Tests navlimetostat with pembrolizumab and chemotherapy in lung cancer with MTAP deletion
Tests navlimetostat plus pembrolizumab and chemotherapy in adults with advanced lung cancer.
Plain-language title generated from the registry record
Registry title: A Study to Compare the Combination of Navlimetostat (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
Key facts
- Where
- Barretos, Bauru, Blumenau, Campinas, Fortaleza, Natal, Porto Alegre, Rio de Janeiro, Santa Cruz do Sul, São Caetano do Sul, São José do Rio Preto, São Paulo, and Vitória, BrazilSee the 15 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- Can you look after yourself and are you up and about most of the day?
- Has your cancer spread to the brain?
Source: NCT07063745, who can take part
Where in Brazil
- Fundação Pio XII - Hospital de Câncer de BarretosBarretos, BrazilTaking people
- NAIC - Instituto do CâncerBauru, BrazilTaking people
- Clínica de Oncologia ReichowBlumenau, BrazilTaking people
- Centro de Pesquisa Sao LucasCampinas, BrazilTaking people
- PronutrirFortaleza, BrazilTaking people
- Liga Norte Riograndense Contra o CancerNatal, BrazilTaking people
- Hospital Nossa Senhora da ConceiçãoPorto Alegre, BrazilTaking people
- Unimed Porto AlegrePorto Alegre, BrazilTaking people
- Instituto Nacional de Câncer - INCARio de Janeiro, BrazilTaking people
- Instituto de Oncologia Saint GallenSanta Cruz do Sul, BrazilTaking people
- Centro de Oncologia - CEON+ - Unidade São Caetano do SulSão Caetano do Sul, BrazilTaking people
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio PretoSão José do Rio Preto, BrazilTaking people
- A.C. Camargo Cancer CenterSão Paulo, BrazilTaking people
- Icesp - Instituto Do Câncer Do Estado de São PauloSão Paulo, BrazilTaking people
- CEDOESVitória, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07063745EU 2025-521511-40-00
- Record updated
- 23 October 2026
- Original description
The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (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 deletionRead full original descriptionShow less
A Randomized Phase 2/3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (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
Inclusion: 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: 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 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; Participants must not have symptomatic brain metastases or spinal cord compression; Other protocol-defined Inclusion/Exclusion criteria apply.