A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
Launched by BRISTOL-MYERS SQUIBB · Jul 3, 2025
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment approach for people with a specific type of advanced lung cancer called metastatic non-small cell lung cancer (NSCLC) who have a particular genetic change known as homozygous MTAP deletion. The study will compare the effects of adding a new drug called BMS-986504 to the usual treatment of pembrolizumab (an immunotherapy) and chemotherapy, versus giving a placebo (a treatment with no active drug) along with pembrolizumab and chemotherapy. The goal is to see if the new combination helps patients live longer or improves their cancer control compared to the standard treatment alone.
People who might be eligible for this study are adults with advanced NSCLC that has not been treated before with any systemic cancer therapy and who have the MTAP genetic deletion confirmed by testing. They should have a good overall health status and at least one tumor that can be measured to track response to treatment. Certain patients, such as those with brain metastases causing symptoms or those with other specific genetic mutations that have standard targeted treatments, would not be eligible. Participants in the study can expect to receive either the new drug combination or the standard treatment, and their health and cancer will be closely monitored throughout. This study is currently not recruiting but aims to find better first-line treatment options for this particular group of lung cancer patients.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.
- • Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.
- • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- • Participants must have at least 1 measurable lesion as per RECIST v1.1.
- • Exclusion Criteria
- • Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.
- • Participants must not have symptomatic brain metastases or spinal cord compression.
- • Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC). Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.
- • Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.
- • 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
Barcelona, , Spain
Prabuty, Pomorskie, Poland
Bydgoszcz, , Poland
Ramat Gan, Hamerkaz, Israel
Sao Paulo, , Brazil
Anchorage, Alaska, United States
Tucson, Arizona, United States
Springdale, Arkansas, United States
Fort Lauderdale, Florida, United States
Boise, Idaho, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Scarborough, Maine, United States
Boston, Massachusetts, United States
Hawthorne, New York, United States
Rochester, New York, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Edegem, Antwerpen, Belgium
Hasselt, Limburg, Belgium
Yvoir, Namur, Belgium
Roeselare, West Vlaanderen, Belgium
Brussels, , Belgium
Liège, , Belgium
Vitória, , Brazil
Natal, Rio Grande Do Norte, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Blumenau, Santa Catarina, Brazil
Barretos, , Brazil
Bauru, , Brazil
Campinas, , Brazil
São Caetano Do Sul, , Brazil
São José Do Rio Preto, , Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
Panagyurishte, Pazardzhik, Bulgaria
Haskovo, , Bulgaria
Ruse, , Bulgaria
Stara Zagora, , Bulgaria
Jinan, Shandong, China
Bogotá, Cundinamarca, Colombia
Montería, , Colombia
Hradec Kralove, , Czechia
Olomouc, , Czechia
Copenhagen, Hovedstaden, Denmark
Pessac, Aquitaine, France
Caen, Calvados, France
Dijon, , France
Besançon, Doubs, France
Brest, , France
Toulouse, Haute Garonne, France
Montpellier, , France
Rennes, Ille Et Vilaine, France
Saint Herblain, Loire Atlantique, France
Vandoeuvre Lès Nancy, Meurthe Et Moselle, France
Marseille, , France
Clermont Ferrand, , France
Pierre Bénite, , France
Créteil, Val De Marne, France
Paris, , France
Tours, , France
München, Bayern, Germany
Regensburg, Bayern, Germany
Patras, , Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Thessaloniki, , Greece
Larissa, , Greece
Gyula, , Hungary
Gyöngyös, Heves, Hungary
Farkasgyepu, , Hungary
Budapest, , Hungary
New Delhi, Delhi, India
Bangalore, Karnataka, India
Bengaluru, Karnataka, India
Mumbai, Maharashtra, India
Mumbai, Maharashtra, India
Hyderabad, Telangana, India
Varanasi, Uttar Pradesh, India
Kfar Saba, Hamerkaz, Israel
Afula, Hatsafon, Israel
Haifa, Hatsafon, Israel
Jerusalem, Yerushalayim, Israel
Jerusalem, Yerushalayim, Israel
Napoli, Campania, Italy
Aviano, Friuli Venezia Giulia, Italy
Orbassano, Torino, Italy
Perugia, Umbria, Italy
Bologna, , Italy
Milano, , Italy
Milan, , Italy
Ravenna, , Italy
Nagoya, Aichi, Japan
Kashiwa, Chiba, Japan
Otashi, Gunma, Japan
Sapporo, Hokkaido, Japan
Himeji, Hyogo, Japan
Kobe, Hyogo, Japan
Shiwa Gun Yahaba Cho, Iwate, Japan
Kawasaki, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Nankoku, Kochi, Japan
Matsusaka City, Mie, Japan
Sendai, Miyagi, Japan
Hirakata, Osaka, Japan
Hidaka, Saitama, Japan
Shimotsuga, Tochigi, Japan
Bunkyo Ku, Tokyo, Japan
Ube, Yamaguchi, Japan
Fukuoka, , Japan
Okayama, , Japan
Osaka, , Japan
Cheongju Si, , Korea, Republic Of
Goyang Si, , Korea, Republic Of
Seongnam, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Mexico City, Distrito Federal, Mexico
Mexico City, Distrito Federal, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, , Mexico
Oaxaca De Juarez, Oaxaca, Mexico
Arnhem, , Netherlands
Groningen, , Netherlands
Warsaw, Mazowieckie, Poland
Kraków, , Poland
Poznań, Wielkopolskie, Poland
Bucharest, , Romania
Bucharest, , Romania
Florești, Cluj, Romania
Craiova, Dolj, Romania
Otopeni, Ilfov, Romania
Ploiești, Prahova, Romania
Cluj, , Romania
Cluj, , Romania
Iași, , Romania
Iași, , Romania
Hospitalet, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Majadahonda, , Spain
Málaga, , Spain
Sevilla, , Spain
València, , Spain
Tainan City, Tainan, Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Izmir, Karsiyaka, , Turkey
Adana, , Turkey
Adana, , Turkey
Ankara, , Turkey
Antalya, , Turkey
Bursa, , Turkey
Edirne, , Turkey
London, , United Kingdom
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported