical Study Site

    Adana, 01230

    Recruiting

  • Clinical Study Site

    Ankara, Yenimahalle, 06200

    Recruiting

  • Clinical Study Site

    Ankara, 06010

    Recruiting

  • Clinical Study Site

    Ankara, 06230

    Recruiting

  • Clinical Study Site

    Ankara, 06520

    Recruiting

  • Clinical Study Site

    Ankara, 06590

    Recruiting

  • Clinical Study Site

    Antalya, 07059

    Recruiting

  • Clinical Study Site

    Diyarbakır, 21280

    Recruiting

  • Clinical Study Site

    Gaziantep, 27060

    Recruiting

  • Clinical Study Site

    Istanbul, Bahcelievler, 34180

    Recruiting

  • Clinical Study Site

    Istanbul, 34098

    Recruiting

  • Clinical Study Site

    Istanbul, 34460

    Recruiting

  • Clinical Study Site

    Istanbul, 34722

    Recruiting

  • Clinical Study Site

    Izmir, 35100

    Recruiting

  • Clinical Study Site

    İzmit, 41380

    Recruiting

  • Clinical Study Site

    Konya, 42080

    Recruiting

  • Clinical Study Site

    Seyhan, 01140

    Recruiting

Other trials in Turkey (Türkiye)

Mexico15 sites, 15 recruiting

  • Clinical Study Site

    Aguascalientes, Aguascalientes, 20124

    Recruiting

  • Clinical Study site

    Aguascalientes, 20124

    Recruiting

  • Clinical Study site

    Guadalajara, Jalisco, 44620

    Recruiting

  • Clinical Study Site

    Guadalajara, 44670

    Recruiting

  • Clinical Study Site

    Guadalajara, 44680

    Recruiting

  • Clinical Study Site

    Jalisco, 44680

    Recruiting

  • Clinical Study Site

    Mexico City, 03240

    Recruiting

  • Clinical Study Site

    Mexico City, 06700

    Recruiting

  • Clinical Study Sites

    Mexico City, 10200

    Recruiting

  • Clinical Study Site

    Mexico City, 14080

    Recruiting

  • Clinical Study Site

    Monterrey, 64710

    Recruiting

  • Clinical Study Site

    Oaxaca City, Oaxaca, 68020

    Recruiting

  • Clinical Study Site

    Querétaro, Mexico City, 76269

    Recruiting

  • Clinical Study site

    Veracruz, 20124

    Recruiting

  • Clinical Study Site

    Veracruz, 91900

    Recruiting

Other trials in Mexico

France14 sites, 14 recruiting

  • Clinical Study Site

    Avignon

    Recruiting

  • Clinical Study Site

    Brest, 29200

    Recruiting

  • Clinical Study Site

    Créteil, 94010

    Recruiting

  • Clinical Study Site

    Lille, 59000

    Recruiting

  • Clinical Study Site

    Lyon, 69008

    Recruiting

  • Clinical Study Site

    Marseille, 13000

    Recruiting

  • Clinical Study Site

    Nantes, Pays de Loire, 44277

    Recruiting

  • Clinical Study Site

    Paris, 75020

    Recruiting

  • Clinical Study Site

    Paris, 75248

    Recruiting

  • Clinical Study Site

    Rennes, 35033

    Recruiting

  • Clinical Study Site

    Strasbourg

    Recruiting

  • Clinical Study Site

    Toulon

    Recruiting

  • Clinical Study Site

    Toulouse

    Recruiting

  • Clinical Study Site

    Villejuif, 94800

    Recruiting

Other trials in France

Romania11 sites, 11 recruiting

  • Clinical Study Site

    Baia Mare, Maramureş, 430031

    Recruiting

  • Clinical Study Site

    Bucharest, 022328

    Recruiting

  • Clinical Study Site

    Cluj-Napoca, Cluj, 400015

    Recruiting

  • Clinical Study Site

    Cluj-Napoca, Cluj, 400641

    Recruiting

  • Clinical Study Site

    Cluj-Napoca, Cluj, 407280

    Recruiting

  • Clinical Study Site

    Craiova, Dolj, 200542

    Recruiting

  • Clinical Study Site

    Iași, Iaşi, 700106

    Recruiting

  • Clinical Study Site

    Ovidiu, Constanța County, 905900

    Recruiting

  • Clinical Study Site

    Suceagu, Cluj, 407062

    Recruiting

  • Clinical Study Site

    Timișoara, Timiș County, 300166

    Recruiting

  • Clinical Study Site

    Timișoara, Timiș County, 300425

    Recruiting

Other trials in Romania

Italy10 sites, 10 recruiting

  • Clinical Study Site

    Bari, 70124

    Recruiting

  • Clinical Study Site

    Bergamo, 24125

    Recruiting

  • Clinical Study Site

    Milan, 20037

    Recruiting

  • Clinical Study Site

    Milan, 20133

    Recruiting

  • Clinical Study Site

    Milan, 20141

    Recruiting

  • Clinical Study Sites

    Orbassano, 10043

    Recruiting

  • Clinical Study Site

    Parma, 43126

    Recruiting

  • Clinical Study Site

    Peschiera del Garda, 37019

    Recruiting

  • Clinical Study Site

    Rome, Italy, 00189

    Recruiting

  • Clinical Study Site

    Rome, 00144

    Recruiting

Other trials in Italy

Germany9 sites, 9 recruiting

  • Clinical Study Site

    Chemnitz, 09116

    Recruiting

  • Clinical Study Sites

    Esslingen am Neckar, 73701

    Recruiting

  • Clinical Study Site

    Gauting, 82131

    Recruiting

  • Clinical Study Site

    Giesen, 35392

    Recruiting

  • Clinical Study Site

    Halle, 06120

    Recruiting

  • Clinical Study Site

    Herne, 44651

    Recruiting

  • Clinical Study Site

    Karlsruhe, 76137

    Recruiting

  • Clinical Study Site

    Minden, 32429

    Recruiting

  • Clinical Study Site

    Möser, 47441

    Recruiting

Other trials in Germany

Greece6 sites, 6 recruiting

  • Clinical Study Site

    Athens, 10431

    Recruiting

  • Clinical Study Sites

    Athens, 12462

    Recruiting

  • Clinical Study Site

    Athens, 15562

    Recruiting

  • Clinical Study Sites

    Athens, 18547

    Recruiting

  • Clinical Study Site

    Rio, 26504

    Recruiting

  • Clinical Study Site

    Thessaloniki, 54622

    Recruiting

Other trials in Greece

Portugal6 sites, 6 recruiting

  • Clinical Study Site

    Braga, Braga District, 4710-243

    Recruiting

  • Clinical Study Site

    Coimbra, 3020-479

    Recruiting

  • Clinical Study Site

    Faro, 8000-386

    Recruiting

  • Clinical Study Site

    Lisbon, Lisban, 1400-038

    Recruiting

  • Clinical Study Site

    Porto, Portugal, 4200-072

    Recruiting

  • Clinical Study Site

    Porto, 4099-001

    Recruiting

Other trials in Portugal

Hungary5 sites, 5 recruiting

  • Clinical Study Site

    Budapest, 01121

    Recruiting

  • Clinical Study Site

    Budapest, 01122

    Recruiting

  • Clinical Study Site

    Gyöngyös, 03200

    Recruiting

  • Clinical Study Site

    Gyula, 05700

    Recruiting

  • Clinical Study Site

    Kecskemét, 06000

    Recruiting

Other trials in Hungary

Poland5 sites, 5 recruiting

  • Clinical Study Site

    Gdansk, 80214

    Recruiting

  • Clinical Study Site

    Lodz, 93338

    Recruiting

  • Clinical Study Site

    Lublin, 20064

    Recruiting

  • Clinical Study Site

    Poznan, 60693

    Recruiting

  • Clinical Study Site

    Skorzewo, 60185

    Recruiting

Other trials in Poland

Canada4 sites, 4 recruiting

  • Clinical Study Site

    Edmonton, Alberta, T6G 1Z2

    Recruiting

  • Clinical Study Site

    Etobicoke, Ontario, M9V 1R8

    Recruiting

  • Clinical Study Site

    London, Ontario, N6A 5W9

    Recruiting

  • Clinical Study Site

    Montreal, Quebec, H3T 1E2

    Recruiting

Other trials in Canada

Serbia4 sites, 4 recruiting

  • Clinical Study Site

    Belgrade, 11040

    Recruiting

  • Clinical Study Site

    Belgrade, 11080

    Recruiting

  • Clinical Study Site

    Kragujevac, 34000

    Recruiting

  • Clinical Study Site

    Novi Sad, 21204

    Recruiting

Other trials in Serbia

Belgium3 sites, 3 recruiting

  • Clinical Study Site

    Charleroi, 09600

    Recruiting

  • Clinical Study Site

    Ghent, 09000

    Recruiting

  • Clinical Study Site

    Mons, Hainaut, 07000

    Recruiting

Other trials in Belgium

About this study

Official title: A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression

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

Being tested
Ivonescimab Injection, Pembrolizumab Injection
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ivonescimab InjectionBiological

    Subject will receive ivonescimab as an IV injection

  • Pembrolizumab InjectionBiological

    Subject will receive Pembrolizumab as an IV injection

Study groups in NCT06767514
Study groupRoleWhat they receive
Arm A - IvonescimabExperimentalSubject will receive ivonescimab as an IV injection
Receives: Biological: Ivonescimab Injection
Arm B - PembrolizumabActive comparatorSubject will receive pembrolizumab as an IV injection
Receives: Biological: Pembrolizumab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Measured: Up to approximately 36 months

  2. Progression free survival (PFS)

    Measured: Up to approximately 36 months

Secondary outcomes (4)

  1. Objective response rate (ORR)

    Measured: Up to approximately 36 months

  2. Disease control rate ( DCR)

    Measured: Up to approximately 36 months

  3. Duration of response (DoR)

    Measured: Up to approximately 36 months

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

    Measured: [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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start27 Feb 2025
  3. Primary completionApr 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
780 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06767514
Sponsor's protocol ID
SMT112-3007
Acronym
HARMONi-7
Status last verified
Sep 2026
First submitted
3 Jan 2025
Last updated
18 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ivonescimab Injection and Pembrolizumab Injection in people with Non-Small Cell Lung Cancer, run by Summit Therapeutics at 285 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 285 sites in United States, China, Spain, Japan, Turkey (Türkiye) and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Summit Clinical Trial Information (1-833-256-0522, medicalinformation@smmttx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06767514.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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