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)

November 9, 2026 updated by: Bristol-Myers Squibb

A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
850

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1122AAL
        • Not yet recruiting
        • Local Institution - 0086
        • Contact:
          • Site 0086
      • Buenos Aires, Argentina, C1199ABB
        • Not yet recruiting
        • Local Institution - 0432
        • Contact:
          • Site 0432
      • Buenos Aires, Argentina, C1280AEB
        • Not yet recruiting
        • Local Institution - 0085
        • Contact:
          • Site 0085
      • Buenos Aires, Argentina, C1426AGE
        • Not yet recruiting
        • Local Institution - 0078
        • Contact:
          • Site 0078
      • Buenos Aires, Argentina, C1426ANZ
        • Not yet recruiting
        • Local Institution - 0151
        • Contact:
          • Site 0151
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, B7602CBM
        • Not yet recruiting
        • Local Institution - 0077
        • Contact:
          • Site 0077
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Not yet recruiting
        • Local Institution - 0514
        • Contact:
          • Site 0514
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Not yet recruiting
        • Local Institution - 0424
        • Contact:
          • Site 0424
      • Westmead, New South Wales, Australia, 2145
        • Not yet recruiting
        • Local Institution - 0439
        • Contact:
          • Site 0439
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Not yet recruiting
        • Local Institution - 0511
        • Contact:
          • Site 0511
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Not yet recruiting
        • Local Institution - 0492
        • Contact:
          • Site 0492
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Not yet recruiting
        • Local Institution - 0447
        • Contact:
          • Site 0447
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Not yet recruiting
        • Local Institution - 0437
        • Contact:
          • Site 0437
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Not yet recruiting
        • Local Institution - 0255
        • Contact:
          • Site 0255
      • São Paulo, Brazil, 01246-000
        • Not yet recruiting
        • Local Institution - 0259
        • Contact:
          • Site 0259
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29043-260
        • Not yet recruiting
        • Local Institution - 0253
        • Contact:
          • Site 0253
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40170-110
        • Not yet recruiting
        • Local Institution - 0291
        • Contact:
          • Site 0291
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Not yet recruiting
        • Local Institution - 0247
        • Contact:
          • Site 0247
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88020
        • Not yet recruiting
        • Local Institution - 0252
        • Contact:
          • Site 0252
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Not yet recruiting
        • Local Institution - 0244
        • Contact:
          • Site 0244
      • Campinas, São Paulo, Brazil, 13060-803
        • Not yet recruiting
        • Local Institution - 0249
        • Contact:
          • Site 0249
      • Sorocaba, São Paulo, Brazil, 18030-005
        • Not yet recruiting
        • Local Institution - 0261
        • Contact:
          • Site 0261
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G1Z2
        • Not yet recruiting
        • Local Institution - 0059
        • Contact:
          • Site 0059
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z4E6
        • Not yet recruiting
        • Local Institution - 0056
        • Contact:
          • Site 0056
    • Quebec
      • Montreal, Quebec, Canada, H3T1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
          • Jennifer Friedmann, Site 0058
          • Phone Number: 514340822224915
      • Montreal, Quebec, Canada, H4A3J1
        • Not yet recruiting
        • Local Institution - 0057
        • Contact:
          • Site 0057
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T1A5
        • Not yet recruiting
        • Local Institution - 0040
        • Contact:
          • Site 0040
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Not yet recruiting
        • Local Institution - 0517
        • Contact:
          • Site 0517
      • Beijing, Beijing Municipality, China, 101149
        • Not yet recruiting
        • Local Institution - 0458
        • Contact:
          • Site 0458
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Not yet recruiting
        • Local Institution - 0535
        • Contact:
          • Site 0535
      • Chongqing, Chongqing Municipality, China, 400030
        • Not yet recruiting
        • Local Institution - 0470
        • Contact:
          • Site 0470
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Not yet recruiting
        • Local Institution - 0493
        • Contact:
          • Site 0493
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Local Institution - 0457
        • Contact:
          • Site 0457
    • Guangdong
      • Dongguan Shi, Guangdong, China, 523059
        • Not yet recruiting
        • Local Institution - 0326
        • Contact:
          • Site 0326
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Local Institution - 0331
        • Contact:
          • Site 0331
      • Jiangmen, Guangdong, China, 529000
        • Not yet recruiting
        • Local Institution - 0512
        • Contact:
          • Site 0512
      • Zhongshan, Guangdong, China, 528403
        • Not yet recruiting
        • Local Institution - 0478
        • Contact:
          • Site 0478
    • Guangxi
      • Guilin, Guangxi, China, 541199
        • Not yet recruiting
        • Local Institution - 0321
        • Contact:
          • Site 0321
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • Local Institution - 0328
        • Contact:
          • Site 0328
    • Guizhou
      • Guiyang, Guizhou, China, 550003
        • Not yet recruiting
        • Local Institution - 0505
        • Contact:
          • Site 0505
    • Hainan
      • Haikou, Hainan, China, 570000
        • Not yet recruiting
        • Local Institution - 0330
        • Contact:
          • Site 0330
    • Hebei
      • Shijiazhuang, Hebei, China, 050035
        • Not yet recruiting
        • Local Institution - 0322
        • Contact:
          • Site 0322
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Local Institution - 0343
        • Contact:
          • Site 0343
    • Henan
      • Anyang, Henan, China, 455000
        • Not yet recruiting
        • Local Institution - 0298
        • Contact:
          • Site 0298
      • Weihui Shi, Henan, China, 453100
        • Not yet recruiting
        • Local Institution - 0341
        • Contact:
          • Site 0341
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Local Institution - 0480
        • Contact:
          • Site 0480
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Local Institution - 0423
        • Contact:
          • Site 0423
    • Hubei
      • Jingzhou, Hubei, China
        • Not yet recruiting
        • Local Institution - 0483
        • Contact:
          • Site 0483
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Local Institution - 0450
        • Contact:
          • Site 0450
    • Hunan
      • Changsha, Hunan, China, 410007
        • Not yet recruiting
        • Local Institution - 0482
        • Contact:
          • Site 0482
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Local Institution - 0467
        • Contact:
          • Site 0467
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • Local Institution - 0536
        • Contact:
          • Site 0536
      • Changsha Shi, Hunan, China, 410013
        • Not yet recruiting
        • Local Institution - 0306
        • Contact:
          • Site 0306
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222061
        • Not yet recruiting
        • Local Institution - 0531
        • Contact:
          • Site 0531
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • Local Institution - 0347
        • Contact:
          • Site 0347
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Not yet recruiting
        • Local Institution - 0332
        • Contact:
          • Site 0332
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Withdrawn
        • Local Institution - 0464
    • Shandong
      • Binzhou, Shandong, China, 256603
        • Not yet recruiting
        • Local Institution - 0479
        • Contact:
          • Site 0479
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Local Institution - 0455
        • Contact:
          • Site 0455
      • Linyi, Shandong, China, 276027
        • Not yet recruiting
        • Local Institution - 0413
        • Contact:
          • Site 0413
      • Weifang Shi, Shandong, China, 261000
        • Not yet recruiting
        • Local Institution - 0469
        • Contact:
          • Site 0469
    • Shanghai Municipality
      • Shanghai Shi, Shanghai Municipality, China, 200120
        • Not yet recruiting
        • Local Institution - 0319
        • Contact:
          • Site 0319
    • Shanxi
      • Taiyuan, Shanxi, China, 30001
        • Not yet recruiting
        • Local Institution - 0316
        • Contact:
          • Site 0316
      • Taiyuan, Shanxi, China, 30013
        • Not yet recruiting
        • Local Institution - 0463
        • Contact:
          • Site 0463
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Local Institution - 0456
        • Contact:
          • Site 0456
      • Chengdu, Sichuan, China, 610041
        • Withdrawn
        • Local Institution - 0471
      • Chengdu, Sichuan, China, 610066
        • Not yet recruiting
        • Local Institution - 0534
        • Contact:
          • Site 0534
      • Dazhou Shi, Sichuan, China, 635000
        • Not yet recruiting
        • Local Institution - 0320
        • Contact:
          • Site 0320
      • Yibin, Sichuan, China, 644000
        • Not yet recruiting
        • Local Institution - 0472
        • Contact:
          • Site 0472
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Not yet recruiting
        • Local Institution - 0452
        • Contact:
          • Site 0452
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Local Institution - 0312
        • Contact:
          • Site 0312
  • France
      • Brest, France, 29200
        • Not yet recruiting
        • Local Institution - 0073
        • Contact:
          • Site 0073
      • Caen, France, 14076
        • Not yet recruiting
        • Local Institution - 0066
        • Contact:
          • Site 0066
      • Toulouse, France, 31059
        • Not yet recruiting
        • Local Institution - 0070
        • Contact:
          • Site 0070
    • Bouches-Du-Rhône
      • Marseille, Bouches-Du-Rhône, France, 13915
        • Not yet recruiting
        • Local Institution - 0074
        • Contact:
          • Site 0074
    • Côte-D'Or
      • Dijon, Côte-D'Or, France, 21079
        • Not yet recruiting
        • Local Institution - 0063
        • Contact:
          • Site 0063
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44093
        • Not yet recruiting
        • Local Institution - 0075
        • Contact:
          • Site 0075
    • Nan
      • La Tronche, Nan, France, 38700
        • Not yet recruiting
        • Local Institution - 0064
        • Contact:
          • Site 0064
      • Lyon, Nan, France, 69373
        • Not yet recruiting
        • Local Institution - 0116
        • Contact:
          • Site 0116
      • Paris, Nan, France, 75014
        • Not yet recruiting
        • Local Institution - 0109
        • Contact:
          • Site 0109
    • Rhône
      • Bron, Rhône, France, 69677
        • Not yet recruiting
        • Local Institution - 0062
        • Contact:
          • Site 0062
    • Val-De-Marne
      • Villejuif, Val-De-Marne, France, 94805
        • Not yet recruiting
        • Local Institution - 0069
        • Contact:
          • Site 0069
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75248
        • Not yet recruiting
        • Local Institution - 0071
        • Contact:
          • Site 0071
  • Germany
      • Giessen, Germany, 35392
        • Not yet recruiting
        • Local Institution - 0445
        • Contact:
          • Site 0445
    • Baden-Wurttemberg
      • Gerlingen, Baden-Wurttemberg, Germany, 70839
        • Not yet recruiting
        • Local Institution - 0112
        • Contact:
          • Site 0112
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Not yet recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001
      • Regensburg, Bavaria, Germany, 93053
        • Not yet recruiting
        • Local Institution - 0105
        • Contact:
          • Site 0105
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60389
        • Not yet recruiting
        • Local Institution - 0446
        • Contact:
          • Site 0446
    • Lower Saxony
      • Oldenburg, Lower Saxony, Germany, 26121
        • Not yet recruiting
        • Local Institution - 0106
        • Contact:
          • Site 0106
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Not yet recruiting
        • Local Institution - 0100
        • Contact:
          • Site 0100
      • Dortmund, North Rhine-Westphalia, Germany, 44263
        • Not yet recruiting
        • Local Institution - 0243
        • Contact:
          • Site 0243
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Not yet recruiting
        • Local Institution - 0104
        • Contact:
          • Site 0104
      • Hemer, North Rhine-Westphalia, Germany, 58675
        • Not yet recruiting
        • Local Institution - 0117
        • Contact:
          • Site 0117
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Not yet recruiting
        • Local Institution - 0101
        • Contact:
          • Site 0101
    • Saxony
      • Dresden, Saxony, Germany, 1307
        • Not yet recruiting
        • Local Institution - 0103
        • Contact:
          • Site 0103
      • Leipzig, Saxony, Germany, 4103
        • Not yet recruiting
        • Local Institution - 0412
        • Contact:
          • Site 0412
    • Schleswig-Holstein
      • Großhansdorf, Schleswig-Holstein, Germany, 22927
        • Not yet recruiting
        • Local Institution - 0108
        • Contact:
          • Site 0108
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Not yet recruiting
        • Local Institution - 0239
        • Contact:
          • Site 0239
  • India
    • Gujarat
      • Vadodara, Gujarat, India, 361790
        • Not yet recruiting
        • Local Institution - 0225
        • Contact:
          • Site 0225
    • Haryana
      • Badsa, Haryana, India, 124105
        • Not yet recruiting
        • Local Institution - 0444
        • Contact:
          • Site 0444
      • Gurgaon, Haryana, India, 122001
        • Not yet recruiting
        • Local Institution - 0337
        • Contact:
          • Site 0337
    • Karnataka
      • Belagavi, Karnataka, India, 590010
        • Not yet recruiting
        • Local Institution - 0436
        • Contact:
          • Site 0436
    • Maharashtra
      • Pune, Maharashtra, India, 411013
        • Not yet recruiting
        • Local Institution - 0215
        • Contact:
          • Site 0215
    • Punjab
      • Mohali, Punjab, India, 140901
        • Not yet recruiting
        • Local Institution - 0233
        • Contact:
          • Site 0233
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600035
        • Not yet recruiting
        • Local Institution - 0222
        • Contact:
          • Site 0222
  • Italy
      • Brescia, Italy, 25123
        • Not yet recruiting
        • Local Institution - 0289
        • Contact:
          • Site 0289
      • Milan, Italy, 20133
        • Not yet recruiting
        • Local Institution - 0089
        • Contact:
          • Site 0089
      • Milan, Italy, 20141
        • Not yet recruiting
        • Local Institution - 0087
        • Contact:
          • Site 0087
      • Milan, Italy, 20142
        • Not yet recruiting
        • Local Institution - 0238
        • Contact:
          • Site 0238
      • Pavia, Italy, 27100
        • Not yet recruiting
        • Local Institution - 0091
        • Contact:
          • Site 0091
      • Verona, Italy, 37126
        • Not yet recruiting
        • Local Institution - 0088
        • Contact:
          • Site 0088
    • BG
      • Bergamo, BG, Italy, 24127
        • Not yet recruiting
        • Local Institution - 0093
        • Contact:
          • Site 0093
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italy, 47014
        • Not yet recruiting
        • Local Institution - 0236
        • Contact:
          • Site 0236
    • Turin
      • Candiolo, Turin, Italy, 10060
        • Not yet recruiting
        • Local Institution - 0094
        • Contact:
          • Site 0094
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Not yet recruiting
        • Local Institution - 0262
        • Contact:
          • Site 0262
    • Ehime
      • Toon-Shi, Ehime, Japan, 791-0295
        • Not yet recruiting
        • Local Institution - 0128
        • Contact:
          • Site 0128
    • Fukuoka
      • Kurume-Shi, Fukuoka, Japan, 830-0011
        • Not yet recruiting
        • Local Institution - 0136
        • Contact:
          • Site 0136
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Not yet recruiting
        • Local Institution - 0121
        • Contact:
          • Site 0121
    • Miyagi
      • Sendai, Miyagi, Japan, 980-0873
        • Not yet recruiting
        • Local Institution - 0122
        • Contact:
          • Site 0122
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Not yet recruiting
        • Local Institution - 0433
        • Contact:
          • Site 0433
    • Osaka
      • Hirakata-Shi, Osaka, Japan, 573-1191
        • Not yet recruiting
        • Local Institution - 0125
        • Contact:
          • Site 0125
      • Osakasayama-Shi, Osaka, Japan, 589-8511
        • Not yet recruiting
        • Local Institution - 0129
        • Contact:
          • Site 0129
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Not yet recruiting
        • Local Institution - 0141
        • Contact:
          • Site 0141
    • Tokyo-To
      • Chūōku, Tokyo-To, Japan, 104-0045
        • Not yet recruiting
        • Local Institution - 0137
        • Contact:
          • Site 0137
      • Kōtoku, Tokyo-To, Japan, 135-8550
        • Not yet recruiting
        • Local Institution - 0414
        • Contact:
          • Site 0414
  • South Korea
      • Gyeongsangnam-do, South Korea, 050612
        • Not yet recruiting
        • Local Institution - 0139
        • Contact:
          • Site 0139
      • Seoul, South Korea, 120-752
        • Not yet recruiting
        • Local Institution - 0135
        • Contact:
          • Site 0135
      • Seoul, South Korea, 8308
        • Not yet recruiting
        • Local Institution - 0126
        • Contact:
          • Site 0126
    • Chungcheongbuk-do [Chungbuk]
      • Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea, 28644
        • Not yet recruiting
        • Local Institution - 0140
        • Contact:
          • Site 0140
    • Daegu
      • Buk-Gu, Daegu, South Korea, 41404
        • Not yet recruiting
        • Local Institution - 0138
        • Contact:
          • Site 0138
      • Dalseo, Daegu, South Korea, 42601
        • Not yet recruiting
        • Local Institution - 0506
        • Contact:
          • Site 0506
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 410-769
        • Not yet recruiting
        • Local Institution - 0127
        • Contact:
          • Site 0127
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Not yet recruiting
        • Local Institution - 0133
        • Contact:
          • Site 0133
    • Jeollanam-do
      • Hwasun-Gun, Jeollanam-do, South Korea, 58128
        • Not yet recruiting
        • Local Institution - 0134
        • Contact:
          • Site 0134
    • Seoul
      • Seocho -Gu, Seoul, South Korea, 6591
        • Not yet recruiting
        • Local Institution - 0124
        • Contact:
          • Site 0124
      • Songpa-Gu, Seoul, South Korea, 138-736
        • Not yet recruiting
        • Local Institution - 0123
        • Contact:
          • Site 0123
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
        • Not yet recruiting
        • Local Institution - 0131
        • Contact:
          • Site 0131
  • Spain
      • A Coruña, Spain, 15006
        • Not yet recruiting
        • Local Institution - 0242
        • Contact:
          • Site 0242
      • Jaén, Spain, 23007
        • Not yet recruiting
        • Local Institution - 0144
        • Contact:
          • Site 0144
      • Jaén, Spain, 23007
        • Withdrawn
        • Local Institution - 0226
      • Jerez de la Frontera, Spain, 11407
        • Not yet recruiting
        • Local Institution - 0149
        • Contact:
          • Site 0149
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Local Institution - 0148
        • Contact:
          • Site 0148
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Local Institution - 0150
        • Contact:
          • Site 0150
      • Valencia, Spain, 46009
        • Not yet recruiting
        • Local Institution - 0241
        • Contact:
          • Site 0241
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Not yet recruiting
        • Local Institution - 0143
        • Contact:
          • Site 0143
    • Seville
      • Seville, Seville, Spain, 41013
        • Not yet recruiting
        • Local Institution - 0147
        • Contact:
          • Site 0147
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
          • Jen-Yu Hung, Site 0227
          • Phone Number: +888-7-3121101-5651
      • Taichung, Taiwan, 404332
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Chih-Yen Tu, Site 0216
          • Phone Number: 886-4-22052121ext.12
      • Taichung, Taiwan, 402
        • Not yet recruiting
        • Local Institution - 0418
        • Contact:
          • Site 0418
      • Tainan, Taiwan, 70428
        • Not yet recruiting
        • Local Institution - 0420
        • Contact:
          • Site 0420
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Taiwan, 82445
        • Not yet recruiting
        • Local Institution - 0229
        • Contact:
          • Site 0229
    • New Taipei
      • New Taipei City, New Taipei, Taiwan, 23561
        • Not yet recruiting
        • Local Institution - 0230
        • Contact:
          • Site 0230
    • Taipei
      • Taipei City, Taipei, Taiwan, 106
        • Not yet recruiting
        • Local Institution - 0223
        • Contact:
          • Site 0223
    • Taoyuan
      • Taoyuan City, Taoyuan, Taiwan, 33378
        • Not yet recruiting
        • Local Institution - 0221
        • Contact:
          • Site 0221
  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10300
        • Not yet recruiting
        • Local Institution - 0275
        • Contact:
          • Site 0275
      • Din Daeng, Bangkok, Thailand, 10400
        • Not yet recruiting
        • Local Institution - 0263
        • Contact:
          • Site 0263
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 1060
        • Not yet recruiting
        • Local Institution - 0014
        • Contact:
          • Site 0014
      • Adana, Turkey (Türkiye), 1370
        • Not yet recruiting
        • Local Institution - 0019
        • Contact:
          • Site 0019
      • Ankara, Turkey (Türkiye), 6680
        • Not yet recruiting
        • Local Institution - 0008
        • Contact:
          • Site 0008
      • Ankara, Turkey (Türkiye), 6800
        • Not yet recruiting
        • Local Institution - 0003
        • Contact:
          • Site 0003
      • Antalya, Turkey (Türkiye), 07100
        • Not yet recruiting
        • Local Institution - 0015
        • Contact:
          • Site 0015
      • Istanbul, Turkey (Türkiye), 34214
        • Not yet recruiting
        • Local Institution - 0041
        • Contact:
          • Site 0041
      • Istanbul, Turkey (Türkiye), 34295
        • Not yet recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
      • Izmir, Turkey (Türkiye), 35110
        • Not yet recruiting
        • Local Institution - 0050
        • Contact:
          • Site 0050
      • Izmir, Turkey (Türkiye), 35530
        • Not yet recruiting
        • Local Institution - 0037
        • Contact:
          • Site 0037
    • Diyarbakır
      • Sur, Diyarbakır, Turkey (Türkiye), 21200
        • Not yet recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
    • Istanbul
      • Pendik, Istanbul, Turkey (Türkiye), 34340
        • Not yet recruiting
        • Local Institution - 0265
        • Contact:
          • Site 0265
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Not yet recruiting
        • Local Institution - 0212
        • Contact:
          • Site 0212
      • Fullerton, California, United States, 92835
        • Not yet recruiting
        • Local Institution - 0504
        • Contact:
          • Site 0504
      • La Jolla, California, United States, 92093
        • Not yet recruiting
        • Local Institution - 0357
        • Contact:
          • Site 0357
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Recruiting
        • Rocky Mountain Cancer Centers
        • Contact:
          • Hossein Maymani, Site 0520
          • Phone Number: 000-000-0000
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Not yet recruiting
        • Local Institution - 0161
        • Contact:
          • Site 0161
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Not yet recruiting
        • Local Institution - 0527
        • Contact:
          • Site 0527
      • Orlando, Florida, United States, 32806
        • Not yet recruiting
        • Local Institution - 0366
        • Contact:
          • Site 0366
      • Palm Bay, Florida, United States, 32901
        • Recruiting
        • Cancer Care Centers of Brevard - Rockledge
        • Contact:
          • Venkat Pavan Kancharla, Site 0519
          • Phone Number: 111-111-1111
      • St. Petersburg, Florida, United States, 33701
        • Not yet recruiting
        • Local Institution - 0526
        • Contact:
          • Site 0526
      • West Palm Beach, Florida, United States, 33401
        • Not yet recruiting
        • Local Institution - 0524
        • Contact:
          • Site 0524
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Local Institution - 0185
        • Contact:
          • Site 0185
      • Ottawa, Illinois, United States, 61350
        • Not yet recruiting
        • Local Institution - 0207
        • Contact:
          • Site 0207
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Not yet recruiting
        • Local Institution - 0503
        • Contact:
          • Site 0503
      • Baltimore, Maryland, United States, 21231
        • Not yet recruiting
        • Local Institution - 0537
        • Contact:
          • Site 0537
      • Silver Spring, Maryland, United States, 20904
        • Not yet recruiting
        • Local Institution - 0523
        • Contact:
          • Site 0523
    • Minnesota
      • Edina, Minnesota, United States, 55435-2150
        • Not yet recruiting
        • Local Institution - 0521
        • Contact:
          • Site 0521
      • Saint Paul, Minnesota, United States, 55102
        • Not yet recruiting
        • Local Institution - 0364
        • Contact:
          • Site 0364
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School Of Medicine
        • Contact:
          • Christine Auberle, Site 0403
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Not yet recruiting
        • Local Institution - 0402
        • Contact:
          • Site 0402
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Not yet recruiting
        • Local Institution - 0290
        • Contact:
          • Site 0290
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Not yet recruiting
        • Local Institution - 0183
        • Contact:
          • Site 0183
    • New York
      • New York, New York, United States, 10021
        • Not yet recruiting
        • Local Institution - 0153
        • Contact:
          • Site 0153
      • The Bronx, New York, United States, 10461
        • Not yet recruiting
        • Local Institution - 0157
        • Contact:
          • Site 0157
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Not yet recruiting
        • Local Institution - 0385
        • Contact:
          • Site 0385
    • Ohio
      • Sandusky, Ohio, United States, 44870
        • Not yet recruiting
        • Local Institution - 0438
        • Contact:
          • Site 0438
    • Oregon
      • Portland, Oregon, United States, 97213
        • Not yet recruiting
        • Local Institution - 0404
        • Contact:
          • Site 0404
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • Not yet recruiting
        • Local Institution - 0487
        • Contact:
          • Site 0487
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Not yet recruiting
        • Local Institution - 0200
        • Contact:
          • Site 0200
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Not yet recruiting
        • Local Institution - 0199
        • Contact:
          • Site 0199
    • Texas
      • Beaumont, Texas, United States, 77702
        • Recruiting
        • Texas Oncology
        • Contact:
          • Ashok Malani, Site 0522
          • Phone Number: 713-792-2740
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - DFW
        • Contact:
          • Kartik Konduri, Site 0525
          • Phone Number: 214-370-1000
      • San Antonio, Texas, United States, 78217
        • Recruiting
        • Texas Oncology - San Antonio
        • Contact:
          • Krishna Alluri, Site 0529
          • Phone Number: 210-656-7177
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Not yet recruiting
        • Local Institution - 0411
        • Contact:
          • Site 0411
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Not yet recruiting
        • Local Institution - 0165
        • Contact:
          • Site 0165
      • Fairfax, Virginia, United States, 22031
        • Not yet recruiting
        • Local Institution - 0530
        • Contact:
          • Site 0530
      • Winchester, Virginia, United States, 22601
        • Recruiting
        • Shenandoah Oncology, P.C. (Shenandoah Oncology Associates, P.C.)
        • Contact:
          • Michael McCusker Jr., Site 0528
    • Washington
      • Seattle, Washington, United States, 98104
        • Not yet recruiting
        • Local Institution - 0283
        • Contact:
          • Site 0283
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Not yet recruiting
        • Local Institution - 0502
        • Contact:
          • Site 0502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
Drug: Iza-bren

Specified dose on specified days

Other Names:
  • BMS-986507
  • BL-B01D1
  • Izalontamab brengitecan
Drug: Osimertinib

Specified dose on days
Active Comparator: Arm B
Drug: Carboplatin

Specified dose on specified days

Drug: Pemetrexed

Specified dose on specified days

Drug: Cisplatin

Specified dose on specified days

Drug: Osimertinib

Specified dose on days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Time Frame: Up to approximately 3 years
Up to approximately 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
PFS assessed by the investigator as per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Second Progression-Free Survival (PFS2) as assessed by the Investigator
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Objective Response Rate (ORR) assessed by the BICR as per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Objective Response Rate (ORR) assessed by the investigator as per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Disease Control Rate (DCR) assessed by the BICR as per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Disease Control Rate (DCR) assessed by the investigator as per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Duration of Response (DOR) assessed by the BICR as per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Duration of Response (DOR) assessed by the investigator as per RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA244-0020
  • 2026-526486-21 (Other Identifier: EU CTR)
  • U1111-1338-8955 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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