Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)
IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy
4 other identifiers
interventional
596
25 countries
186
Brief Summary
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Nov 2025
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
186 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedStudy Start
First participant enrolled
November 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 15, 2031
April 16, 2026
April 1, 2026
2.9 years
July 31, 2025
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Recommended Phase 3 Dose (RP3D) of BMS-986507
Phase 2
Approximately 3 months after the first dose
Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Phase 3
Up to 3 years
Secondary Outcomes (8)
Objective Response (OR) Assessed by RECIST v1.1 per BICR
Up to 3 years
PFS Assessed by RECIST v1.1 per BICR
Up to 3 years
Overall Survival (OS)
Up to 5 years
PFS Assessed by RECIST v1.1 per investigator assessment
Up to 3 years
OR Assessed by RECIST v1.1 per BICR
Up to 3 years
- +3 more secondary outcomes
Study Arms (5)
Arm A
EXPERIMENTALArm B
EXPERIMENTALArm C
ACTIVE COMPARATORArm D
EXPERIMENTALArm E
ACTIVE COMPARATORInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Non-squamous NSCLC, not amenable to treatment in curative intent.
- Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).
- Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.
- Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).
You may not qualify if:
- Inadequate organ function and/or bone marrow reserve.
- Leptomeningeal metastases or spinal cord compression.
- Poorly controlled systemic medical conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (186)
Local Institution - 0279
Irvine, California, 92612, United States
Local Institution - 0154
Orange, California, 92868, United States
Shaw Cancer Center
Edwards, Colorado, 81632, United States
Local Institution - 0085
Gainesville, Florida, 32610, United States
Local Institution - 0142
Pembroke Pines, Florida, 33028, United States
Piedmont Healthcare
Atlanta, Georgia, 30318, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Local Institution - 0153
Chicago, Illinois, 60612, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Washington University School of Medicine
St Louis, Missouri, 63108, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
NYU Langone Health
New York, New York, 10016, United States
Local Institution - 0158
New York, New York, 10065, United States
Rochester General Hospital Infectious Disease
Rochester, New York, 14621, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Local Institution - 0284
Columbus, Ohio, 43210, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Local Institution - 0171
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Local Institution - 0088
Pittsburgh, Pennsylvania, 15212, United States
Local Institution - 0268
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Local Institution - 0025
Houston, Texas, 77030, United States
Local Institution - 0173
San Antonio, Texas, 78229, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University (Vcu)
Richmond, Virginia, 23219, United States
Local Institution - 0008
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Local Institution - 0004
ABB, Buenos Aires F.D., C1199ABB, Argentina
Local Institution - 0094
Córdoba, Córdoba Province, 5016, Argentina
Local Institution - 0280
Wilrijk, Antwerpen, 2610, Belgium
Local Institution - 0161
Auderghem, Bruxelles-Capitale, Région de, 1160, Belgium
Local Institution - 0022
Yvoir, Namur, 5530, Belgium
Local Institution - 0023
Ghent, Oost-Vlaanderen, 9000, Belgium
Local Institution - 0024
Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium
Local Institution - 0190
Calgary, Alberta, T2N 5G2, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Local Institution - 0184
Chicoutimi, Quebec, G7H 5H6, Canada
Local Institution - 0185
Montreal, Quebec, H4J 1C5, Canada
Local Institution - 0006
Santiago, Santiago Metropolitan, 0, Chile
Local Institution - 0005
Santiago, Santiago Metropolitan, 7500921, Chile
Local Institution - 0007
Santiago, Santiago Metropolitan, 8420383, Chile
Local Institution - 0244
Beijing, Beijing Municipality, 100142, China
Local Institution - 0259
Chongqing, Chongqing Municipality, 400030, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Jiangmen Center Hospital
Jiangmen, Guangdong, 0, China
Local Institution - 0271
Anyang, Henan, 455000, China
Local Institution - 0261
Luoyang, Henan, 471003, China
Local Institution - 0267
Jingzhou, Hubei, 0, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Local Institution - 0255
Changsha, Hunan, 410013, China
Local Institution - 0256
Xuzhou, Jiangsu, 221009, China
Local Institution - 0247
Nanchang, Jiangxi, 330209, China
Local Institution - 0246
Changchun, Jilin, 130000, China
Local Institution - 0257
Shenyang, Liaoning, 110001, China
Local Institution - 0248
Jinan, Shandong, 250117, China
Local Institution - 0250
Shanghai, Shanghai Municipality, 200030, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000, China
Local Institution - 0252
Hangzhou, Zhejiang, 310022, China
Local Institution - 0251
Linhai, Zhejiang, 317000, China
Local Institution - 0260
Nanning, 530021, China
Local Institution - 0249
Shanghai, 200032, China
Local Institution - 0229
Valledupar, Cesar Department, 200001, Colombia
Local Institution - 0228
Bogotá, Cundinamarca, 111511, Colombia
Local Institution - 0227
Montería, Departamento de Córdoba, 230002, Colombia
Local Institution - 0226
Cali, Valle del Cauca Department, 760032, Colombia
Local Institution - 0014
Strasbourg, Alsace, 67091, France
Local Institution - 0017
Toulouse, Haute-Garonne, 31059, France
Local Institution - 0010
Lille, Hauts-de-France, 59037, France
Local Institution - 0018
La Tronche, Isère, 38700, France
Local Institution - 0170
Saint-Herblain, Loire-Atlantique, 44805, France
Local Institution - 0162
Bron, Rhône, 69677, France
Local Institution - 0019
Villejuif, Val-de-Marne, 94800, France
Local Institution - 0012
Marseille, 13915, France
Local Institution - 0278
Nantes, 44200, France
Local Institution - 0011
Paris, 75248, France
Local Institution - 0015
Paris, 75970, France
Local Institution - 0207
Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany
Local Institution - 0238
Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany
Local Institution - 0212
Stuttgart, Baden-Wurttemberg, 70376, Germany
Local Institution - 0236
Donauwörth, Bavaria, 86609, Germany
Local Institution - 0209
Oldenburg, Lower Saxony, 26121, Germany
Local Institution - 0213
Cologne, North Rhine-Westphalia, 51109, Germany
Local Institution - 0208
Chemnitz, Saxony, 09116, Germany
Local Institution - 0274
Kiel, Schleswig-Holstein, 24105, Germany
Local Institution - 0211
Berlin, 13125, Germany
Local Institution - 0215
Gauting, 82131, Germany
Local Institution - 0242
Hamburg, 22307, Germany
Local Institution - 0210
Heidelberg, 69126, Germany
Local Institution - 0239
Kassel, 34125, Germany
Local Institution - 0241
Ulm, 89081, Germany
Local Institution - 0054
Athens, Attikí, 115 27, Greece
Local Institution - 0060
Chaïdári, Attikí, 124 62, Greece
Local Institution - 0056
Thessaloniki, Kentrikí Makedonía, 540 07, Greece
Local Institution - 0062
Thessaloniki, Thessaloníki, 570 10, Greece
Local Institution - 0083
Ahmedabad, Gujarat, 380016, India
Local Institution - 0073
Ahmedabad, Gujarat, 380054, India
Local Institution - 0072
Gurugram, Haryana, 122001, India
Local Institution - 0069
Bengaluru, Karnataka, 560017, India
Local Institution - 0077
Mumbai, Maharashtra, 400 057, India
Local Institution - 0071
Mumbai, Maharashtra, 400012, India
Local Institution - 0097
Nagpur, Maharashtra, 440001, India
Local Institution - 0070
New Delhi, National Capital Territory of Delhi, 110029, India
Local Institution - 0078
Howrah, West Bengal, 711103, India
Local Institution - 0028
Ravenna, Emilia-Romagna, 48121, Italy
Local Institution - 0036
Aviano, Friuli Venezia Giulia, 33081, Italy
Local Institution - 0031
Orbassano, Piedmont, 10043, Italy
Local Institution - 0277
Candiolo, Torino, 10060, Italy
Local Institution - 0137
Avellino, 83100, Italy
Local Institution - 0032
Milan, 20141, Italy
Local Institution - 0034
Naples, 80131, Italy
Local Institution - 0029
Parma, 43126, Italy
Local Institution - 0196
Nagoya, Aichi-ken, 464-8681, Japan
Local Institution - 0191
Kashiwa, Chiba, 277-8577, Japan
Local Institution - 0203
Tōon, Ehime, 791-0295, Japan
Local Institution - 0201
Kurume, Fukuoka, 830-0011, Japan
Local Institution - 0217
Sapporo, Hokkaido, 003-0804, Japan
Local Institution - 0199
Nishinomiya, Hyōgo, 663-8501, Japan
Local Institution - 0193
Yokohama, Kanagawa, 2418515, Japan
Local Institution - 0192
Sendai, Miyagi, 9810914, Japan
Local Institution - 0200
Kurashiki, Okayama-ken, 710-8602, Japan
Local Institution - 0198
Hirakata, Osaka, 573-1191, Japan
Local Institution - 0204
Ōsaka-sayama, Osaka, 589-8511, Japan
Local Institution - 0194
Ina-machi, Saitama, 362-0806, Japan
Local Institution - 0197
Hamamatsu, Shizuoka, 431-3192, Japan
Local Institution - 0195
Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777, Japan
Local Institution - 0202
Koto-ku, Tokyo, 135-8550, Japan
Local Institution - 0225
Mexico City, Mexico City, 03100, Mexico
Local Institution - 0224
Oaxaca City, Oaxaca, 68020, Mexico
Local Institution - 0222
Chihuahua City, 31203, Mexico
Local Institution - 0223
Mexico City, 14210, Mexico
Local Institution - 0163
Harderwijk, Gelderland, 3844 DG, Netherlands
Local Institution - 0216
Amsterdam, North Holland, 1066 CX, Netherlands
Local Institution - 0164
Amsterdam, North Holland, 1081 HV, Netherlands
Local Institution - 0103
Drammen, Buskerud, 3004, Norway
Local Institution - 0106
Bergen, Hordaland, 5021, Norway
Local Institution - 0105
Oslo, 0450, Norway
Local Institution - 0220
Lublin, Lublin Voivodeship, 20-954, Poland
Local Institution - 0231
Gdynia, Pomeranian Voivodeship, 81-519, Poland
Local Institution - 0219
Bydgoszcz, 85796, Poland
Local Institution - 0120
Bucharest, Bucharest, 013812, Romania
Local Institution - 0123
Bucharest, Bucharest, 022328, Romania
Local Institution - 0132
Florești, Cluj, 407280, Romania
Local Institution - 0130
Craiova, Dolj, 200746, Romania
Local Institution - 0115
Bucharest, 020335, Romania
Local Institution - 0133
Cluj-Napoca, 400015, Romania
Local Institution - 0124
Iași, 700106, Romania
Local Institution - 0119
Iași, 700483, Romania
Local Institution - 0263
Singapore, 169610, Singapore
Local Institution - 0262
Singapore, 308442, Singapore
Local Institution - 0089
Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, South Korea
Local Institution - 0043
Goyang-si, Kyǒnggi-do, 10408, South Korea
Local Institution - 0044
Seongnam, Kyǒnggi-do, 13620, South Korea
Local Institution - 0046
Suwon, Kyǒnggi-do, 16247, South Korea
Local Institution - 0095
Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Local Institution - 0045
Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea
Local Institution - 0092
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Local Institution - 0042
Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
Local Institution - 0218
Barcelona, Barcelona [Barcelona], 08035, Spain
Local Institution - 0177
Barcelona, Catalunya [Cataluña], 08041, Spain
Local Institution - 0175
Madrid, Madrid, Comunidad de, 28009, Spain
Local Institution - 0206
Madrid, Madrid, Comunidad de, 28041, Spain
Local Institution - 0176
Madrid, Madrid, Comunidad de, 28046, Spain
Local Institution - 0181
Majadahonda, Madrid, Comunidad de, 28222, Spain
Local Institution - 0178
Málaga, 29011, Spain
Local Institution - 0182
Seville, 41013, Spain
Local Institution - 0180
Valencia, 46026, Spain
Local Institution - 0179
Zaragoza, 50009, Spain
Kantonsspital Baden
Baden, Canton of Aargau, 5404, Switzerland
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Local Institution - 0189
Bellinzona, 6500, Switzerland
E-Da hospital
Kaohsiung City, 82445, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Local Institution - 0265
Bangkok, Bangkok, 10700, Thailand
Local Institution - 0272
Mueng, Changwat Khon Kaen, 40002, Thailand
Local Institution - 0264
Bangkok, 10330, Thailand
Local Institution - 0266
Songkhla, 90110, Thailand
Local Institution - 0110
Glasgow, Glasgow City, G12 0YN, United Kingdom
Local Institution - 0061
London, Kensington and Chelsea, SW3 6JJ, United Kingdom
Local Institution - 0140
London, London, City of, E1 1RD, United Kingdom
Local Institution - 0281
Sulton, Surrey, SM25PT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2025
First Posted
August 3, 2025
Study Start
November 5, 2025
Primary Completion (Estimated)
September 15, 2028
Study Completion (Estimated)
May 15, 2031
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See 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