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Back to study searchNCT07680790
RecruitingNCT07680790ClinicalTrials.gov record

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

THE QUICK READ

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.
Understand screening

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

Prepare your questions

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.

No results are flagged as posted.

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
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Local Institution - 0504Fullerton, California, United StatesNot yet recruiting
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Local Institution - 0357La Jolla, California, United StatesNot yet recruiting
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Rocky Mountain Cancer CentersBoulder, Colorado, United StatesRecruiting
Hossein Maymani, Site 0520CONTACT000-000-0000
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Local Institution - 0161Washington D.C., District of Columbia, United StatesNot yet recruiting
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Local Institution - 0527Fort Myers, Florida, United StatesNot yet recruiting
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Local Institution - 0366Orlando, Florida, United StatesNot yet recruiting
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Cancer Care Centers of Brevard - RockledgePalm Bay, Florida, United StatesRecruiting
Venkat Pavan Kancharla, Site 0519CONTACT111-111-1111
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Local Institution - 0526St. Petersburg, Florida, United StatesNot yet recruiting
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Local Institution - 0524West Palm Beach, Florida, United StatesNot yet recruiting
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Local Institution - 0185Chicago, Illinois, United StatesNot yet recruiting
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Local Institution - 0207Ottawa, Illinois, United StatesNot yet recruiting
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Local Institution - 0503Baltimore, Maryland, United StatesNot yet recruiting
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Local Institution - 0537Baltimore, Maryland, United StatesNot yet recruiting
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Local Institution - 0523Silver Spring, Maryland, United StatesNot yet recruiting
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Local Institution - 0521Edina, Minnesota, United StatesNot yet recruiting
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Local Institution - 0364Saint Paul, Minnesota, United StatesNot yet recruiting
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Washington University School Of MedicineSt Louis, Missouri, United StatesRecruiting
Christine Auberle, Site 0403CONTACT
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Local Institution - 0402Omaha, Nebraska, United StatesNot yet recruiting
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Local Institution - 0290Lebanon, New Hampshire, United StatesNot yet recruiting
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Local Institution - 0183New Brunswick, New Jersey, United StatesNot yet recruiting
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Local Institution - 0153New York, New York, United StatesNot yet recruiting
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Local Institution - 0157The Bronx, New York, United StatesNot yet recruiting
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Local Institution - 0385Charlotte, North Carolina, United StatesNot yet recruiting
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Local Institution - 0438Sandusky, Ohio, United StatesNot yet recruiting
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Local Institution - 0404Portland, Oregon, United StatesNot yet recruiting
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Local Institution - 0487Easton, Pennsylvania, United StatesNot yet recruiting
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Local Institution - 0200Sioux Falls, South Dakota, United StatesNot yet recruiting
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Local Institution - 0199Memphis, Tennessee, United StatesNot yet recruiting
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Texas OncologyBeaumont, Texas, United StatesRecruiting
Ashok Malani, Site 0522CONTACT713-792-2740
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Texas Oncology - DFWDallas, Texas, United StatesRecruiting
Kartik Konduri, Site 0525CONTACT214-370-1000
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Texas Oncology - San AntonioSan Antonio, Texas, United StatesRecruiting
Krishna Alluri, Site 0529CONTACT210-656-7177
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Local Institution - 0411Salt Lake City, Utah, United StatesNot yet recruiting
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Local Institution - 0165Fairfax, Virginia, United StatesNot yet recruiting
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Local Institution - 0530Fairfax, Virginia, United StatesNot yet recruiting
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Shenandoah Oncology, P.C. (Shenandoah Oncology Associates, P.C.)Winchester, Virginia, United StatesRecruiting
Michael McCusker Jr., Site 0528CONTACT
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Local Institution - 0283Seattle, Washington, United StatesNot yet recruiting
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Local Institution - 0502Morgantown, West Virginia, United StatesNot yet recruiting
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Local Institution - 0077Mar del Plata, Buenos Aires, ArgentinaNot yet recruiting
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Local Institution - 0514Río Cuarto, Córdoba Province, ArgentinaNot yet recruiting
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Local Institution - 0086Buenos Aires, ArgentinaNot yet recruiting
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Local Institution - 0432Buenos Aires, ArgentinaNot yet recruiting
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Local Institution - 0085Buenos Aires, ArgentinaNot yet recruiting
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Local Institution - 0078Buenos Aires, ArgentinaNot yet recruiting
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Local Institution - 0151Buenos Aires, ArgentinaNot yet recruiting
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Local Institution - 0424Camperdown, New South Wales, AustraliaNot yet recruiting
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Local Institution - 0439Westmead, New South Wales, AustraliaNot yet recruiting
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Local Institution - 0511Greenslopes, Queensland, AustraliaNot yet recruiting
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Local Institution - 0492Adelaide, South Australia, AustraliaNot yet recruiting
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Local Institution - 0447Clayton, Victoria, AustraliaNot yet recruiting
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Local Institution - 0437Murdoch, Western Australia, AustraliaNot yet recruiting
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Local Institution - 0253Vitória, Espírito Santo, BrazilNot yet recruiting
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Local Institution - 0291Salvador, Estado de Bahia, BrazilNot yet recruiting
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Local Institution - 0247Ijuí, Rio Grande do Sul, BrazilNot yet recruiting
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Local Institution - 0252Florianópolis, Santa Catarina, BrazilNot yet recruiting
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Local Institution - 0244Barretos, São Paulo, BrazilNot yet recruiting
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Local Institution - 0249Campinas, São Paulo, BrazilNot yet recruiting
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Local Institution - 0261Sorocaba, São Paulo, BrazilNot yet recruiting
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Local Institution - 0255Rio de Janeiro, BrazilNot yet recruiting
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Local Institution - 0259São Paulo, BrazilNot yet recruiting
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Local Institution - 0059Edmonton, Alberta, CanadaNot yet recruiting
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Local Institution - 0056Vancouver, British Columbia, CanadaNot yet recruiting
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Jewish General HospitalMontreal, Quebec, CanadaRecruiting
Jennifer Friedmann, Site 0058CONTACT514340822224915
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Local Institution - 0057Montreal, Quebec, CanadaNot yet recruiting
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Local Institution - 0040Regina, Saskatchewan, CanadaNot yet recruiting
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Local Institution - 0517Beijing, Beijing Municipality, ChinaNot yet recruiting
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Local Institution - 0458Beijing, Beijing Municipality, ChinaNot yet recruiting
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Local Institution - 0535Chongqing, Chongqing Municipality, ChinaNot yet recruiting
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Local Institution - 0470Chongqing, Chongqing Municipality, ChinaNot yet recruiting
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Local Institution - 0493Fuzhou, Fujian, ChinaNot yet recruiting
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Local Institution - 0457Fuzhou, Fujian, ChinaNot yet recruiting
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Local Institution - 0326Dongguan Shi, Guangdong, ChinaNot yet recruiting
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Local Institution - 0331Guangzhou, Guangdong, ChinaNot yet recruiting
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Local Institution - 0512Jiangmen, Guangdong, ChinaNot yet recruiting
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Local Institution - 0478Zhongshan, Guangdong, ChinaNot yet recruiting
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Local Institution - 0321Guilin, Guangxi, ChinaNot yet recruiting
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Local Institution - 0328Nanning, Guangxi, ChinaNot yet recruiting
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Local Institution - 0505Guiyang, Guizhou, ChinaNot yet recruiting
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Local Institution - 0330Haikou, Hainan, ChinaNot yet recruiting
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Local Institution - 0322Shijiazhuang, Hebei, ChinaNot yet recruiting
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Local Institution - 0343Harbin, Heilongjiang, ChinaNot yet recruiting
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Local Institution - 0298Anyang, Henan, ChinaNot yet recruiting
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Local Institution - 0341Weihui Shi, Henan, ChinaNot yet recruiting
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Local Institution - 0480Zhengzhou, Henan, ChinaNot yet recruiting
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Local Institution - 0423Zhengzhou, Henan, ChinaNot yet recruiting
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Local Institution - 0483Jingzhou, Hubei, ChinaNot yet recruiting
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Local Institution - 0450Wuhan, Hubei, ChinaNot yet recruiting
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Local Institution - 0482Changsha, Hunan, ChinaNot yet recruiting
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Local Institution - 0467Changsha, Hunan, ChinaNot yet recruiting
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Local Institution - 0536Changsha, Hunan, ChinaNot yet recruiting
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Local Institution - 0306Changsha Shi, Hunan, ChinaNot yet recruiting
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Local Institution - 0531Lianyungang, Jiangsu, ChinaNot yet recruiting
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Local Institution - 0347Nanjing, Jiangsu, ChinaNot yet recruiting
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Local Institution - 0332Shenyang, Liaoning, ChinaNot yet recruiting
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Local Institution - 0464Xi'an, Shaanxi, ChinaWithdrawn
Local Institution - 0479Binzhou, Shandong, ChinaNot yet recruiting
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Local Institution - 0455Jinan, Shandong, ChinaNot yet recruiting
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Local Institution - 0413Linyi, Shandong, ChinaNot yet recruiting
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Local Institution - 0469Weifang Shi, Shandong, ChinaNot yet recruiting
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Local Institution - 0319Shanghai Shi, Shanghai Municipality, ChinaNot yet recruiting
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Local Institution - 0316Taiyuan, Shanxi, ChinaNot yet recruiting
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Local Institution - 0463Taiyuan, Shanxi, ChinaNot yet recruiting
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Local Institution - 0456Chengdu, Sichuan, ChinaNot yet recruiting
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Local Institution - 0471Chengdu, Sichuan, ChinaWithdrawn
Local Institution - 0534Chengdu, Sichuan, ChinaNot yet recruiting
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Local Institution - 0320Dazhou Shi, Sichuan, ChinaNot yet recruiting
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Local Institution - 0472Yibin, Sichuan, ChinaNot yet recruiting
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Local Institution - 0452Tianjin, Tianjin Municipality, ChinaNot yet recruiting
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Local Institution - 0312Hangzhou, Zhejiang, ChinaNot yet recruiting
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Local Institution - 0074Marseille, Bouches-Du-Rhône, FranceNot yet recruiting
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Local Institution - 0063Dijon, Côte-D'Or, FranceNot yet recruiting
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Local Institution - 0075Nantes, Loire Atlantique, FranceNot yet recruiting
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Local Institution - 0064La Tronche, Nan, FranceNot yet recruiting
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Local Institution - 0116Lyon, Nan, FranceNot yet recruiting
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Local Institution - 0109Paris, Nan, FranceNot yet recruiting
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Local Institution - 0062Bron, Rhône, FranceNot yet recruiting
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Local Institution - 0069Villejuif, Val-De-Marne, FranceNot yet recruiting
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Local Institution - 0073Brest, FranceNot yet recruiting
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Local Institution - 0066Caen, FranceNot yet recruiting
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Local Institution - 0070Toulouse, FranceNot yet recruiting
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Local Institution - 0071Paris, Île-de-France Region, FranceNot yet recruiting
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Local Institution - 0112Gerlingen, Baden-Wurttemberg, GermanyNot yet recruiting
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Local Institution - 0001Munich, Bavaria, GermanyNot yet recruiting
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Local Institution - 0105Regensburg, Bavaria, GermanyNot yet recruiting
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Local Institution - 0446Frankfurt am Main, Hesse, GermanyNot yet recruiting
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Local Institution - 0106Oldenburg, Lower Saxony, GermanyNot yet recruiting
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Local Institution - 0100Cologne, North Rhine-Westphalia, GermanyNot yet recruiting
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Local Institution - 0243Dortmund, North Rhine-Westphalia, GermanyNot yet recruiting
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Local Institution - 0104Essen, North Rhine-Westphalia, GermanyNot yet recruiting
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Local Institution - 0117Hemer, North Rhine-Westphalia, GermanyNot yet recruiting
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Local Institution - 0101Münster, North Rhine-Westphalia, GermanyNot yet recruiting
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Local Institution - 0103Dresden, Saxony, GermanyNot yet recruiting
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Local Institution - 0412Leipzig, Saxony, GermanyNot yet recruiting
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Local Institution - 0108Großhansdorf, Schleswig-Holstein, GermanyNot yet recruiting
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Local Institution - 0239Lübeck, Schleswig-Holstein, GermanyNot yet recruiting
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Local Institution - 0445Giessen, GermanyNot yet recruiting
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Local Institution - 0225Vadodara, Gujarat, IndiaNot yet recruiting
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Local Institution - 0444Badsa, Haryana, IndiaNot yet recruiting
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Local Institution - 0337Gurgaon, Haryana, IndiaNot yet recruiting
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Local Institution - 0436Belagavi, Karnataka, IndiaNot yet recruiting
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Local Institution - 0215Pune, Maharashtra, IndiaNot yet recruiting
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Local Institution - 0233Mohali, Punjab, IndiaNot yet recruiting
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Local Institution - 0222Chennai, Tamil Nadu, IndiaNot yet recruiting
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Local Institution - 0093Bergamo, BG, ItalyNot yet recruiting
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Local Institution - 0236Meldola, Forli-Cesena, ItalyNot yet recruiting
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Local Institution - 0094Candiolo, Turin, ItalyNot yet recruiting
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Local Institution - 0289Brescia, ItalyNot yet recruiting
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Local Institution - 0089Milan, ItalyNot yet recruiting
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Local Institution - 0087Milan, ItalyNot yet recruiting
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Local Institution - 0238Milan, ItalyNot yet recruiting
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Local Institution - 0091Pavia, ItalyNot yet recruiting
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Local Institution - 0088Verona, ItalyNot yet recruiting
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Local Institution - 0262Nagoya, Aichi-ken, JapanNot yet recruiting
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Local Institution - 0128Toon-Shi, Ehime, JapanNot yet recruiting
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Local Institution - 0136Kurume-Shi, Fukuoka, JapanNot yet recruiting
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Local Institution - 0121Yokohama, Kanagawa, JapanNot yet recruiting
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Local Institution - 0122Sendai, Miyagi, JapanNot yet recruiting
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Local Institution - 0433Okayama, Okayama-ken, JapanNot yet recruiting
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Local Institution - 0125Hirakata-Shi, Osaka, JapanNot yet recruiting
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Local Institution - 0129Osakasayama-Shi, Osaka, JapanNot yet recruiting
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Local Institution - 0141Hamamatsu, Shizuoka, JapanNot yet recruiting
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Local Institution - 0137Chūōku, Tokyo-To, JapanNot yet recruiting
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Local Institution - 0414Kōtoku, Tokyo-To, JapanNot yet recruiting
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Local Institution - 0140Cheongju-si, Chungcheongbuk-do [Chungbuk], South KoreaNot yet recruiting
Site 0140CONTACT
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Local Institution - 0138Buk-Gu, Daegu, South KoreaNot yet recruiting
Site 0138CONTACT
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Local Institution - 0506Dalseo, Daegu, South KoreaNot yet recruiting
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Local Institution - 0127Goyang-si, Gyeonggi-do, South KoreaNot yet recruiting
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Local Institution - 0133Seongnam-si, Gyeonggi-do, South KoreaNot yet recruiting
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Local Institution - 0134Hwasun-Gun, Jeollanam-do, South KoreaNot yet recruiting
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Local Institution - 0124Seocho -Gu, Seoul, South KoreaNot yet recruiting
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Local Institution - 0123Songpa-Gu, Seoul, South KoreaNot yet recruiting
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Local Institution - 0131Seoul, Seoul-teukbyeolsi [Seoul], South KoreaNot yet recruiting
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Local Institution - 0139Gyeongsangnam-do, South KoreaNot yet recruiting
Site 0139CONTACT
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Local Institution - 0135Seoul, South KoreaNot yet recruiting
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Local Institution - 0126Seoul, South KoreaNot yet recruiting
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Local Institution - 0143Majadahonda, Madrid, SpainNot yet recruiting
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Local Institution - 0147Seville, Seville, SpainNot yet recruiting
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Local Institution - 0242A Coruña, SpainNot yet recruiting
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Local Institution - 0144Jaén, SpainNot yet recruiting
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Local Institution - 0226Jaén, SpainWithdrawn
Local Institution - 0149Jerez de la Frontera, SpainNot yet recruiting
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Local Institution - 0148Madrid, SpainNot yet recruiting
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Local Institution - 0150Málaga, SpainNot yet recruiting
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Local Institution - 0241Valencia, SpainNot yet recruiting
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Local Institution - 0229Kaohsiung City, Kaohsiung, TaiwanNot yet recruiting
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Local Institution - 0230New Taipei City, New Taipei, TaiwanNot yet recruiting
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Local Institution - 0223Taipei City, Taipei, TaiwanNot yet recruiting
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Local Institution - 0221Taoyuan City, Taoyuan, TaiwanNot yet recruiting
Site 0221CONTACT
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Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanRecruiting
Jen-Yu Hung, Site 0227CONTACT+888-7-3121101-5651
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Local Institution - 0418Taichung, TaiwanNot yet recruiting
Site 0418CONTACT
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China Medical University HospitalTaichung, TaiwanRecruiting
Local Institution - 0420Tainan, TaiwanNot yet recruiting
Site 0420CONTACT
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Local Institution - 0275Bangkok, Bangkok, ThailandNot yet recruiting
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Local Institution - 0263Din Daeng, Bangkok, ThailandNot yet recruiting
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Local Institution - 0021Sur, Diyarbakır, Turkey (Türkiye)Not yet recruiting
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Local Institution - 0265Pendik, Istanbul, Turkey (Türkiye)Not yet recruiting
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Local Institution - 0014Adana, Turkey (Türkiye)Not yet recruiting
Site 0014CONTACT
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Local Institution - 0019Adana, Turkey (Türkiye)Not yet recruiting
Site 0019CONTACT
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Local Institution - 0008Ankara, Turkey (Türkiye)Not yet recruiting
Site 0008CONTACT
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Local Institution - 0003Ankara, Turkey (Türkiye)Not yet recruiting
Site 0003CONTACT
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Local Institution - 0015Antalya, Turkey (Türkiye)Not yet recruiting
Site 0015CONTACT
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Local Institution - 0041Istanbul, Turkey (Türkiye)Not yet recruiting
Site 0041CONTACT
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Local Institution - 0039Istanbul, Turkey (Türkiye)Not yet recruiting
Site 0039CONTACT
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Local Institution - 0050Izmir, Turkey (Türkiye)Not yet recruiting
Site 0050CONTACT
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Local Institution - 0037Izmir, Turkey (Türkiye)Not yet recruiting
Site 0037CONTACT
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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

BMS Clinical Trials Contact Center www.BMSClinicalTrials.comCONTACTClinical.Trials@bms.com855-907-3286
First line of the email MUST contain NCT # and Site #.CONTACT
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

A HUMAN NEXT STEP

Ask Wellness Clinical Research

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Sending a question does not enroll you in a trial.

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