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Recruiting Phase 2/3 NCT07063745

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

Phase 2/3 – combined trial
Conditions: Metastatic Non-small Cell Lung Cancer With MTAP Deletion

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
The purpose of this study is to compare the clinical benefit of the combination of BMS-986504 (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion
Who can participate
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.
Locations 31
Argentina (1)
Local Institution - 0465
Ciudad Autónoma de Buenos Aires , Buenos Aires
NOT_YET_RECRUITING
Australia (1)
Local Institution - 0432
Liverpool , New South Wales
NOT_YET_RECRUITING
Belgium (1)
Antwerp University Hospital
Edegem , Antwerpen
Jo Raskin, Site 0227
Brazil (1)
CEDOES
Vitória , Espírito Santo
Mauricio Pereira, Site 0088
Bulgaria (1)
Local Institution - 0315
Panagyurishte , Pazardzhik
NOT_YET_RECRUITING
China (1)
Local Institution - 0072
Hefei , Anhui
NOT_YET_RECRUITING
Colombia (1)
Local Institution - 0330
Medellín , Antioquia
NOT_YET_RECRUITING
Czech Republic (1)
Fakultni nemocnice Hradec Kralove
Hradec Králové , Hradec Králové
Michal Hrnciarik, Site 0251
Denmark (1)
Local Institution - 0356
Copenhagen , Capital Region
NOT_YET_RECRUITING
France (1)
CHU Bordeaux Haut-Leveque
Pessac , Aquitaine
Remi Veillon, Site 0219
Greece (1)
University Hospital of Patras
Pátrai , Achaḯa
Angelos Koutras, Site 0008
Hong Kong (1)
Queen Mary Hospital
Hksar
Dennis Leung, Site 0285
Hungary (1)
Local Institution - 0290
Gyula , Bekes County
NOT_YET_RECRUITING
India (1)
Local Institution - 0263
Bangalore , Karnataka
NOT_YET_RECRUITING
Israel (1)
Local Institution - 0010
Kfar Saba , Central District
NOT_YET_RECRUITING
Italy (1)
AOU della Campania Luigi Vanvitelli
Naples , Campania
Floriana Morgillo, Site 0105
Japan (1)
Local Institution - 0243
Nagoya , Aichi-ken
NOT_YET_RECRUITING
Malaysia (1)
Local Institution - 0413
Kuala Lumpur , Kuala Lumpur
NOT_YET_RECRUITING
Mexico (1)
Local Institution - 0296
Guadalajara , Jalisco
NOT_YET_RECRUITING
Netherlands (1)
Local Institution - 0445
Veldhoven , North Brabant
NOT_YET_RECRUITING
Norway (1)
Local Institution - 0096
Drammen , Buskerud
NOT_YET_RECRUITING
Poland (1)
Centrum Medyczne Pratia Poznań
Poznan , Greater Poland Voivodeship
Marek Kotlarski, Site 0262
Romania (1)
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
Bucharest , Bucharest
Aurelia Alexandru, Site 0021
South Korea (1)
Local Institution - 0272
Cheongju-si , Chungcheongbuk-do [Chungbuk]
NOT_YET_RECRUITING
Spain (1)
Hospital Universitari Vall d'Hebron
Barcelona , Barcelona [Barcelona]
Enriqueta Felip Font, Site 0116
Sweden (1)
Sahlgrenska Universitetssjukhuset
Gothenburg , Västra Götalands Län [se-14]
Andreas Hallqvist, Site 0097
Taiwan (1)
Chi Mei Hospital - Liouying Branch
Tainan , Tainan
Cheng-Yao Lin, Site 0114
Thailand (1)
Local Institution - 0411
Bangkok
NOT_YET_RECRUITING
Turkey (1)
Local Institution - 0349
Izmir, Karsiyaka , İzmir
NOT_YET_RECRUITING
United Kingdom (1)
Leicester Royal Infirmary
Leicester , Leicestershire
Sean Dulloo, Site 0033
United States (1)
Alaska Oncology and Hematology
Anchorage , Alaska
Steven Liu, Site 0119
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
02.01.2026
Completion date
12.08.2031
Registry ID
NCT07063745
Source
anzctr
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