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)
Launched by BRISTOL-MYERS SQUIBB · Jul 31, 2025
Trial Information
Current as of August 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new drug called Izalontamab Brengitecan to see how well it works compared to a standard chemotherapy treatment (platinum-pemetrexed) for people with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that has an EGFR gene mutation. This study is for patients whose cancer has continued to grow even after they have already tried a certain type of targeted therapy called EGFR TKI therapy, which includes drugs like osimertinib. The goal is to find out if Izalontamab Brengitecan might be a better option after other treatments stop working.
People who may be eligible for this trial are adults between 65 and 74 years old with this type of lung cancer that cannot be cured with surgery or radiation. They must have a confirmed EGFR mutation and their cancer must have worsened despite taking a third-generation EGFR-targeted drug. Participants should also be healthy enough to receive standard chemotherapy with platinum and pemetrexed drugs. If someone has serious health problems, poor organ function, or cancer that has spread to the lining of the brain or spinal cord, they would not be able to join. Those who take part can expect to receive either the new drug or the usual chemotherapy to compare how effective and safe each treatment is. This trial is not yet open for enrollment but aims to offer new hope for people whose lung cancer has become resistant to current therapies.
Gender
ALL
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.
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Napoli, , Italy
Chaidari, , Greece
Orange, California, United States
Edwards, Colorado, United States
Gainesville, Florida, United States
Columbus, Georgia, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Richmond, Virginia, United States
Abb, , Argentina
Cordoba, , Argentina
Auderghem, , Belgium
Yvoir, Namur, Belgium
Gent, Oost Vlaanderen, Belgium
Sint Niklaas, Oost Vlaanderen, Belgium
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Beijing, Beijing, China
Wuhan, Hubei, China
Shenyang, Liaoning, China
Taiyuan, Shanxi, China
Valledupar, Cesar, Colombia
Bogotá, Cundinamarca, Colombia
Montería, , Colombia
Cali, Valle Del Cauca, Colombia
Strasbourg, Alsace, France
Toulouse, Haute Garonne, France
La Tronche, , France
Saint Herblain, Loire Atlantique, France
Lille, Nord Pas De Calais, France
Bron, , France
Villejuif, Val De Marne, France
Marseille, , France
Paris, , France
Paris, , France
Esslingen, , Germany
Esslingen, , Germany
Stuttgart, , Germany
Donauwörth, Bayern, Germany
Oldenburg, Niedersachsen, Germany
Köln, Nordrhein Westfalen, Germany
Chemnitz, Sachsen, Germany
Berlin, , Germany
Gauting, , Germany
Heidelberg, , Germany
Athens, , Greece
Thessaloniki, , Greece
New Delhi, Delhi, India
Ahmedabad, Gujarat, India
Gurugram, Haryana, India
Bengaluru, Karnataka, India
Mumbai, Maharashtra, India
Mumbai, Maharashtra, India
Howrah, West Bengal, India
Ravenna, Emilia Romagna, Italy
Aviano, Friuli Venezia Giulia, Italy
Orbassano, Piemonte, Italy
Avellino, , Italy
Milano, , Italy
Parma, , Italy
Nagoya, Aichi, Japan
Kashiwa, Chiba, Japan
Toon, Ehime, Japan
Kurume, Fukuoka, Japan
Sapporo, Hokkaido, Japan
Nishinomiya, Hyogo, Japan
Yokohama, Kanagawa, Japan
Sendai, Miyagi, Japan
Kurashiki, Okayama, Japan
Hirakata, Osaka, Japan
Osaka Sayama, Osaka, Japan
Ina Machi, Saitama, Japan
Hamamatsu, Shizuoka, Japan
Nagaizumi Cho,Sunto Gun, Shizuoka, Japan
Koto Ku, Tokyo, Japan
Cheongju Si, , Korea, Republic Of
Goyang Si, , Korea, Republic Of
Seongnam, , Korea, Republic Of
Suwon Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Mexico City, Distrito Federal, Mexico
Oaxaca De Juarez, Oaxaca, Mexico
Chihuahua, , Mexico
Mexico City, , Mexico
Harderwijk, Gelderland, Netherlands
Amsterdam, Noord Holland, Netherlands
Amsterdam, Noord Holland, Netherlands
Drammen, Buskerud, Norway
Bergen, Hordaland, Norway
Oslo, , Norway
Lublin, Lubelskie, Poland
Gdynia, Pomorskie, Poland
Bydgoszcz, , Poland
Bucharest, , Romania
Bucharest, , Romania
Florești, Cluj, Romania
Craiova, Dolj, Romania
Bucharest, , Romania
Cluj, , Romania
Iași, , Romania
Iași, , Romania
Singapore, , Singapore
Singapore, , Singapore
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Majadahonda, , Spain
Málaga, , Spain
Sevilla, , Spain
València, , Spain
Zaragoza, , Spain
Baden, Aargau, Switzerland
St.Gallen, Sankt Gallen, Switzerland
Bellinzona, , Switzerland
Kaohsiung, , Taiwan
Taichung, , Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Bangkok, Krung Thep Maha Nakhon, Thailand
Bangkok, , Thailand
Songkhla, , Thailand
Glasgow, Glasgow City, United Kingdom
London, Kensington And Chelsea, United Kingdom
London, , United Kingdom
Atlanta, Georgia, United States
Mineola, New York, United States
Chattanooga, Tennessee, United States
Luoyang, Henan, China
Barcelona, , Spain
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported