Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)

NCT07680790 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CA244-00202026-526486-21U1111-1338-8955
• Study Type: interventional
• Target: 850
• Locations: 15 countries
• Sites: 200

Brief Summary

The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC; EGFR; First line; Izalontamab brengitecan; Osimertinib; ADC; IZABRIGHT-Lung02

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

  Up to approximately 3 years

Secondary Outcomes (9)

• Overall Survival (OS)

  Up to approximately 5 years

• PFS assessed by the investigator as per RECIST v1.1

  Up to approximately 3 years

• Second Progression-Free Survival (PFS2) as assessed by the Investigator

  Up to approximately 5 years

• Objective Response Rate (ORR) assessed by the BICR as per RECIST v1.1

  Up to approximately 3 years

• Objective Response Rate (ORR) assessed by the investigator as per RECIST v1.1

  Up to approximately 3 years

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Iza-bren; Drug: Osimertinib

Arm B

ACTIVE COMPARATOR

Drug: Osimertinib; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin

Interventions

Iza-bren DRUG

Specified dose on specified days

Also known as: BMS-986507, BL-B01D1, Izalontamab brengitecan

Arm A

Osimertinib DRUG

Specified dose on days

Arm A; Arm B

Pemetrexed DRUG

Specified dose on specified days

Arm B

Carboplatin DRUG

Specified dose on specified days

Arm B

Cisplatin DRUG

Specified dose on specified days

Arm B

Eligibility Criteria

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

You may qualify if:

• Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment
• Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)
• Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator
• Participants must have ECOG Performance Status 0-1

You may not qualify if:

• Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compression
• Participants must not have history of ILD/pneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD/pneumonitis
• Participants must not have clinically significant cardiac disease

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (200)

Local Institution - 0212

Beverly Hills, California, 90211, United States

Location

Local Institution - 0504

Fullerton, California, 92835, United States

Location

Local Institution - 0357

La Jolla, California, 92093, United States

Location

Local Institution - 0520

Pueblo, Colorado, 81003, United States

Location

Local Institution - 0527

Fort Myers, Florida, 33901, United States

Location

Local Institution - 0366

Orlando, Florida, 32806, United States

Location

Local Institution - 0519

Palm Bay, Florida, 32901, United States

Location

Local Institution - 0210

Honolulu, Hawaii, 96813, United States

Location

Local Institution - 0207

Ottawa, Illinois, 61350, United States

Location

Local Institution - 0503

Baltimore, Maryland, 21202, United States

Location

Local Institution - 0523

Silver Spring, Maryland, 20904, United States

Location

Local Institution - 0521

Edina, Minnesota, 55435, United States

Location

Local Institution - 0364

Saint Paul, Minnesota, 55102, United States

Location

Local Institution - 0403

St Louis, Missouri, 63110, United States

Location

Local Institution - 0402

Omaha, Nebraska, 68198, United States

Location

Local Institution - 0290

Lebanon, New Hampshire, 03756, United States

Location

Local Institution - 0183

New Brunswick, New Jersey, 08901, United States

Location

Local Institution - 0153

New York, New York, 10021, United States

Location

Local Institution - 0157

The Bronx, New York, 10461, United States

Location

Local Institution - 0385

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0438

Sandusky, Ohio, 44870, United States

Location

Local Institution - 0404

Portland, Oregon, 97213, United States

Location

Local Institution - 0487

Easton, Pennsylvania, 18045, United States

Location

Local Institution - 0200

Sioux Falls, South Dakota, 57105, United States

Location

Local Institution - 0199

Memphis, Tennessee, 38120, United States

Location

Local Institution - 0522

Beaumont, Texas, 77702, United States

Location

Local Institution - 0525

Dallas, Texas, 75246, United States

Location

Local Institution - 0529

San Antonio, Texas, 78217, United States

Location

Local Institution - 0411

Salt Lake City, Utah, 84112, United States

Location

Local Institution - 0165

Fairfax, Virginia, 22031, United States

Location

Local Institution - 0530

Fairfax, Virginia, 22031, United States

Location

Local Institution - 0528

Winchester, Virginia, 22601, United States

Location

Local Institution - 0283

Seattle, Washington, 98104, United States

Location

Local Institution - 0502

Morgantown, West Virginia, 26505, United States

Location

Local Institution - 0077

Mar del Plata, Buenos Aires, B7602CBM, Argentina

Location

Local Institution - 0514

Río Cuarto, Córdoba Province, 5800, Argentina

Location

Local Institution - 0086

Buenos Aires, C1122AAL, Argentina

Location

Local Institution - 0432

Buenos Aires, C1199ABB, Argentina

Location

Local Institution - 0085

Buenos Aires, C1280AEB, Argentina

Location

Local Institution - 0078

Buenos Aires, C1426AGE, Argentina

Location

Local Institution - 0151

Buenos Aires, C1426ANZ, Argentina

Location

Local Institution - 0424

Camperdown, New South Wales, 2050, Australia

Location

Local Institution - 0439

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0511

Greenslopes, Queensland, 4120, Australia

Location

Local Institution - 0492

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0447

Clayton, Victoria, 3168, Australia

Location

Local Institution - 0437

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0253

Vitória, Espírito Santo, 29043-260, Brazil

Location

Local Institution - 0291

Salvador, Estado de Bahia, 40170-110, Brazil

Location

Local Institution - 0247

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Local Institution - 0252

Florianópolis, Santa Catarina, 88020, Brazil

Location

Local Institution - 0244

Barretos, São Paulo, 14784-400, Brazil

Location

Local Institution - 0249

Campinas, São Paulo, 13060-803, Brazil

Location

Local Institution - 0261

Sorocaba, São Paulo, 18030-005, Brazil

Location

Local Institution - 0255

Rio de Janeiro, 20230-130, Brazil

Location

Local Institution - 0259

São Paulo, 01246-000, Brazil

Location

Local Institution - 0059

Edmonton, Alberta, T6G1Z2, Canada

Location

Local Institution - 0494

Abbotsford British Columbia, British Columbia, V2S0C2, Canada

Location

Local Institution - 0056

Vancouver, British Columbia, V5Z4E6, Canada

Location

Local Institution - 0533

Oakville, Ontario, L6M 0L8, Canada

Location

Local Institution - 0043

Oshawa, Ontario, L1G2B9, Canada

Location

Local Institution - 0012

Toronto, Ontario, M4N3M5, Canada

Location

Local Institution - 0045

Toronto, Ontario, M5G2M9, Canada

Location

Local Institution - 0407

Laval, Quebec, H7M3L9, Canada

Location

Local Institution - 0058

Montreal, Quebec, H3T1E2, Canada

Location

Local Institution - 0057

Montreal, Quebec, H4A3J1, Canada

Location

Local Institution - 0040

Regina, Saskatchewan, S4T1A5, Canada

Location

Local Institution - 0517

Beijing, Beijing Municipality, 100142, China

Location

Local Institution - 0458

Beijing, Beijing Municipality, 101149, China

Location

Local Institution - 0470

Chongqing, Chongqing Municipality, 400030, China

Location

Local Institution - 0493

Fuzhou, Fujian, 350001, China

Location

Local Institution - 0457

Fuzhou, Fujian, 350014, China

Location

Local Institution - 0326

Dongguan Shi, Guangdong, 523059, China

Location

Local Institution - 0331

Guangzhou, Guangdong, 510080, China

Location

Local Institution - 0478

Zhongshan, Guangdong, 528403, China

Location

Local Institution - 0321

Guilin, Guangxi, 541199, China

Location

Local Institution - 0328

Nanning, Guangxi, 530021, China

Location

Local Institution - 0330

Haikou, Hainan, 570000, China

Location

Local Institution - 0343

Harbin, Heilongjiang, 150081, China

Location

Local Institution - 0298

Anyang, Henan, 455000, China

Location

Local Institution - 0341

Weihui Shi, Henan, 453100, China

Location

Local Institution - 0480

Zhengzhou, Henan, 450000, China

Location

Local Institution - 0423

Zhengzhou, Henan, 450008, China

Location

Local Institution - 0483

Jingzhou, Hubei, 0, China

Location

Local Institution - 0450

Wuhan, Hubei, 430022, China

Location

Local Institution - 0482

Changsha, Hunan, 410007, China

Location

Local Institution - 0467

Changsha, Hunan, 410008, China

Location

Local Institution - 0306

Changsha Shi, Hunan, 410013, China

Location

Local Institution - 0347

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 0332

Shenyang, Liaoning, 110042, China

Location

Local Institution - 0464

Xi'an, Shaanxi, 710038, China

Location

Local Institution - 0479

Binzhou, Shandong, 256603, China

Location

Local Institution - 0455

Jinan, Shandong, 250117, China

Location

Local Institution - 0413

Linyi, Shandong, 276027, China

Location

Local Institution - 0469

Weifang Shi, Shandong, 261000, China

Location

Local Institution - 0319

Shanghai Shi, Shanghai Municipality, 200120, China

Location

Local Institution - 0316

Taiyuan, Shanxi, 30001, China

Location

Local Institution - 0463

Taiyuan, Shanxi, 30013, China

Location

Local Institution - 0456

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0471

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0320

Dazhou Shi, Sichuan, 635000, China

Location

Local Institution - 0472

Yibin, Sichuan, 644000, China

Location

Local Institution - 0452

Tianjin, Tianjin Municipality, 300060, China

Location

Local Institution - 0312

Hangzhou, Zhejiang, 310022, China

Location

Local Institution - 0074

Marseille, Bouches-Du-Rhône, 13915, France

Location

Local Institution - 0063

Dijon, Côte-D'Or, 21079, France

Location

Local Institution - 0075

Nantes, Loire Atlantique, 44093, France

Location

Local Institution - 0064

La Tronche, Nan, 38700, France

Location

Local Institution - 0116

Lyon, Nan, 69373, France

Location

Local Institution - 0109

Paris, Nan, 75014, France

Location

Local Institution - 0062

Bron, Rhône, 69677, France

Location

Local Institution - 0069

Villejuif, Val-De-Marne, 94805, France

Location

Local Institution - 0073

Brest, 29200, France

Location

Local Institution - 0066

Caen, 14076, France

Location

Local Institution - 0070

Toulouse, 31059, France

Location

Local Institution - 0071

Paris, Île-de-France Region, 75248, France

Location

Local Institution - 0112

Gerlingen, Baden-Wurttemberg, 70839, Germany

Location

Local Institution - 0111

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Local Institution - 0110

Wangen, Baden-Wurttemberg, 88239, Germany

Location

Local Institution - 0001

Munich, Bavaria, 81377, Germany

Location

Local Institution - 0105

Regensburg, Bavaria, 93053, Germany

Location

Local Institution - 0446

Frankfurt am Main, Hesse, 60389, Germany

Location

Local Institution - 0106

Oldenburg, Lower Saxony, 26121, Germany

Location

Local Institution - 0100

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Local Institution - 0243

Dortmund, North Rhine-Westphalia, 44263, Germany

Location

Local Institution - 0104

Essen, North Rhine-Westphalia, 45147, Germany

Location

Local Institution - 0117

Hemer, North Rhine-Westphalia, 58675, Germany

Location

Local Institution - 0101

Münster, North Rhine-Westphalia, 48149, Germany

Location

Local Institution - 0103

Dresden, Saxony, 1307, Germany

Location

Local Institution - 0412

Leipzig, Saxony, 4103, Germany

Location

Local Institution - 0108

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

Local Institution - 0239

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Local Institution - 0445

Giessen, 35392, Germany

Location

Local Institution - 0225

Vadodara, Gujarat, 361790, India

Location

Local Institution - 0444

Badsa, Haryana, 124105, India

Location

Local Institution - 0337

Gurgaon, Haryana, 122001, India

Location

Local Institution - 0436

Belagavi, Karnataka, 590010, India

Location

Local Institution - 0215

Pune, Maharashtra, 411013, India

Location

Local Institution - 0233

Mohali, Punjab, 140901, India

Location

Local Institution - 0222

Chennai, Tamil Nadu, 600035, India

Location

Local Institution - 0236

Meldola, Forli-Cesena, 47014, Italy

Location

Local Institution - 0094

Candiolo, Turin, 10060, Italy

Location

Local Institution - 0093

Bergamo, 24128, Italy

Location

Local Institution - 0289

Brescia, 25123, Italy

Location

Local Institution - 0089

Milan, 20133, Italy

Location

Local Institution - 0087

Milan, 20141, Italy

Location

Local Institution - 0238

Milan, 20142, Italy

Location

Local Institution - 0091

Pavia, 27100, Italy

Location

Local Institution - 0088

Verona, 37126, Italy

Location

Local Institution - 0262

Nagoya, Aichi-ken, 464-8681, Japan

Location

Local Institution - 0128

Toon-Shi, Ehime, 791-0295, Japan

Location

Local Institution - 0136

Kurume-Shi, Fukuoka, 830-0011, Japan

Location

Local Institution - 0121

Yokohama, Kanagawa, 241-8515, Japan

Location

Local Institution - 0122

Sendai, Miyagi, 980-0873, Japan

Location

Local Institution - 0433

Okayama, Okayama-ken, 700-8558, Japan

Location

Local Institution - 0125

Hirakata-Shi, Osaka, 573-1191, Japan

Location

Local Institution - 0129

Osakasayama-Shi, Osaka, 589-8511, Japan

Location

Local Institution - 0141

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Local Institution - 0137

Chūōku, Tokyo-To, 104-0045, Japan

Location

Local Institution - 0414

Kōtoku, Tokyo-To, 135-8550, Japan

Location

Local Institution - 0140

Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, South Korea

Location

Local Institution - 0138

Buk-Gu, Daegu, 41404, South Korea

Location

Local Institution - 0506

Dalseo, Daegu, 42601, South Korea

Location

Local Institution - 0127

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Local Institution - 0133

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Local Institution - 0134

Hwasun-Gun, Jeollanam-do, 58128, South Korea

Location

Local Institution - 0124

Seocho -Gu, Seoul, 6591, South Korea

Location

Local Institution - 0123

Songpa-Gu, Seoul, 138-736, South Korea

Location

Local Institution - 0139

Gyeongsangnam-do, 050612, South Korea

Location

Local Institution - 0135

Seoul, 120-752, South Korea

Location

Local Institution - 0131

Seoul, 3080, South Korea

Location

Local Institution - 0126

Seoul, 8308, South Korea

Location

Local Institution - 0143

Majadahonda, Madrid, 28222, Spain

Location

Local Institution - 0147

Seville, Seville, 41013, Spain

Location

Local Institution - 0242

A Coruña, 15006, Spain

Location

Local Institution - 0144

Jaén, 23007, Spain

Location

Local Institution - 0226

Jaén, 23007, Spain

Location

Local Institution - 0149

Jerez de la Frontera, 11407, Spain

Location

Local Institution - 0148

Madrid, 28041, Spain

Location

Local Institution - 0150

Málaga, 29010, Spain

Location

Local Institution - 0241

Valencia, 46009, Spain

Location

Local Institution - 0229

Kaohsiung City, Kaohsiung, 82445, Taiwan

Location

Local Institution - 0230

New Taipei City, New Taipei, 23561, Taiwan

Location

Local Institution - 0216

Taipei, Taichung, 112, Taiwan

Location

Local Institution - 0227

Gaoxiongka, Taiwan, 807, Taiwan

Location

Local Institution - 0221

Taoyuan City, Taoyuan, 33378, Taiwan

Location

Local Institution - 0418

Taichung, 40201, Taiwan

Location

Local Institution - 0420

Tainan, 70428, Taiwan

Location

Local Institution - 0419

Taipei, 100225, Taiwan

Location

Local Institution - 0021

Sur, Diyarbakır, 21200, Turkey (Türkiye)

Location

Local Institution - 0265

Pendik, Istanbul, 34340, Turkey (Türkiye)

Location

Local Institution - 0014

Adana, 1060, Turkey (Türkiye)

Location

Local Institution - 0019

Adana, 1370, Turkey (Türkiye)

Location

Local Institution - 0008

Ankara, 6680, Turkey (Türkiye)

Location

Local Institution - 0003

Ankara, 6800, Turkey (Türkiye)

Location

Local Institution - 0015

Antalya, 07100, Turkey (Türkiye)

Location

Local Institution - 0041

Istanbul, 34214, Turkey (Türkiye)

Location

Local Institution - 0039

Istanbul, 34295, Turkey (Türkiye)

Location

Local Institution - 0050

Izmir, 35110, Turkey (Türkiye)

Location

Local Institution - 0037

Izmir, 35530, Turkey (Türkiye)

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib; Pemetrexed; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 30, 2031
• Study Completion (Estimated): December 30, 2031
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

DE (17); IN (7); JP (11); IT (9); KR (12); ES (9); TW (8); CA (11); TU (11); US (34); CN (37); AU (6); FR (12); BR (9); AR (7)