RecruitingPhase 2Phase 3NCT07100080

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy


Sponsor

Bristol-Myers Squibb

Enrollment

596 participants

Start Date

Nov 5, 2025

Study Type

INTERVENTIONAL

Summary

A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Non-squamous NSCLC, not amenable to treatment in curative intent.
  • Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).
  • Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.
  • Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).

Exclusion Criteria3

  • Inadequate organ function and/or bone marrow reserve.
  • Leptomeningeal metastases or spinal cord compression.
  • Poorly controlled systemic medical conditions.

Interventions

DRUGIza-bren

Specified dose on specified days

DRUGCarboplatin

Specified dose on specified days

DRUGCisplatin

Specified dose on specified days

DRUGPemetrexed

Specified dose on specified days


Locations(185)

Local Institution - 0025

Houston, Texas, United States

Local Institution - 0279

Irvine, California, United States

Local Institution - 0154

Orange, California, United States

Shaw Cancer Center

Edwards, Colorado, United States

Local Institution - 0085

Gainesville, Florida, United States

Local Institution - 0270

Atlanta, Georgia, United States

Local Institution - 0143

Columbus, Georgia, United States

Local Institution - 0153

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Local Institution - 0276

Reno, Nevada, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, United States

NYU Langone Health

New York, New York, United States

Local Institution - 0158

New York, New York, United States

Local Institution - 0186

Rochester, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Local Institution - 0284

Columbus, Ohio, United States

Local Institution - 0038

Portland, Oregon, United States

Local Institution - 0275

Portland, Oregon, United States

Local Institution - 0171

Portland, Oregon, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Local Institution - 0088

Pittsburgh, Pennsylvania, United States

Local Institution - 0268

Chattanooga, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Local Institution - 0173

San Antonio, Texas, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Local Institution - 0138

Richmond, Virginia, United States

Local Institution - 0008

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0004

ABB, Buenos Aires F.D., Argentina

Local Institution - 0094

Córdoba, Córdoba Province, Argentina

Local Institution - 0280

Wilrijk, Antwerpen, Belgium

Local Institution - 0161

Auderghem, Bruxelles-Capitale, Région de, Belgium

Local Institution - 0022

Yvoir, Namur, Belgium

Local Institution - 0023

Ghent, Oost-Vlaanderen, Belgium

Local Institution - 0024

Sint-Niklaas, Oost-Vlaanderen, Belgium

Local Institution - 0190

Calgary, Alberta, Canada

Local Institution - 0183

Toronto, Ontario, Canada

Local Institution - 0184

Chicoutimi, Quebec, Canada

Local Institution - 0185

Montreal, Quebec, Canada

Local Institution - 0006

Santiago, Santiago Metropolitan, Chile

Local Institution - 0005

Santiago, Santiago Metropolitan, Chile

Local Institution - 0007

Santiago, Santiago Metropolitan, Chile

Local Institution - 0244

Beijing, Beijing Municipality, China

Local Institution - 0259

Chongqing, Chongqing Municipality, China

Local Institution - 0253

Fuzhou, Fujian, China

Local Institution - 0245

Jiangmen, Guangdong, China

Local Institution - 0271

Anyang, Henan, China

Local Institution - 0261

Luoyang, Henan, China

Local Institution - 0267

Jingzhou, Hubei, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

Local Institution - 0255

Changsha, Hunan, China

Local Institution - 0256

Xuzhou, Jiangsu, China

Local Institution - 0247

Nanchang, Jiangxi, China

Local Institution - 0246

Changchun, Jilin, China

Local Institution - 0257

Shenyang, Liaoning, China

Local Institution - 0248

Jinan, Shandong, China

Local Institution - 0250

Shanghai, Shanghai Municipality, China

Local Institution - 0258

Taiyuan, Shanxi, China

Local Institution - 0252

Hangzhou, Zhejiang, China

Local Institution - 0251

Linhai, Zhejiang, China

Local Institution - 0260

Nanning, China

Local Institution - 0249

Shanghai, China

Local Institution - 0229

Valledupar, Cesar Department, Colombia

Local Institution - 0228

Bogotá, Cundinamarca, Colombia

Local Institution - 0227

Montería, Departamento de Córdoba, Colombia

Local Institution - 0226

Cali, Valle del Cauca Department, Colombia

Local Institution - 0014

Strasbourg, Alsace, France

Local Institution - 0017

Toulouse, Haute-Garonne, France

Local Institution - 0010

Lille, Hauts-de-France, France

Local Institution - 0018

La Tronche, Isère, France

Local Institution - 0170

Saint-Herblain, Loire-Atlantique, France

Local Institution - 0162

Bron, Rhône, France

Local Institution - 0019

Villejuif, Val-de-Marne, France

Local Institution - 0012

Marseille, France

Local Institution - 0278

Nantes, France

Local Institution - 0011

Paris, France

Local Institution - 0015

Paris, France

Local Institution - 0207

Esslingen am Neckar, Baden-Wurttemberg, Germany

Local Institution - 0238

Esslingen am Neckar, Baden-Wurttemberg, Germany

Local Institution - 0212

Stuttgart, Baden-Wurttemberg, Germany

Local Institution - 0236

Donauwörth, Bavaria, Germany

Local Institution - 0209

Oldenburg, Lower Saxony, Germany

Local Institution - 0213

Cologne, North Rhine-Westphalia, Germany

Local Institution - 0208

Chemnitz, Saxony, Germany

Local Institution - 0274

Kiel, Schleswig-Holstein, Germany

Local Institution - 0211

Berlin, Germany

Local Institution - 0215

Gauting, Germany

Local Institution - 0242

Hamburg, Germany

Local Institution - 0210

Heidelberg, Germany

Local Institution - 0239

Kassel, Germany

Local Institution - 0241

Ulm, Germany

Local Institution - 0054

Athens, Attikí, Greece

Local Institution - 0060

Chaïdári, Attikí, Greece

Local Institution - 0056

Thessaloniki, Kentrikí Makedonía, Greece

Local Institution - 0062

Thessaloniki, Thessaloníki, Greece

Local Institution - 0083

Ahmedabad, Gujarat, India

Local Institution - 0073

Ahmedabad, Gujarat, India

Local Institution - 0072

Gurugram, Haryana, India

Local Institution - 0069

Bengaluru, Karnataka, India

Local Institution - 0077

Mumbai, Maharashtra, India

Local Institution - 0071

Mumbai, Maharashtra, India

Local Institution - 0097

Nagpur, Maharashtra, India

Local Institution - 0070

New Delhi, National Capital Territory of Delhi, India

Local Institution - 0078

Howrah, West Bengal, India

Local Institution - 0028

Ravenna, Emilia-Romagna, Italy

Local Institution - 0036

Aviano, Friuli Venezia Giulia, Italy

Local Institution - 0031

Orbassano, Piedmont, Italy

Local Institution - 0277

Candiolo, Torino, Italy

Local Institution - 0137

Avellino, Italy

Local Institution - 0032

Milan, Italy

Local Institution - 0034

Napoli, Italy

Local Institution - 0029

Parma, Italy

Local Institution - 0196

Nagoya, Aichi-ken, Japan

Local Institution - 0191

Kashiwa, Chiba, Japan

Local Institution - 0203

Tōon, Ehime, Japan

Local Institution - 0201

Kurume, Fukuoka, Japan

Local Institution - 0217

Sapporo, Hokkaido, Japan

Local Institution - 0199

Nishinomiya, Hyōgo, Japan

Local Institution - 0193

Yokohama, Kanagawa, Japan

Local Institution - 0192

Sendai, Miyagi, Japan

Local Institution - 0200

Kurashiki, Okayama-ken, Japan

Local Institution - 0198

Hirakata, Osaka, Japan

Local Institution - 0204

Ōsaka-sayama, Osaka, Japan

Local Institution - 0194

Ina-machi, Saitama, Japan

Local Institution - 0197

Hamamatsu, Shizuoka, Japan

Local Institution - 0195

Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

Local Institution - 0202

Koto-ku, Tokyo, Japan

Local Institution - 0225

Mexico City, Mexico City, Mexico

Local Institution - 0224

Oaxaca City, Oaxaca, Mexico

Local Institution - 0222

Chihuahua City, Mexico

Local Institution - 0223

Mexico City, Mexico

Local Institution - 0163

Harderwijk, Gelderland, Netherlands

Local Institution - 0216

Amsterdam, North Holland, Netherlands

Local Institution - 0164

Amsterdam, North Holland, Netherlands

Local Institution - 0103

Drammen, Buskerud, Norway

Local Institution - 0106

Bergen, Hordaland, Norway

Local Institution - 0105

Oslo, Norway

Local Institution - 0220

Lublin, Lublin Voivodeship, Poland

Local Institution - 0231

Gdynia, Pomeranian Voivodeship, Poland

Local Institution - 0219

Bydgoszcz, Poland

Local Institution - 0120

Bucharest, București, Romania

Local Institution - 0123

Bucharest, București, Romania

Local Institution - 0132

Florești, Cluj, Romania

Local Institution - 0130

Craiova, Dolj, Romania

Local Institution - 0115

Bucharest, Romania

Local Institution - 0133

Cluj-Napoca, Romania

Local Institution - 0124

Iași, Romania

Local Institution - 0119

Iași, Romania

Local Institution - 0263

Singapore, Singapore

Local Institution - 0262

Singapore, Singapore

Local Institution - 0089

Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea

Local Institution - 0043

Goyang-si, Kyǒnggi-do, South Korea

Local Institution - 0044

Seongnam, Kyǒnggi-do, South Korea

Local Institution - 0046

Suwon, Kyǒnggi-do, South Korea

Local Institution - 0095

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0045

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0092

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0042

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0218

Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0177

Barcelona, Catalunya [Cataluña], Spain

Local Institution - 0175

Madrid, Madrid, Comunidad de, Spain

Local Institution - 0206

Madrid, Madrid, Comunidad de, Spain

Local Institution - 0176

Madrid, Madrid, Comunidad de, Spain

Local Institution - 0181

Majadahonda, Madrid, Comunidad de, Spain

Local Institution - 0178

Málaga, Spain

Local Institution - 0182

Seville, Spain

Local Institution - 0180

Valencia, Spain

Local Institution - 0179

Zaragoza, Spain

Kantonsspital Baden

Baden, Canton of Aargau, Switzerland

Cantonal Hospital St.Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Local Institution - 0189

Bellinzona, Switzerland

Local Institution - 0053

Kaohsiung City, Taiwan

Local Institution - 0050

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Local Institution - 0265

Bangkok, Bangkok, Thailand

Local Institution - 0272

Mueng, Changwat Khon Kaen, Thailand

Local Institution - 0264

Bangkok, Thailand

Local Institution - 0266

Songkhla, Thailand

Local Institution - 0110

Glasgow, Glasgow City, United Kingdom

Local Institution - 0061

London, Kensington and Chelsea, United Kingdom

Local Institution - 0140

London, London, City of, United Kingdom

Local Institution - 0281

Sulton, Surrey, United Kingdom

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NCT07100080