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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)

NCT07100080 · Bristol-Myers Squibb
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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
About this study
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
Eligibility criteria
Inclusion Criteria: * 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). Exclusion criteria: * 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.
Study design
Enrollment target: 500 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-05
Estimated completion: 2030-11-15
Last updated: 2026-08-25
Interventions
Drug: Iza-brenDrug: CarboplatinDrug: CisplatinDrug: Pemetrexed
Primary outcomes
  • Recommended Phase 3 Dose (RP3D) of BMS-986507 (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) (Up to 3 years)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (186)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care buildingRecruiting
Irvine, California, United States
University of California, Irvine (UCI) Health - UC Irvine Medical CenterRecruiting
Orange, California, United States
Shaw Cancer CenterRecruiting
Edwards, Colorado, United States
Local Institution - 0085Withdrawn
Gainesville, Florida, United States
Local Institution - 0142Not Yet Recruiting
Pembroke Pines, Florida, United States
Piedmont HealthcareRecruiting
Atlanta, Georgia, United States
John B Amos Cancer CenterRecruiting
Columbus, Georgia, United States
Rush University Medical CenterRecruiting
Chicago, Illinois, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Renown Regional Medical CenterRecruiting
Reno, Nevada, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long IslandRecruiting
Mineola, New York, United States
NYU Langone HealthRecruiting
New York, New York, United States
Weill Cornell Medical CollegeRecruiting
New York, New York, United States
Rochester General Hospital Infectious DiseaseRecruiting
Rochester, New York, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive CRecruiting
Columbus, Ohio, United States
Providence Cancer Institute Franz ClinicRecruiting
Portland, Oregon, United States
Providence St. Vincent Medical CenterRecruiting
Portland, Oregon, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
Hospital of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
West Penn Allegheny HealthRecruiting
Pittsburgh, Pennsylvania, United States
Local Institution - 0268Withdrawn
Chattanooga, Tennessee, United States
Tennessee OncologyRecruiting
Nashville, Tennessee, United States
Local Institution - 0025Not Yet Recruiting
Houston, Texas, United States
Local Institution - 0173Not Yet Recruiting
San Antonio, Texas, United States
University of Virginia Health SystemRecruiting
Charlottesville, Virginia, United States
Virginia Commonwealth University (Vcu)Recruiting
Richmond, Virginia, United States
Instituto Alexander FlemingRecruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0004Not Yet Recruiting
ABB, Buenos Aires F.D., Argentina
Hospital Privado Universitario de CórdobaRecruiting
Córdoba, Argentina
Local Institution - 0280Not Yet Recruiting
Wilrijk, Antwerpen, Belgium
Local Institution - 0161Not Yet Recruiting
Auderghem, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0022Not Yet Recruiting
Yvoir, Namur, Belgium
Local Institution - 0023Not Yet Recruiting
Ghent, Oost-Vlaanderen, Belgium
Local Institution - 0024Not Yet Recruiting
Sint-Niklaas, Oost-Vlaanderen, Belgium
Arthur J. E. Child Comprehensive Cancer CentreRecruiting
Calgary, Alberta, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Local Institution - 0184Not Yet Recruiting
Chicoutimi, Quebec, Canada
Local Institution - 0185Not Yet Recruiting
Montreal, Quebec, Canada
Local Institution - 0006Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0005Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0007Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0244Not Yet Recruiting
Beijing, Beijing Municipality, China
Local Institution - 0259Not Yet Recruiting
Chongqing, Chongqing Municipality, China
Fujian Cancer HospitalRecruiting
Fuzhou, Fujian, China
Jiangmen Center HospitalRecruiting
Jiangmen, Guangdong, China
Local Institution - 0271Not Yet Recruiting
Anyang, Henan, China
Local Institution - 0261Not Yet Recruiting
Luoyang, Henan, China
Local Institution - 0267Not Yet Recruiting
Jingzhou, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & TechnologyRecruiting
Wuhan, Hubei, China
Local Institution - 0255Not Yet Recruiting
Changsha, Hunan, China
Local Institution - 0256Not Yet Recruiting
Xuzhou, Jiangsu, China
Local Institution - 0247Not Yet Recruiting
Nanchang, Jiangxi, China
Local Institution - 0246Not Yet Recruiting
Changchun, Jilin, China
Local Institution - 0257Not Yet Recruiting
Shenyang, Liaoning, China
Local Institution - 0248Not Yet Recruiting
Jinan, Shandong, China
Local Institution - 0250Not Yet Recruiting
Shanghai, Shanghai Municipality, China
Local Institution - 0249Not Yet Recruiting
Shanghai, Shanghai Municipality, China
Shanxi Cancer HospitalRecruiting
Taiyuan, Shanxi, China
Local Institution - 0252Not Yet Recruiting
Hangzhou, Zhejiang, China
Local Institution - 0251Not Yet Recruiting
Linhai, Zhejiang, China
Local Institution - 0260Not Yet Recruiting
Nanning, China
Local Institution - 0229Not Yet Recruiting
Valledupar, Cesar Department, Colombia
Local Institution - 0228Not Yet Recruiting
Bogotá, Cundinamarca, Colombia
Local Institution - 0227Not Yet Recruiting
Montería, Departamento de Córdoba, Colombia
Local Institution - 0226Not Yet Recruiting
Cali, Valle del Cauca Department, Colombia
Local Institution - 0014Not Yet Recruiting
Strasbourg, Alsace, France
Local Institution - 0017Not Yet Recruiting
Toulouse, Haute-Garonne, France
Local Institution - 0010Not Yet Recruiting
Lille, Hauts-de-France, France
Local Institution - 0018Not Yet Recruiting
La Tronche, Isère, France
Local Institution - 0170Not Yet Recruiting
Saint-Herblain, Loire-Atlantique, France
Local Institution - 0162Not Yet Recruiting
Bron, Rhône, France
Local Institution - 0019Not Yet Recruiting
Villejuif, Val-de-Marne, France
Local Institution - 0012Not Yet Recruiting
Marseille, France
Local Institution - 0278Not Yet Recruiting
Nantes, France
Local Institution - 0011Not Yet Recruiting
Paris, France
Local Institution - 0015Not Yet Recruiting
Paris, France
Local Institution - 0207Not Yet Recruiting
Esslingen am Neckar, Baden-Wurttemberg, Germany
Local Institution - 0238Not Yet Recruiting
Esslingen am Neckar, Baden-Wurttemberg, Germany
Local Institution - 0212Not Yet Recruiting
Stuttgart, Baden-Wurttemberg, Germany
Local Institution - 0236Not Yet Recruiting
Donauwörth, Bavaria, Germany
Local Institution - 0209Not Yet Recruiting
Oldenburg, Lower Saxony, Germany
Local Institution - 0213Not Yet Recruiting
Cologne, North Rhine-Westphalia, Germany
Local Institution - 0208Not Yet Recruiting
Chemnitz, Saxony, Germany
Local Institution - 0274Not Yet Recruiting
Kiel, Schleswig-Holstein, Germany
Local Institution - 0211Not Yet Recruiting
Berlin, Germany
Local Institution - 0215Not Yet Recruiting
Gauting, Germany
Local Institution - 0242Not Yet Recruiting
Hamburg, Germany
Local Institution - 0210Not Yet Recruiting
Heidelberg, Germany
Local Institution - 0239Not Yet Recruiting
Kassel, Germany
Local Institution - 0241Not Yet Recruiting
Ulm, Germany
Local Institution - 0054Not Yet Recruiting
Athens, Attikí, Greece
Local Institution - 0060Not Yet Recruiting
Chaïdári, Attikí, Greece
Local Institution - 0056Not Yet Recruiting
Thessaloniki, Kentrikí Makedonía, Greece
Local Institution - 0062Not Yet Recruiting
Thessaloniki, Thessaloníki, Greece
Local Institution - 0083Withdrawn
Ahmedabad, Gujarat, India
Local Institution - 0073Withdrawn
Ahmedabad, Gujarat, India
Local Institution - 0072Withdrawn
Gurugram, Haryana, India
Local Institution - 0069Not Yet Recruiting
Bengaluru, Karnataka, India
Local Institution - 0077Not Yet Recruiting
Mumbai, Maharashtra, India
Local Institution - 0071Not Yet Recruiting
Mumbai, Maharashtra, India
Local Institution - 0097Not Yet Recruiting
Nagpur, Maharashtra, India
Local Institution - 0070Not Yet Recruiting
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0078Withdrawn
Howrah, West Bengal, India
Local Institution - 0028Not Yet Recruiting
Ravenna, Emilia-Romagna, Italy
Local Institution - 0036Not Yet Recruiting
Aviano, Friuli Venezia Giulia, Italy
Local Institution - 0031Not Yet Recruiting
Orbassano, Piedmont, Italy
Local Institution - 0277Not Yet Recruiting
Candiolo, Torino, Italy
Local Institution - 0137Not Yet Recruiting
Avellino, Italy
Local Institution - 0032Not Yet Recruiting
Milan, Italy
Local Institution - 0034Not Yet Recruiting
Naples, Italy
Local Institution - 0029Not Yet Recruiting
Parma, Italy
Local Institution - 0196Not Yet Recruiting
Nagoya, Aichi-ken, Japan
Local Institution - 0191Not Yet Recruiting
Kashiwa, Chiba, Japan
Local Institution - 0203Not Yet Recruiting
Tōon, Ehime, Japan
Local Institution - 0201Not Yet Recruiting
Kurume, Fukuoka, Japan
Local Institution - 0217Not Yet Recruiting
Sapporo, Hokkaido, Japan
Local Institution - 0199Not Yet Recruiting
Nishinomiya, Hyōgo, Japan
Local Institution - 0193Not Yet Recruiting
Yokohama, Kanagawa, Japan
Local Institution - 0192Not Yet Recruiting
Sendai, Miyagi, Japan
Local Institution - 0200Not Yet Recruiting
Kurashiki, Okayama-ken, Japan
Local Institution - 0198Not Yet Recruiting
Hirakata, Osaka, Japan
Local Institution - 0204Not Yet Recruiting
Ōsaka-sayama, Osaka, Japan
Local Institution - 0194Withdrawn
Ina-machi, Saitama, Japan
Local Institution - 0197Not Yet Recruiting
Hamamatsu, Shizuoka, Japan
Local Institution - 0195Not Yet Recruiting
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
Local Institution - 0202Not Yet Recruiting
Koto-ku, Tokyo, Japan
Local Institution - 0225Not Yet Recruiting
Mexico City, Mexico City, Mexico
Local Institution - 0224Not Yet Recruiting
Oaxaca City, Oaxaca, Mexico
Local Institution - 0222Not Yet Recruiting
Chihuahua City, Mexico
Local Institution - 0223Not Yet Recruiting
Mexico City, Mexico
Local Institution - 0163Not Yet Recruiting
Harderwijk, Gelderland, Netherlands
Local Institution - 0216Not Yet Recruiting
Amsterdam, North Holland, Netherlands
Local Institution - 0164Not Yet Recruiting
Amsterdam, North Holland, Netherlands
Local Institution - 0103Not Yet Recruiting
Drammen, Buskerud, Norway
Local Institution - 0106Not Yet Recruiting
Bergen, Hordaland, Norway
Local Institution - 0105Not Yet Recruiting
Oslo, Norway
Local Institution - 0220Not Yet Recruiting
Lublin, Lublin Voivodeship, Poland
Local Institution - 0231Not Yet Recruiting
Gdynia, Pomeranian Voivodeship, Poland
Local Institution - 0219Not Yet Recruiting
Bydgoszcz, Poland
Local Institution - 0120Withdrawn
Bucharest, Bucharest, Romania
Local Institution - 0123Not Yet Recruiting
Bucharest, Bucharest, Romania
Local Institution - 0132Withdrawn
Florești, Cluj, Romania
Local Institution - 0130Not Yet Recruiting
Craiova, Dolj, Romania
Local Institution - 0115Not Yet Recruiting
Bucharest, Romania
Local Institution - 0133Not Yet Recruiting
Cluj-Napoca, Romania
Local Institution - 0124Not Yet Recruiting
Iași, Romania
Local Institution - 0119Not Yet Recruiting
Iași, Romania
Local Institution - 0263Not Yet Recruiting
Singapore, Singapore
Local Institution - 0262Not Yet Recruiting
Singapore, Singapore
Local Institution - 0089Not Yet Recruiting
Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea
Local Institution - 0043Not Yet Recruiting
Goyang-si, Kyǒnggi-do, South Korea
Local Institution - 0044Not Yet Recruiting
Seongnam, Kyǒnggi-do, South Korea
Local Institution - 0046Not Yet Recruiting
Suwon, Kyǒnggi-do, South Korea
Local Institution - 0095Not Yet Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0045Not Yet Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0092Not Yet Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0042Not Yet Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0218Not Yet Recruiting
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0177Not Yet Recruiting
Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0175Not Yet Recruiting
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0206Not Yet Recruiting
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0176Not Yet Recruiting
Madrid, Madrid, Comunidad de, Spain
Local Institution - 0181Not Yet Recruiting
Majadahonda, Madrid, Comunidad de, Spain
Local Institution - 0178Not Yet Recruiting
Málaga, Spain
Local Institution - 0182Not Yet Recruiting
Seville, Spain
Local Institution - 0180Not Yet Recruiting
Valencia, Spain
Local Institution - 0179Not Yet Recruiting
Zaragoza, Spain
Kantonsspital BadenRecruiting
Baden, Canton of Aargau, Switzerland
Cantonal Hospital St.GallenRecruiting
Sankt Gallen, Canton of St. Gallen, Switzerland
Local Institution - 0189Not Yet Recruiting
Bellinzona, Switzerland
E-Da hospitalRecruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Medical University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Local Institution - 0265Not Yet Recruiting
Bangkok, Bangkok, Thailand
Local Institution - 0272Not Yet Recruiting
Mueng, Changwat Khon Kaen, Thailand
Local Institution - 0264Not Yet Recruiting
Bangkok, Thailand
Local Institution - 0266Not Yet Recruiting
Songkhla, Thailand
Local Institution - 0110Not Yet Recruiting
Glasgow, Glasgow City, United Kingdom
Local Institution - 0061Not Yet Recruiting
London, Kensington and Chelsea, United Kingdom
Local Institution - 0140Not Yet Recruiting
London, London, City of, United Kingdom
Local Institution - 0281Not Yet Recruiting
Sulton, Surrey, United Kingdom