Non-Small Cell Lung CancerPhase 2/3NCT07100080
Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)
A Phase 2/3 study testing Iza-bren, Carboplatin and Cisplatin in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 187 sites in 25 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Iza-bren, Carboplatin and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 187 sitesin 25 countries
- Study dates
- 5 Nov 2025to 15 Nov 2030
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Inadequate organ function and/or bone marrow reserve.
- Leptomeningeal metastases or spinal cord compression.
- Poorly controlled systemic medical conditions.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
187 sites in 25 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
187 sites in 25 countries
United States28 sites, 26 recruiting
- Recruiting
Piedmont Healthcare
Atlanta, Georgia, 30318
Andrew Pippas, Site 0270, 706-660-6449
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Julia Rotow, Site 0067, 617-632-6049
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22908
Ryan Gentzler, Site 0145, 434-924-4251
- Withdrawn
Local Institution - 0268
Chattanooga, Tennessee, 37404
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60607
Helen Ross, Site 0153, 312-942-5904
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Matthew Mirsky, Site 0087, 301-980-8969
- Recruiting
John B Amos Cancer Center
Columbus, Georgia, 31904
Andrew Pippas, Site 0143, 706-660-6449
- Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Columbus, Ohio, 43210
Regan Memmott, Site 0284, 614-688-7567
- Recruiting
Shaw Cancer Center
Edwards, Colorado, 81632
Erin Schwab, Site 0139, 970-569-7608
- Withdrawn
Local Institution - 0085
Gainesville, Florida, 32610
- Not yet recruiting
Local Institution - 0025
Houston, Texas, 77030
Site 0025
- Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care building
Irvine, California, 92612
Cathleen Park, Site 0279
- Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
Rajwanth Veluswamy, Site 0269, 212-731-5662
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Wade Iams, Site 0093, 615-322-4967
- Recruiting
NYU Langone Health
New York, New York, 10016
Rajwanth Veluswamy, Site 0090, 212-731-5662
- Recruiting
Weill Cornell Medical College
New York, New York, 10065
Ashish Saxena, Site 0158, 631-745-0359
- Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868-3201
Cathleen Park, Site 0154
- Not yet recruiting
Local Institution - 0142
Pembroke Pines, Florida, 33028
Site 0142
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Melina Marmarelis, Site 0205, 267-438-8154
- Recruiting
West Penn Allegheny Health
Pittsburgh, Pennsylvania, 15224
Ariel Lopez Chavez, Site 0088, 503-494-8426
- Recruiting
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
Rachel Sanborn, Site 0038, 503-215-5696
- Recruiting
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Rachel Sanborn, Site 0275, 503-215-5696
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Rajat Thawani, Site 0171
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Katharine Thomas, Site 0276, 775-985-4000
- Recruiting
Virginia Commonwealth University (Vcu)
Richmond, Virginia, 23219
Renato Martins, Site 0138, 804-828-7999
- Recruiting
Rochester General Hospital Infectious Disease
Rochester, New York, 14621
MEHUL PATEL, Site 0186, 585-922-4020
- Not yet recruiting
Local Institution - 0173
San Antonio, Texas, 78229
Site 0173
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63108
Ece Cali Daylan, Site 0091, 314-273-8008
China20 sites, 20 recruiting
- Not yet recruiting
Local Institution - 0271
Anyang, Henan, 455000
Site 0271
- Not yet recruiting
Local Institution - 0244
Beijing, Beijing Municipality, 100142
Site 0244
- Not yet recruiting
Local Institution - 0246
Changchun, Jilin, 130000
Site 0246
- Not yet recruiting
Local Institution - 0255
Changsha, Hunan, 410013
Site 0255
- Not yet recruiting
Local Institution - 0259
Chongqing, Chongqing Municipality, 400030
Site 0259
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Haipeng Xu, Site 0253, 8613675007687
- Not yet recruiting
Local Institution - 0252
Hangzhou, Zhejiang, 310022
Site 0252
- Recruiting
Jiangmen Center Hospital
Jiangmen, Guangdong, 350008
DAREN LIN, Site 0245, +8613802607246
- Not yet recruiting
Local Institution - 0248
Jinan, Shandong, 250117
Site 0248
- Not yet recruiting
Local Institution - 0267
Jingzhou, Hubei, 0
Site 0267
- Not yet recruiting
Local Institution - 0251
Linhai, Zhejiang, 317000
Site 0251
- Not yet recruiting
Local Institution - 0261
Luoyang, Henan, 471003
Site 0261
- Not yet recruiting
Local Institution - 0247
Nanchang, Jiangxi, 330209
Site 0247
- Not yet recruiting
Local Institution - 0260
Nanning, 530021
Site 0260
- Not yet recruiting
Local Institution - 0250
Shanghai, Shanghai Municipality, 200030
Site 0250
- Not yet recruiting
Local Institution - 0249
Shanghai, Shanghai Municipality, 200032
Site 0249
- Not yet recruiting
Local Institution - 0257
Shenyang, Liaoning, 110001
Site 0257
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000
wei guo, Site 0258, 13834563396
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030
Qian Chu, Site 0243, 8613212760751
- Not yet recruiting
Local Institution - 0256
Xuzhou, Jiangsu, 221009
Site 0256
Japan16 sites, 15 recruiting
- Not yet recruiting
Local Institution - 0287
Chuo-ku, Tokyo, 104-0045
Site 0287
- Not yet recruiting
Local Institution - 0197
Hamamatsu, Shizuoka, 431-3192
Site 0197
- Not yet recruiting
Local Institution - 0198
Hirakata, Osaka, 573-1191
Site 0198
- Withdrawn
Local Institution - 0194
Ina-machi, Saitama, 362-0806
- Not yet recruiting
Local Institution - 0191
Kashiwa, Chiba, 277-8577
Site 0191
- Not yet recruiting
Local Institution - 0202
Koto-ku, Tokyo, 135-8550
Site 0202
- Not yet recruiting
Local Institution - 0200
Kurashiki, Okayama-ken, 710-8602
Site 0200
- Not yet recruiting
Local Institution - 0201
Kurume, Fukuoka, 830-0011
Site 0201
- Not yet recruiting
Local Institution - 0195
Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777
Site 0195
- Not yet recruiting
Local Institution - 0196
Nagoya, Aichi-ken, 464-8681
Site 0196
- Not yet recruiting
Local Institution - 0199
Nishinomiya, Hyōgo, 663-8501
Site 0199
- Not yet recruiting
Local Institution - 0204
Ōsaka-sayama, Osaka, 589-8511
Site 0204
- Not yet recruiting
Local Institution - 0217
Sapporo, Hokkaido, 003-0804
Site 0217
- Not yet recruiting
Local Institution - 0192
Sendai, Miyagi, 9810914
Site 0192
- Not yet recruiting
Local Institution - 0203
Tōon, Ehime, 791-0295
Site 0203
- Not yet recruiting
Local Institution - 0193
Yokohama, Kanagawa, 2418515
Site 0193
Germany14 sites, 14 recruiting
- Not yet recruiting
Local Institution - 0211
Berlin, 13125
Site 0211
- Not yet recruiting
Local Institution - 0208
Chemnitz, Saxony, 09116
Site 0208
- Not yet recruiting
Local Institution - 0213
Cologne, North Rhine-Westphalia, 51109
Site 0213
- Not yet recruiting
Local Institution - 0236
Donauwörth, Bavaria, 86609
Site 0236
- Not yet recruiting
Local Institution - 0207
Esslingen am Neckar, Baden-Wurttemberg, 73730
Site 0207
- Not yet recruiting
Local Institution - 0238
Esslingen am Neckar, Baden-Wurttemberg, 73730
Site 0238
- Not yet recruiting
Local Institution - 0215
Gauting, 82131
Site 0215
- Not yet recruiting
Local Institution - 0242
Hamburg, 22307
Site 0242
- Not yet recruiting
Local Institution - 0210
Heidelberg, 69126
Site 0210
- Not yet recruiting
Local Institution - 0239
Kassel, 34125
Site 0239
- Not yet recruiting
Local Institution - 0274
Kiel, Schleswig-Holstein, 24105
Site 0274
- Not yet recruiting
Local Institution - 0209
Oldenburg, Lower Saxony, 26121
Site 0209
- Not yet recruiting
Local Institution - 0212
Stuttgart, Baden-Wurttemberg, 70376
Site 0212
- Not yet recruiting
Local Institution - 0241
Ulm, 89081
Site 0241
France11 sites, 11 recruiting
- Not yet recruiting
Local Institution - 0162
Bron, Rhône, 69677
Site 0162
- Not yet recruiting
Local Institution - 0018
La Tronche, Isère, 38700
Site 0018
- Not yet recruiting
Local Institution - 0010
Lille, Hauts-de-France, 59037
Site 0010
- Not yet recruiting
Local Institution - 0012
Marseille, 13915
Site 0012
- Not yet recruiting
Local Institution - 0278
Nantes, 44200
Site 0278
- Not yet recruiting
Local Institution - 0011
Paris, 75248
Site 0011
- Not yet recruiting
Local Institution - 0015
Paris, 75970
Site 0015
- Not yet recruiting
Local Institution - 0170
Saint-Herblain, Loire-Atlantique, 44805
Site 0170
- Not yet recruiting
Local Institution - 0014
Strasbourg, Alsace, 67091
Site 0014
- Not yet recruiting
Local Institution - 0017
Toulouse, Haute-Garonne, 31059
Site 0017
- Not yet recruiting
Local Institution - 0019
Villejuif, Val-de-Marne, 94800
Site 0019
Spain10 sites, 10 recruiting
- Not yet recruiting
Local Institution - 0218
Barcelona, Barcelona [Barcelona], 08035
Site 0218
- Not yet recruiting
Local Institution - 0177
Barcelona, Catalunya [Cataluña], 08041
Site 0177
- Not yet recruiting
Local Institution - 0175
Madrid, Madrid, Comunidad de, 28009
Site 0175
- Not yet recruiting
Local Institution - 0206
Madrid, Madrid, Comunidad de, 28041
Site 0206
- Not yet recruiting
Local Institution - 0176
Madrid, Madrid, Comunidad de, 28046
Site 0176
- Not yet recruiting
Local Institution - 0181
Majadahonda, Madrid, Comunidad de, 28222
Site 0181
- Not yet recruiting
Local Institution - 0178
Málaga, 29011
Site 0178
- Not yet recruiting
Local Institution - 0182
Seville, 41013
Site 0182
- Not yet recruiting
Local Institution - 0180
Valencia, 46026
Site 0180
- Not yet recruiting
Local Institution - 0179
Zaragoza, 50009
Site 0179
India9 sites, 5 recruiting
- Withdrawn
Local Institution - 0083
Ahmedabad, Gujarat, 380016
- Withdrawn
Local Institution - 0073
Ahmedabad, Gujarat, 380054
- Not yet recruiting
Local Institution - 0069
Bengaluru, Karnataka, 560017
Site 0069
- Withdrawn
Local Institution - 0072
Gurugram, Haryana, 122001
- Withdrawn
Local Institution - 0078
Howrah, West Bengal, 711103
- Not yet recruiting
Local Institution - 0077
Mumbai, Maharashtra, 400 057
Site 0077
- Not yet recruiting
Local Institution - 0071
Mumbai, Maharashtra, 400012
Site 0071
- Not yet recruiting
Local Institution - 0097
Nagpur, Maharashtra, 440001
Site 0097
- Not yet recruiting
Local Institution - 0070
New Delhi, National Capital Territory of Delhi, 110029
Site 0070
Italy8 sites, 8 recruiting
- Not yet recruiting
Local Institution - 0137
Avellino, 83100
Site 0137
- Not yet recruiting
Local Institution - 0036
Aviano, Friuli Venezia Giulia, 33081
Site 0036
- Not yet recruiting
Local Institution - 0277
Candiolo, Torino, 10060
Site 0277
- Not yet recruiting
Local Institution - 0032
Milan, 20141
Site 0032
- Not yet recruiting
Local Institution - 0034
Naples, 80131
Site 0034
- Not yet recruiting
Local Institution - 0031
Orbassano, Piedmont, 10043
Site 0031
- Not yet recruiting
Local Institution - 0029
Parma, 43126
Site 0029
- Not yet recruiting
Local Institution - 0028
Ravenna, Emilia-Romagna, 48121
Site 0028
Romania8 sites, 6 recruiting
- Withdrawn
Local Institution - 0120
Bucharest, Bucharest, 013812
- Not yet recruiting
Local Institution - 0123
Bucharest, Bucharest, 022328
Site 0123
- Not yet recruiting
Local Institution - 0115
Bucharest, 020335
Site 0115
- Not yet recruiting
Local Institution - 0133
Cluj-Napoca, 400015
Site 0133
- Not yet recruiting
Local Institution - 0130
Craiova, Dolj, 200746
Site 0130
- Withdrawn
Local Institution - 0132
Florești, Cluj, 407280
- Not yet recruiting
Local Institution - 0124
Iași, 700106
Site 0124
- Not yet recruiting
Local Institution - 0119
Iași, 700483
Site 0119
South Korea8 sites, 8 recruiting
- Not yet recruiting
Local Institution - 0089
Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644
Site 0089
- Not yet recruiting
Local Institution - 0043
Goyang-si, Kyǒnggi-do, 10408
Site 0043
- Not yet recruiting
Local Institution - 0044
Seongnam, Kyǒnggi-do, 13620
Site 0044
- Not yet recruiting
Local Institution - 0095
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Site 0095
- Not yet recruiting
Local Institution - 0045
Seoul, Seoul-teukbyeolsi [Seoul], 03722
Site 0045
- Not yet recruiting
Local Institution - 0092
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Site 0092
- Not yet recruiting
Local Institution - 0042
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Site 0042
- Not yet recruiting
Local Institution - 0046
Suwon, Kyǒnggi-do, 16247
Site 0046
Taiwan6 sites, 6 recruiting
- Recruiting
E-Da hospital
Kaohsiung City, 82445
Yu-Feng Wei, Site 0053, +88676150011ext.5056
- Recruiting
Taichung Veterans General Hospital
Taichung, 407
Tsung-Ying Yang, Site 0050, 8864235925253218
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Chien-Chung Lin, Site 0049, +886-2353535-3117
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Jin-Yuan Shih, Site 0048, 88622312345662905
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Chao-Hua Chiu, Site 0047, 886227372181-3599
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Yung-Hung Luo, Site 0160, 886921770588
Belgium5 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0161
Auderghem, Bruxelles-Capitale, Région de, 1160
Site 0161
- Not yet recruiting
Local Institution - 0023
Ghent, Oost-Vlaanderen, 9000
Site 0023
- Not yet recruiting
Local Institution - 0024
Sint-Niklaas, Oost-Vlaanderen, B-9100
Site 0024
- Not yet recruiting
Local Institution - 0280
Wilrijk, Antwerpen, 2610
Site 0280
- Not yet recruiting
Local Institution - 0022
Yvoir, Namur, 5530
Site 0022
Canada4 sites, 3 recruiting
- Recruiting
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Doreen Ezeife, Site 0190, 0000000000
- Not yet recruiting
Local Institution - 0184
Chicoutimi, Quebec, G7H 5H6
Site 0184
- Withdrawn
Local Institution - 0185
Montreal, Quebec, H4J 1C5
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Natasha Leighl, Site 0183, 4169464645
Colombia4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0228
Bogotá, Cundinamarca, 111511
Site 0228
- Not yet recruiting
Local Institution - 0226
Cali, Valle del Cauca Department, 760032
Site 0226
- Not yet recruiting
Local Institution - 0227
Montería, Departamento de Córdoba, 230002
Site 0227
- Not yet recruiting
Local Institution - 0229
Valledupar, Cesar Department, 200001
Site 0229
Greece4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0054
Athens, Attikí, 115 27
Site 0054
- Not yet recruiting
Local Institution - 0060
Chaïdári, Attikí, 124 62
Site 0060
- Not yet recruiting
Local Institution - 0056
Thessaloniki, Kentrikí Makedonía, 540 07
Site 0056
- Not yet recruiting
Local Institution - 0062
Thessaloniki, Thessaloníki, 570 10
Site 0062
Mexico4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0222
Chihuahua City, 31203
Site 0222
- Not yet recruiting
Local Institution - 0225
Mexico City, Mexico City, 03100
Site 0225
- Not yet recruiting
Local Institution - 0223
Mexico City, 14210
Site 0223
- Not yet recruiting
Local Institution - 0224
Oaxaca City, Oaxaca, 68020
Site 0224
Thailand4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0265
Bangkok, Bangkok, 10700
Site 0265
- Not yet recruiting
Local Institution - 0264
Bangkok, 10330
Site 0264
- Not yet recruiting
Local Institution - 0272
Mueng, Changwat Khon Kaen, 40002
Site 0272
- Not yet recruiting
Local Institution - 0266
Songkhla, 90110
Site 0266
United Kingdom4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0110
Glasgow, Glasgow City, G12 0YN
Site 0110
- Not yet recruiting
Local Institution - 0061
London, Kensington and Chelsea, SW3 6JJ
Site 0061
- Not yet recruiting
Local Institution - 0140
London, London, City of, E1 1RD
Site 0140
- Not yet recruiting
Local Institution - 0281
Sulton, Surrey, SM25PT
Site 0281
Argentina3 sites, 3 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., C1199ABB
Lorena Lupinacci, Site 0004, 5411495902008159
- Recruiting
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
Florencia Tsou, Site 0008, 5411322189001189
- Recruiting
Hospital Privado Universitario de Córdoba
Córdoba, 5016
Claudia Martin, Site 0094, 00543515590424
Chile3 sites, 3 recruiting
- Recruiting
Orlandi Oncologia
Santiago, Santiago Metropolitan, 0
Cristián Ibarra, Site 0006, 976887987
- Recruiting
FALP
Santiago, Santiago Metropolitan, 7500921
Christian Caglevic, Site 0005, 56224457254
- Recruiting
Bradfordhill
Santiago, Santiago Metropolitan, 8420383
Carlos Rojas, Site 0007, +56998744662
Netherlands3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0216
Amsterdam, North Holland, 1066 CX
Site 0216
- Not yet recruiting
Local Institution - 0164
Amsterdam, North Holland, 1081 HV
Site 0164
- Not yet recruiting
Local Institution - 0163
Harderwijk, Gelderland, 3844 DG
Site 0163
Norway3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0106
Bergen, Hordaland, 5021
Site 0106
- Not yet recruiting
Local Institution - 0103
Drammen, Buskerud, 3004
Site 0103
- Not yet recruiting
Local Institution - 0105
Oslo, 0450
Site 0105
Poland3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0219
Bydgoszcz, 85796
Site 0219
- Not yet recruiting
Local Institution - 0220
Lublin, Lublin Voivodeship, 20-954
Site 0220
- Not yet recruiting
Local Institution - 0286
Poznan, Greater Poland Voivodeship, 60-569
Site 0286
Switzerland3 sites, 3 recruiting
- Recruiting
Kantonsspital Baden
Baden, Canton of Aargau, 5404
Sacha Rothschild, Site 0188, 0041564862762
- Not yet recruiting
Local Institution - 0189
Bellinzona, 6500
Site 0189
- Recruiting
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Markus Joerger, Site 0187, 41714941111
Singapore2 sites, 2 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Wan Ling Tan, Site 0263
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Puey Ling Chia, Site 0262
About this study
Official title: 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
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Iza-bren, Carboplatin, Cisplatin, Pemetrexed
- Keywords
- Epidermal Growth Factor Receptor, Tyrosine Kinase Inhibitors, Osimertinib, Standard of Care, Lung Neoplasms, Antineoplastic Agents, Izalontamab brengitecan, Iza-bren, BL-B01D1, Carboplatin, Cisplatin, Pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iza-brenDrug
Also called BMS-986507, BL-B01D1, Izalontamab brengitecan
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
CisplatinDrug
Specified dose on specified days
PemetrexedDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Iza-bren |
| Arm B | Experimental | Not described Receives: Drug: Iza-bren |
| Arm C | Active comparator | Not described Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed |
| Arm D | Experimental | Not described Receives: Drug: Iza-bren |
| Arm E | Active comparator | Not described Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 3 Dose (RP3D) of BMS-986507
Phase 2
Measured: 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
Measured: Up to 3 years
Secondary outcomes (8)
Objective Response (OR) Assessed by RECIST v1.1 per BICR
Phase 2
Measured: Up to 3 years
PFS Assessed by RECIST v1.1 per BICR
Phase 2
Measured: Up to 3 years
Overall Survival (OS)
Phase 3
Measured: Up to 5 years
PFS Assessed by RECIST v1.1 per investigator assessment
Phase 3
Measured: Up to 3 years
OR Assessed by RECIST v1.1 per BICR
Phase 3
Measured: Up to 3 years
Disease Control Rate (DCR) Assessed by RECIST v1.1 per BICR
Phase 3
Measured: Up to 3 years
Duration of Response (DOR) Assessed by RECIST v1.1 per BICR
Phase 3
Measured: Up to 3 years
Time To Response (TTR) Assessed by RECIST v1.1 per BICR
Phase 3
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start5 Nov 2025
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100080
- Sponsor's protocol ID
- CA244-0010
- Other IDs
- EU CTR, WHO, CA2440010
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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