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)
Non-Small Cell Lung Cancer
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 3
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 850 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Arm A
Not reported in this registry record.
Drug: Iza-bren · Drug: Osimertinib
Arm B
Not reported in this registry record.
Drug: Osimertinib · Drug: Pemetrexed · Drug: Carboplatin · Drug: Cisplatin
Iza-bren DRUG
Specified dose on specified days
Osimertinib DRUG
Specified dose on days
Pemetrexed DRUG
Specified dose on specified days
Carboplatin DRUG
Specified dose on specified days
Cisplatin DRUG
Specified dose on specified days
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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
Not reported in this registry record.
Secondary measures
Overall Survival (OS)
Time frame: Up to approximately 5 years
Not reported in this registry record.
PFS assessed by the investigator as per RECIST v1.1
Time frame: Up to approximately 3 years
Not reported in this registry record.
Second Progression-Free Survival (PFS2) as assessed by the Investigator
Time frame: Up to approximately 5 years
Not reported in this registry record.
Objective Response Rate (ORR) assessed by the BICR as per RECIST v1.1
Time frame: Up to approximately 3 years
Not reported in this registry record.
Objective Response Rate (ORR) assessed by the investigator as per RECIST v1.1
Time frame: Up to approximately 3 years
Not reported in this registry record.
Disease Control Rate (DCR) assessed by the BICR as per RECIST v1.1
Time frame: Up to approximately 3 years
Not reported in this registry record.
Disease Control Rate (DCR) assessed by the investigator as per RECIST v1.1
Time frame: Up to approximately 3 years
Not reported in this registry record.
Duration of Response (DOR) assessed by the BICR as per RECIST v1.1
Time frame: Up to approximately 3 years
Not reported in this registry record.
Duration of Response (DOR) assessed by the investigator as per RECIST v1.1
Time frame: Up to approximately 3 years
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (205)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
205 locations
Local Institution - 0212Beverly Hills, California, United StatesNot yet recruiting
Local Institution - 0504Fullerton, California, United StatesNot yet recruiting
Local Institution - 0357La Jolla, California, United StatesNot yet recruiting
Rocky Mountain Cancer CentersBoulder, Colorado, United StatesRecruiting
Local Institution - 0161Washington D.C., District of Columbia, United StatesNot yet recruiting
Local Institution - 0527Fort Myers, Florida, United StatesNot yet recruiting
Local Institution - 0366Orlando, Florida, United StatesNot yet recruiting
Cancer Care Centers of Brevard - RockledgePalm Bay, Florida, United StatesRecruiting
Local Institution - 0526St. Petersburg, Florida, United StatesNot yet recruiting
Local Institution - 0524West Palm Beach, Florida, United StatesNot yet recruiting
Local Institution - 0185Chicago, Illinois, United StatesNot yet recruiting
Local Institution - 0207Ottawa, Illinois, United StatesNot yet recruiting
Local Institution - 0503Baltimore, Maryland, United StatesNot yet recruiting
Local Institution - 0537Baltimore, Maryland, United StatesNot yet recruiting
Local Institution - 0523Silver Spring, Maryland, United StatesNot yet recruiting
Local Institution - 0521Edina, Minnesota, United StatesNot yet recruiting
Local Institution - 0364Saint Paul, Minnesota, United StatesNot yet recruiting
Washington University School Of MedicineSt Louis, Missouri, United StatesRecruiting
Local Institution - 0402Omaha, Nebraska, United StatesNot yet recruiting
Local Institution - 0290Lebanon, New Hampshire, United StatesNot yet recruiting
Local Institution - 0183New Brunswick, New Jersey, United StatesNot yet recruiting
Local Institution - 0153New York, New York, United StatesNot yet recruiting
Local Institution - 0157The Bronx, New York, United StatesNot yet recruiting
Local Institution - 0385Charlotte, North Carolina, United StatesNot yet recruiting
Local Institution - 0438Sandusky, Ohio, United StatesNot yet recruiting
Local Institution - 0404Portland, Oregon, United StatesNot yet recruiting
Local Institution - 0487Easton, Pennsylvania, United StatesNot yet recruiting
Local Institution - 0200Sioux Falls, South Dakota, United StatesNot yet recruiting
Local Institution - 0199Memphis, Tennessee, United StatesNot yet recruiting
Texas OncologyBeaumont, Texas, United StatesRecruiting
Texas Oncology - DFWDallas, Texas, United StatesRecruiting
Texas Oncology - San AntonioSan Antonio, Texas, United StatesRecruiting
Local Institution - 0411Salt Lake City, Utah, United StatesNot yet recruiting
Local Institution - 0165Fairfax, Virginia, United StatesNot yet recruiting
Local Institution - 0530Fairfax, Virginia, United StatesNot yet recruiting
Shenandoah Oncology, P.C. (Shenandoah Oncology Associates, P.C.)Winchester, Virginia, United StatesRecruiting
Local Institution - 0283Seattle, Washington, United StatesNot yet recruiting
Local Institution - 0502Morgantown, West Virginia, United StatesNot yet recruiting
Local Institution - 0077Mar del Plata, Buenos Aires, ArgentinaNot yet recruiting
Local Institution - 0514Río Cuarto, Córdoba Province, ArgentinaNot yet recruiting
Local Institution - 0086Buenos Aires, ArgentinaNot yet recruiting
Local Institution - 0432Buenos Aires, ArgentinaNot yet recruiting
Local Institution - 0085Buenos Aires, ArgentinaNot yet recruiting
Local Institution - 0078Buenos Aires, ArgentinaNot yet recruiting
Local Institution - 0151Buenos Aires, ArgentinaNot yet recruiting
Local Institution - 0424Camperdown, New South Wales, AustraliaNot yet recruiting
Local Institution - 0439Westmead, New South Wales, AustraliaNot yet recruiting
Local Institution - 0511Greenslopes, Queensland, AustraliaNot yet recruiting
Local Institution - 0492Adelaide, South Australia, AustraliaNot yet recruiting
Local Institution - 0447Clayton, Victoria, AustraliaNot yet recruiting
Local Institution - 0437Murdoch, Western Australia, AustraliaNot yet recruiting
Local Institution - 0253Vitória, Espírito Santo, BrazilNot yet recruiting
Local Institution - 0291Salvador, Estado de Bahia, BrazilNot yet recruiting
Local Institution - 0247Ijuí, Rio Grande do Sul, BrazilNot yet recruiting
Local Institution - 0252Florianópolis, Santa Catarina, BrazilNot yet recruiting
Local Institution - 0244Barretos, São Paulo, BrazilNot yet recruiting
Local Institution - 0249Campinas, São Paulo, BrazilNot yet recruiting
Local Institution - 0261Sorocaba, São Paulo, BrazilNot yet recruiting
Local Institution - 0255Rio de Janeiro, BrazilNot yet recruiting
Local Institution - 0259São Paulo, BrazilNot yet recruiting
Local Institution - 0059Edmonton, Alberta, CanadaNot yet recruiting
Local Institution - 0056Vancouver, British Columbia, CanadaNot yet recruiting
Jewish General HospitalMontreal, Quebec, CanadaRecruiting
Local Institution - 0057Montreal, Quebec, CanadaNot yet recruiting
Local Institution - 0040Regina, Saskatchewan, CanadaNot yet recruiting
Local Institution - 0517Beijing, Beijing Municipality, ChinaNot yet recruiting
Local Institution - 0458Beijing, Beijing Municipality, ChinaNot yet recruiting
Local Institution - 0535Chongqing, Chongqing Municipality, ChinaNot yet recruiting
Local Institution - 0470Chongqing, Chongqing Municipality, ChinaNot yet recruiting
Local Institution - 0493Fuzhou, Fujian, ChinaNot yet recruiting
Local Institution - 0457Fuzhou, Fujian, ChinaNot yet recruiting
Local Institution - 0326Dongguan Shi, Guangdong, ChinaNot yet recruiting
Local Institution - 0331Guangzhou, Guangdong, ChinaNot yet recruiting
Local Institution - 0512Jiangmen, Guangdong, ChinaNot yet recruiting
Local Institution - 0478Zhongshan, Guangdong, ChinaNot yet recruiting
Local Institution - 0321Guilin, Guangxi, ChinaNot yet recruiting
Local Institution - 0328Nanning, Guangxi, ChinaNot yet recruiting
Local Institution - 0505Guiyang, Guizhou, ChinaNot yet recruiting
Local Institution - 0330Haikou, Hainan, ChinaNot yet recruiting
Local Institution - 0322Shijiazhuang, Hebei, ChinaNot yet recruiting
Local Institution - 0343Harbin, Heilongjiang, ChinaNot yet recruiting
Local Institution - 0298Anyang, Henan, ChinaNot yet recruiting
Local Institution - 0341Weihui Shi, Henan, ChinaNot yet recruiting
Local Institution - 0480Zhengzhou, Henan, ChinaNot yet recruiting
Local Institution - 0423Zhengzhou, Henan, ChinaNot yet recruiting
Local Institution - 0483Jingzhou, Hubei, ChinaNot yet recruiting
Local Institution - 0450Wuhan, Hubei, ChinaNot yet recruiting
Local Institution - 0482Changsha, Hunan, ChinaNot yet recruiting
Local Institution - 0467Changsha, Hunan, ChinaNot yet recruiting
Local Institution - 0536Changsha, Hunan, ChinaNot yet recruiting
Local Institution - 0306Changsha Shi, Hunan, ChinaNot yet recruiting
Local Institution - 0531Lianyungang, Jiangsu, ChinaNot yet recruiting
Local Institution - 0347Nanjing, Jiangsu, ChinaNot yet recruiting
Local Institution - 0332Shenyang, Liaoning, ChinaNot yet recruiting
Local Institution - 0464Xi'an, Shaanxi, ChinaWithdrawn
Local Institution - 0479Binzhou, Shandong, ChinaNot yet recruiting
Local Institution - 0455Jinan, Shandong, ChinaNot yet recruiting
Local Institution - 0413Linyi, Shandong, ChinaNot yet recruiting
Local Institution - 0469Weifang Shi, Shandong, ChinaNot yet recruiting
Local Institution - 0319Shanghai Shi, Shanghai Municipality, ChinaNot yet recruiting
Local Institution - 0316Taiyuan, Shanxi, ChinaNot yet recruiting
Local Institution - 0463Taiyuan, Shanxi, ChinaNot yet recruiting
Local Institution - 0456Chengdu, Sichuan, ChinaNot yet recruiting
Local Institution - 0471Chengdu, Sichuan, ChinaWithdrawn
Local Institution - 0534Chengdu, Sichuan, ChinaNot yet recruiting
Local Institution - 0320Dazhou Shi, Sichuan, ChinaNot yet recruiting
Local Institution - 0472Yibin, Sichuan, ChinaNot yet recruiting
Local Institution - 0452Tianjin, Tianjin Municipality, ChinaNot yet recruiting
Local Institution - 0312Hangzhou, Zhejiang, ChinaNot yet recruiting
Local Institution - 0074Marseille, Bouches-Du-Rhône, FranceNot yet recruiting
Local Institution - 0063Dijon, Côte-D'Or, FranceNot yet recruiting
Local Institution - 0075Nantes, Loire Atlantique, FranceNot yet recruiting
Local Institution - 0064La Tronche, Nan, FranceNot yet recruiting
Local Institution - 0116Lyon, Nan, FranceNot yet recruiting
Local Institution - 0109Paris, Nan, FranceNot yet recruiting
Local Institution - 0062Bron, Rhône, FranceNot yet recruiting
Local Institution - 0069Villejuif, Val-De-Marne, FranceNot yet recruiting
Local Institution - 0073Brest, FranceNot yet recruiting
Local Institution - 0066Caen, FranceNot yet recruiting
Local Institution - 0070Toulouse, FranceNot yet recruiting
Local Institution - 0071Paris, Île-de-France Region, FranceNot yet recruiting
Local Institution - 0112Gerlingen, Baden-Wurttemberg, GermanyNot yet recruiting
Local Institution - 0001Munich, Bavaria, GermanyNot yet recruiting
Local Institution - 0105Regensburg, Bavaria, GermanyNot yet recruiting
Local Institution - 0446Frankfurt am Main, Hesse, GermanyNot yet recruiting
Local Institution - 0106Oldenburg, Lower Saxony, GermanyNot yet recruiting
Local Institution - 0100Cologne, North Rhine-Westphalia, GermanyNot yet recruiting
Local Institution - 0243Dortmund, North Rhine-Westphalia, GermanyNot yet recruiting
Local Institution - 0104Essen, North Rhine-Westphalia, GermanyNot yet recruiting
Local Institution - 0117Hemer, North Rhine-Westphalia, GermanyNot yet recruiting
Local Institution - 0101Münster, North Rhine-Westphalia, GermanyNot yet recruiting
Local Institution - 0103Dresden, Saxony, GermanyNot yet recruiting
Local Institution - 0412Leipzig, Saxony, GermanyNot yet recruiting
Local Institution - 0108Großhansdorf, Schleswig-Holstein, GermanyNot yet recruiting
Local Institution - 0239Lübeck, Schleswig-Holstein, GermanyNot yet recruiting
Local Institution - 0445Giessen, GermanyNot yet recruiting
Local Institution - 0225Vadodara, Gujarat, IndiaNot yet recruiting
Local Institution - 0444Badsa, Haryana, IndiaNot yet recruiting
Local Institution - 0337Gurgaon, Haryana, IndiaNot yet recruiting
Local Institution - 0436Belagavi, Karnataka, IndiaNot yet recruiting
Local Institution - 0215Pune, Maharashtra, IndiaNot yet recruiting
Local Institution - 0233Mohali, Punjab, IndiaNot yet recruiting
Local Institution - 0222Chennai, Tamil Nadu, IndiaNot yet recruiting
Local Institution - 0093Bergamo, BG, ItalyNot yet recruiting
Local Institution - 0236Meldola, Forli-Cesena, ItalyNot yet recruiting
Local Institution - 0094Candiolo, Turin, ItalyNot yet recruiting
Local Institution - 0289Brescia, ItalyNot yet recruiting
Local Institution - 0089Milan, ItalyNot yet recruiting
Local Institution - 0087Milan, ItalyNot yet recruiting
Local Institution - 0238Milan, ItalyNot yet recruiting
Local Institution - 0091Pavia, ItalyNot yet recruiting
Local Institution - 0088Verona, ItalyNot yet recruiting
Local Institution - 0262Nagoya, Aichi-ken, JapanNot yet recruiting
Local Institution - 0128Toon-Shi, Ehime, JapanNot yet recruiting
Local Institution - 0136Kurume-Shi, Fukuoka, JapanNot yet recruiting
Local Institution - 0121Yokohama, Kanagawa, JapanNot yet recruiting
Local Institution - 0122Sendai, Miyagi, JapanNot yet recruiting
Local Institution - 0433Okayama, Okayama-ken, JapanNot yet recruiting
Local Institution - 0125Hirakata-Shi, Osaka, JapanNot yet recruiting
Local Institution - 0129Osakasayama-Shi, Osaka, JapanNot yet recruiting
Local Institution - 0141Hamamatsu, Shizuoka, JapanNot yet recruiting
Local Institution - 0137Chūōku, Tokyo-To, JapanNot yet recruiting
Local Institution - 0414Kōtoku, Tokyo-To, JapanNot yet recruiting
Local Institution - 0140Cheongju-si, Chungcheongbuk-do [Chungbuk], South KoreaNot yet recruiting
Local Institution - 0138Buk-Gu, Daegu, South KoreaNot yet recruiting
Local Institution - 0506Dalseo, Daegu, South KoreaNot yet recruiting
Local Institution - 0127Goyang-si, Gyeonggi-do, South KoreaNot yet recruiting
Local Institution - 0133Seongnam-si, Gyeonggi-do, South KoreaNot yet recruiting
Local Institution - 0134Hwasun-Gun, Jeollanam-do, South KoreaNot yet recruiting
Local Institution - 0124Seocho -Gu, Seoul, South KoreaNot yet recruiting
Local Institution - 0123Songpa-Gu, Seoul, South KoreaNot yet recruiting
Local Institution - 0131Seoul, Seoul-teukbyeolsi [Seoul], South KoreaNot yet recruiting
Local Institution - 0139Gyeongsangnam-do, South KoreaNot yet recruiting
Local Institution - 0135Seoul, South KoreaNot yet recruiting
Local Institution - 0126Seoul, South KoreaNot yet recruiting
Local Institution - 0143Majadahonda, Madrid, SpainNot yet recruiting
Local Institution - 0147Seville, Seville, SpainNot yet recruiting
Local Institution - 0242A Coruña, SpainNot yet recruiting
Local Institution - 0144Jaén, SpainNot yet recruiting
Local Institution - 0226Jaén, SpainWithdrawn
Local Institution - 0149Jerez de la Frontera, SpainNot yet recruiting
Local Institution - 0148Madrid, SpainNot yet recruiting
Local Institution - 0150Málaga, SpainNot yet recruiting
Local Institution - 0241Valencia, SpainNot yet recruiting
Local Institution - 0229Kaohsiung City, Kaohsiung, TaiwanNot yet recruiting
Local Institution - 0230New Taipei City, New Taipei, TaiwanNot yet recruiting
Local Institution - 0223Taipei City, Taipei, TaiwanNot yet recruiting
Local Institution - 0221Taoyuan City, Taoyuan, TaiwanNot yet recruiting
Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanRecruiting
Local Institution - 0418Taichung, TaiwanNot yet recruiting
China Medical University HospitalTaichung, TaiwanRecruiting
Local Institution - 0420Tainan, TaiwanNot yet recruiting
Local Institution - 0275Bangkok, Bangkok, ThailandNot yet recruiting
Local Institution - 0263Din Daeng, Bangkok, ThailandNot yet recruiting
Local Institution - 0021Sur, Diyarbakır, Turkey (Türkiye)Not yet recruiting
Local Institution - 0265Pendik, Istanbul, Turkey (Türkiye)Not yet recruiting
Local Institution - 0014Adana, Turkey (Türkiye)Not yet recruiting
Local Institution - 0019Adana, Turkey (Türkiye)Not yet recruiting
Local Institution - 0008Ankara, Turkey (Türkiye)Not yet recruiting
Local Institution - 0003Ankara, Turkey (Türkiye)Not yet recruiting
Local Institution - 0015Antalya, Turkey (Türkiye)Not yet recruiting
Local Institution - 0041Istanbul, Turkey (Türkiye)Not yet recruiting
Local Institution - 0039Istanbul, Turkey (Türkiye)Not yet recruiting
Local Institution - 0050Izmir, Turkey (Türkiye)Not yet recruiting
Local Institution - 0037Izmir, Turkey (Türkiye)Not yet recruiting
Study team and timeline
- Lead sponsor
- Bristol-Myers Squibb
- Study start
- Sep 8, 2026 Actual
- Primary completion
- Dec 30, 2031 Estimated
- Study completion
- Dec 30, 2031 Estimated
- First posted
- Jul 2, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
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
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026
