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
- Ballarat Central, Birtinya, Brisbane, Elizabeth Vale, Garran, Hobart, Liverpool, and St Leonards, AustraliaSee the 8 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with metastatic non-small cell lung cancer who have not had treatment for the spread of the disease and whose tumour has an MTAP deletion or MTAP loss.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Metastatic (Stage IV or recurrent) non-small cell lung cancer, confirmed under the microscope. At least 1 measurable tumour (RECIST v1.1). ECOG performance status 0-1.
- Earlier treatment
- No earlier systemic cancer treatment (chemotherapy, immunotherapy, targeted or biological therapy) for metastatic disease. One cycle of standard treatment before randomization is allowed if immediate treatment is needed.
- Biomarker or test result
- Homozygous MTAP deletion or MTAP loss.
Main reasons for not taking part
- Nonsquamous cancer with a targetable gene change that has a standard first-line treatment
- Symptomatic brain metastases or spinal cord compression
- Any earlier systemic therapy for metastatic non-small cell lung cancer
- Problems with the gut that stop swallowing or absorbing a pill without chewing or crushing it
Read by machine on 11 November 2026.
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 Australia
- Grampians HealthBallarat Central, AustraliaTaking people
- Sunshine Coast University HospitalBirtinya, AustraliaTaking people
- Princess Alexandra HospitalBrisbane, AustraliaTaking people
- Lyell McEwin HospitalElizabeth Vale, AustraliaTaking people
- GarranGarran, AustraliaNot yet recruiting
- Royal Hobart HospitalHobart, AustraliaTaking people
- LiverpoolLiverpool, AustraliaNot yet recruiting
- GenesisCare St LeonardsSt Leonards, AustraliaTaking 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.