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)

June 26, 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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • 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

  • 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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution - 0424
        • Contact:
          • Site 0424
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0439
        • Contact:
          • Site 0439
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Local Institution - 0511
        • Contact:
          • Site 0511
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0492
        • Contact:
          • Site 0492
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Local Institution - 0447
        • Contact:
          • Site 0447
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0437
        • Contact:
          • Site 0437
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G1Z2
        • Local Institution - 0059
        • Contact:
          • Site 0059
    • British Columbia
      • Abbotsford British Columbia, British Columbia, Canada, V2S0C2
        • Local Institution - 0494
      • Vancouver, British Columbia, Canada, V5Z4E6
        • Local Institution - 0056
        • Contact:
          • Site 0056
    • Ontario
      • Oakville, Ontario, Canada, L6M 0L8
        • Local Institution - 0533
        • Contact:
          • Site 0533
      • Oshawa, Ontario, Canada, L1G2B9
        • Local Institution - 0043
        • Contact:
          • Site 0043
      • Toronto, Ontario, Canada, M4N3M5
        • Local Institution - 0012
        • Contact:
          • Site 0012
      • Toronto, Ontario, Canada, M5G2M9
        • Local Institution - 0045
    • Quebec
      • Laval, Quebec, Canada, H7M3L9
        • Local Institution - 0407
      • Montreal, Quebec, Canada, H3T1E2
        • Local Institution - 0058
        • Contact:
          • Site 0058
      • Montreal, Quebec, Canada, H4A3J1
        • Local Institution - 0057
        • Contact:
          • Site 0057
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T1A5
        • Local Institution - 0040
        • Contact:
          • Site 0040
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Local Institution - 0517
        • Contact:
          • Site 0517
      • Beijing, Beijing Municipality, China, 101149
        • Local Institution - 0458
        • Contact:
          • Site 0458
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Local Institution - 0470
        • Contact:
          • Site 0470
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Local Institution - 0493
        • Contact:
          • Site 0493
      • Fuzhou, Fujian, China, 350014
        • Local Institution - 0457
        • Contact:
          • Site 0457
    • Guangdong
      • Dongguan Shi, Guangdong, China, 523059
        • Local Institution - 0326
        • Contact:
          • Site 0326
      • Guangzhou, Guangdong, China, 510080
        • Local Institution - 0331
        • Contact:
          • Site 0331
      • Zhongshan, Guangdong, China, 528403
        • Local Institution - 0478
        • Contact:
          • Site 0478
    • Guangxi
      • Guilin, Guangxi, China, 541199
        • Local Institution - 0321
        • Contact:
          • Site 0321
      • Nanning, Guangxi, China, 530021
        • Local Institution - 0328
        • Contact:
          • Site 0328
    • Hainan
      • Haikou, Hainan, China, 570000
        • Local Institution - 0330
        • Contact:
          • Site 0330
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Local Institution - 0343
        • Contact:
          • Site 0343
    • Henan
      • Weihui Shi, Henan, China, 453100
        • Local Institution - 0341
        • Contact:
          • Site 0341
      • Zhengzhou, Henan, China, 450000
        • Local Institution - 0480
        • Contact:
          • Site 0480
      • Zhengzhou, Henan, China, 450008
        • Local Institution - 0423
        • Contact:
          • Site 0423
    • Hubei
      • Jingzhou, Hubei, China
        • Local Institution - 0483
        • Contact:
          • Site 0483
      • Wuhan, Hubei, China, 430022
        • Local Institution - 0450
        • Contact:
          • Site 0450
    • Hunan
      • Changsha, Hunan, China, 410007
        • Local Institution - 0482
        • Contact:
          • Site 0482
      • Changsha Shi, Hunan, China, 410008
        • Local Institution - 0467
        • Contact:
          • Site 0467
      • Changsha Shi, Hunan, China, 410013
        • Local Institution - 0306
        • Contact:
          • Site 0306
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Local Institution - 0347
        • Contact:
          • Site 0347
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Local Institution - 0332
        • Contact:
          • Site 0332
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Local Institution - 0464
        • Contact:
          • Site 0464
    • Shandong
      • Binzhou, Shandong, China, 256603
        • Local Institution - 0479
        • Contact:
          • Site 0479
      • Weifang Shi, Shandong, China, 261000
        • Local Institution - 0469
        • Contact:
          • Site 0469
    • Shanghai Municipality
      • Shanghai Shi, Shanghai Municipality, China, 200120
        • Local Institution - 0319
        • Contact:
          • Site 0319
    • Shanxi
      • Taiyuan, Shanxi, China, 30001
        • Local Institution - 0316
        • Contact:
          • Site 0316
      • Taiyuan, Shanxi, China, 30013
        • Local Institution - 0463
        • Contact:
          • Site 0463
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution - 0456
        • Contact:
          • Site 0456
      • Chengdu, Sichuan, China, 610041
        • Local Institution - 0471
        • Contact:
          • Site 0471
      • Dazhou Shi, Sichuan, China, 635000
        • Local Institution - 0320
        • Contact:
          • Site 0320
      • Yibin, Sichuan, China, 644000
        • Local Institution - 0472
        • Contact:
          • Site 0472
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Local Institution - 0452
        • Contact:
          • Site 0452
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Local Institution - 0312
        • Contact:
          • Site 0312
  • France
      • Brest, France, 29200
        • Local Institution - 0073
        • Contact:
          • Site 0073
      • Caen, France, 14076
        • Local Institution - 0066
        • Contact:
          • Site 0066
      • Toulouse, France, 31059
        • Local Institution - 0070
        • Contact:
          • Site 0070
    • Bouches-Du-Rhône
      • Marseille, Bouches-Du-Rhône, France, 13915
        • Local Institution - 0074
        • Contact:
          • Site 0074
    • Côte-D'Or
      • Dijon, Côte-D'Or, France, 21079
        • Local Institution - 0063
        • Contact:
          • Site 0063
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44093
        • Local Institution - 0075
        • Contact:
          • Site 0075
    • Nan
      • La Tronche, Nan, France, 38700
        • Local Institution - 0064
        • Contact:
          • Site 0064
      • Lyon, Nan, France, 69373
        • Local Institution - 0116
        • Contact:
          • Site 0116
      • Paris, Nan, France, 75014
        • Local Institution - 0109
        • Contact:
          • Site 0109
    • Rhône
      • Bron, Rhône, France, 69677
        • Local Institution - 0062
        • Contact:
          • Site 0062
    • Val-De-Marne
      • Villejuif, Val-De-Marne, France, 94805
        • Local Institution - 0069
        • Contact:
          • Site 0069
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75248
        • Local Institution - 0071
        • Contact:
          • Site 0071
  • Germany
      • Giessen, Germany, 35392
        • Local Institution - 0445
        • Contact:
          • Site 0445
    • Baden-Wurttemberg
      • Gerlingen, Baden-Wurttemberg, Germany, 70839
        • Local Institution - 0112
        • Contact:
          • Site 0112
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Local Institution - 0111
      • Wangen, Baden-Wurttemberg, Germany, 88239
        • Local Institution - 0110
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Local Institution - 0001
        • Contact:
          • Site 0001
      • Regensburg, Bavaria, Germany, 93053
        • Local Institution - 0105
        • Contact:
          • Site 0105
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60389
        • Local Institution - 0446
        • Contact:
          • Site 0446
    • Lower Saxony
      • Oldenburg, Lower Saxony, Germany, 26121
        • Local Institution - 0106
        • Contact:
          • Site 0106
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Local Institution - 0100
        • Contact:
          • Site 0100
      • Dortmund, North Rhine-Westphalia, Germany, 44263
        • Local Institution - 0243
        • Contact:
          • Site 0243
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Local Institution - 0104
        • Contact:
          • Site 0104
      • Hemer, North Rhine-Westphalia, Germany, 58675
        • Local Institution - 0117
        • Contact:
          • Site 0117
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Local Institution - 0101
        • Contact:
          • Site 0101
    • Saxony
      • Dresden, Saxony, Germany, 1307
        • Local Institution - 0103
        • Contact:
          • Site 0103
      • Leipzig, Saxony, Germany, 4103
        • Local Institution - 0412
        • Contact:
          • Site 0412
    • Schleswig-Holstein
      • Großhansdorf, Schleswig-Holstein, Germany, 22927
        • Local Institution - 0108
        • Contact:
          • Site 0108
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Local Institution - 0239
        • Contact:
          • Site 0239
  • India
    • Gujarat
      • Vadodara, Gujarat, India, 361790
        • Local Institution - 0225
        • Contact:
          • Site 0225
    • Haryana
      • Badsa, Haryana, India, 124105
        • Local Institution - 0444
        • Contact:
          • Site 0444
      • Gurgaon, Haryana, India, 122001
        • Local Institution - 0337
        • Contact:
          • Site 0337
    • Karnataka
      • Belagavi, Karnataka, India, 590010
        • Local Institution - 0436
        • Contact:
          • Site 0436
    • Maharashtra
      • Pune, Maharashtra, India, 411013
        • Local Institution - 0215
        • Contact:
          • Site 0215
    • Punjab
      • Mohali, Punjab, India, 140901
        • Local Institution - 0233
        • Contact:
          • Site 0233
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600035
        • Local Institution - 0222
        • Contact:
          • Site 0222
  • Italy
      • Bergamo, Italy, 24128
        • Local Institution - 0093
        • Contact:
          • Site 0093
      • Brescia, Italy, 25123
        • Local Institution - 0289
        • Contact:
          • Site 0289
      • Milan, Italy, 20133
        • Local Institution - 0089
        • Contact:
          • Site 0089
      • Milan, Italy, 20141
        • Local Institution - 0087
        • Contact:
          • Site 0087
      • Milan, Italy, 20142
        • Local Institution - 0238
        • Contact:
          • Site 0238
      • Pavia, Italy, 27100
        • Local Institution - 0091
        • Contact:
          • Site 0091
      • Verona, Italy, 37126
        • Local Institution - 0088
        • Contact:
          • Site 0088
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italy, 47014
        • Local Institution - 0236
        • Contact:
          • Site 0236
    • Turin
      • Candiolo, Turin, Italy, 10060
        • Local Institution - 0094
        • Contact:
          • Site 0094
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Local Institution - 0262
        • Contact:
          • Site 0262
    • Ehime
      • Toon-Shi, Ehime, Japan, 791-0295
        • Local Institution - 0128
        • Contact:
          • Site 0128
    • Fukuoka
      • Kurume-Shi, Fukuoka, Japan, 830-0011
        • Local Institution - 0136
        • Contact:
          • Site 0136
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Local Institution - 0121
        • Contact:
          • Site 0121
    • Miyagi
      • Sendai, Miyagi, Japan, 980-0873
        • Local Institution - 0122
        • Contact:
          • Site 0122
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Local Institution - 0433
        • Contact:
          • Site 0433
    • Osaka
      • Hirakata-Shi, Osaka, Japan, 573-1191
        • Local Institution - 0125
        • Contact:
          • Site 0125
      • Osakasayama-Shi, Osaka, Japan, 589-8511
        • Local Institution - 0129
        • Contact:
          • Site 0129
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Local Institution - 0141
        • Contact:
          • Site 0141
    • Tokyo-To
      • Chūōku, Tokyo-To, Japan, 104-0045
        • Local Institution - 0137
        • Contact:
          • Site 0137
      • Kōtoku, Tokyo-To, Japan, 135-8550
        • Local Institution - 0414
        • Contact:
          • Site 0414
  • South Korea
      • Gyeongsangnam-do, South Korea, 050612
        • Local Institution - 0139
        • Contact:
          • Site 0139
      • Seoul, South Korea, 120-752
        • Local Institution - 0135
        • Contact:
          • Site 0135
      • Seoul, South Korea, 3080
        • Local Institution - 0131
        • Contact:
          • Site 0131
      • Seoul, South Korea, 8308
        • Local Institution - 0126
        • Contact:
          • Site 0126
    • Daegu
      • Buk-Gu, Daegu, South Korea, 41404
        • Local Institution - 0138
        • Contact:
          • Site 0138
      • Dalseo, Daegu, South Korea, 42601
        • Local Institution - 0506
        • Contact:
          • Site 0506
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 410-769
        • Local Institution - 0127
        • Contact:
          • Site 0127
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Local Institution - 0133
        • Contact:
          • Site 0133
    • Jeollanam-do
      • Hwasun-Gun, Jeollanam-do, South Korea, 58128
        • Local Institution - 0134
        • Contact:
          • Site 0134
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 361-711
        • Local Institution - 0140
        • Contact:
          • Site 0140
    • Seoul
      • Seocho -Gu, Seoul, South Korea, 6591
        • Local Institution - 0124
        • Contact:
          • Site 0124
      • Songpa-Gu, Seoul, South Korea, 138-736
        • Local Institution - 0123
        • Contact:
          • Site 0123
  • Spain
      • A Coruña, Spain, 15006
        • Local Institution - 0242
        • Contact:
          • Site 0242
      • Jaén, Spain, 23007
        • Local Institution - 0144
        • Contact:
          • Site 0144
      • Jaén, Spain, 23007
        • Local Institution - 0226
        • Contact:
          • Site 0226
      • Jerez de la Frontera, Spain, 11407
        • Local Institution - 0149
        • Contact:
          • Site 0149
      • Madrid, Spain, 28041
        • Local Institution - 0148
        • Contact:
          • Site 0148
      • Málaga, Spain, 29010
        • Local Institution - 0150
        • Contact:
          • Site 0150
      • Valencia, Spain, 46009
        • Local Institution - 0241
        • Contact:
          • Site 0241
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Local Institution - 0143
        • Contact:
          • Site 0143
    • Seville
      • Seville, Seville, Spain, 41013
        • Local Institution - 0147
        • Contact:
          • Site 0147
  • Taiwan
      • Taichung, Taiwan, 40201
        • Local Institution - 0418
        • Contact:
          • Site 0418
      • Tainan, Taiwan, 70428
        • Local Institution - 0420
        • Contact:
          • Site 0420
      • Taipei, Taiwan, 100225
        • Local Institution - 0419
        • Contact:
          • Site 0419
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Taiwan, 82445
        • Local Institution - 0229
        • Contact:
          • Site 0229
    • New Taipei
      • New Taipei City, New Taipei, Taiwan, 23561
        • Local Institution - 0230
        • Contact:
          • Site 0230
    • Taichung
      • Taipei, Taichung, Taiwan, 112
        • Local Institution - 0216
        • Contact:
          • Site 0216
    • Taiwan
      • Gaoxiongka, Taiwan, Taiwan, 807
        • Local Institution - 0227
        • Contact:
          • Site 0227
    • Taoyuan
      • Taoyuan City, Taoyuan, Taiwan, 33378
        • Local Institution - 0221
        • Contact:
          • Site 0221
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 1060
        • Local Institution - 0014
        • Contact:
          • Site 0014
      • Adana, Turkey (Türkiye), 1370
        • Local Institution - 0019
        • Contact:
          • Site 0019
      • Ankara, Turkey (Türkiye), 6680
        • Local Institution - 0008
        • Contact:
          • Site 0008
      • Ankara, Turkey (Türkiye), 6800
        • Local Institution - 0003
        • Contact:
          • Site 0003
      • Antalya, Turkey (Türkiye), 07100
        • Local Institution - 0015
        • Contact:
          • Site 0015
      • Istanbul, Turkey (Türkiye), 34214
        • Local Institution - 0041
        • Contact:
          • Site 0041
      • Istanbul, Turkey (Türkiye), 34295
        • Local Institution - 0039
        • Contact:
          • Site 0039
      • Izmir, Turkey (Türkiye), 35110
        • Local Institution - 0050
        • Contact:
          • Site 0050
      • Izmir, Turkey (Türkiye), 35530
        • Local Institution - 0037
        • Contact:
          • Site 0037
    • Diyarbakır
      • Sur, Diyarbakır, Turkey (Türkiye), 21200
        • Local Institution - 0021
        • Contact:
          • Site 0021
    • Istanbul
      • Pendik, Istanbul, Turkey (Türkiye), 34340
        • Local Institution - 0265
        • Contact:
          • Site 0265
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Local Institution - 0212
        • Contact:
          • Site 0212
      • Fullerton, California, United States, 92835
        • Local Institution - 0504
        • Contact:
          • Site 0504
      • La Jolla, California, United States, 92093
        • Local Institution - 0357
        • Contact:
          • Site 0357
    • Colorado
      • Pueblo, Colorado, United States, 81003
        • Local Institution - 0520
        • Contact:
          • Site 0520
    • Florida
      • Orlando, Florida, United States, 32806
        • Local Institution - 0366
        • Contact:
          • Site 0366
      • Palm Bay, Florida, United States, 32901
        • Local Institution - 0519
        • Contact:
          • Site 0519
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Local Institution - 0210
        • Contact:
          • Site 0210
    • Illinois
      • Ottawa, Illinois, United States, 61350
        • Local Institution - 0207
        • Contact:
          • Site 0207
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Local Institution - 0503
        • Contact:
          • Site 0503
      • Silver Spring, Maryland, United States, 20904
        • Local Institution - 0523
        • Contact:
          • Site 0523
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Local Institution - 0521
        • Contact:
          • Site 0521
      • Saint Paul, Minnesota, United States, 55102
        • Local Institution - 0364
        • Contact:
          • Site 0364
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0403
        • Contact:
          • Site 0403
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Local Institution - 0402
        • Contact:
          • Site 0402
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Local Institution - 0290
        • Contact:
          • Site 0290
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Local Institution - 0183
        • Contact:
          • Site 0183
    • New York
      • New York, New York, United States, 10021
        • Local Institution - 0153
        • Contact:
          • Site 0153
      • The Bronx, New York, United States, 10461
        • Local Institution - 0157
        • Contact:
          • Site 0157
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0385
        • Contact:
          • Site 0385
    • Ohio
      • Sandusky, Ohio, United States, 44870
        • Local Institution - 0438
        • Contact:
          • Site 0438
    • Oregon
      • Portland, Oregon, United States, 97213
        • Local Institution - 0404
        • Contact:
          • Site 0404
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • Local Institution - 0487
        • Contact:
          • Site 0487
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Local Institution - 0200
        • Contact:
          • Site 0200
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Local Institution - 0199
        • Contact:
          • Site 0199
    • Texas
      • Beaumont, Texas, United States, 77702
        • Local Institution - 0522
        • Contact:
          • Site 0522
      • Dallas, Texas, United States, 75246
        • Local Institution - 0525
        • Contact:
          • Site 0525
      • San Antonio, Texas, United States, 78217
        • Local Institution - 0529
        • Contact:
          • Site 0529
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Local Institution - 0411
        • Contact:
          • Site 0411
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Local Institution - 0165
        • Contact:
          • Site 0165
      • Fairfax, Virginia, United States, 22031
        • Local Institution - 0530
        • Contact:
          • Site 0530
      • Winchester, Virginia, United States, 22601
        • Local Institution - 0528
        • Contact:
          • Site 0528
    • Washington
      • Seattle, Washington, United States, 98104
        • Local Institution - 0283
        • Contact:
          • Site 0283
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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
Intervention / Treatment
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: Cisplatin
Specified dose on specified days
Drug: Pemetrexed
Specified dose on specified days
Drug: Osimertinib
Specified dose on days

What is the study measuring?

Primary Outcome Measures

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

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

Bristol-Myers Squibb

Investigators

  • 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 (Estimated)

September 30, 2026

Primary Completion (Estimated)

December 30, 2031

Study Completion (Estimated)

December 30, 2031

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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