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Taking people in TaiwanPhase 2/3

Tests navlimetostat with pembrolizumab and chemotherapy in lung cancer with MTAP deletion

Tests navlimetostat plus pembrolizumab and chemotherapy in adults with advanced lung cancer.

Key facts

Who runs it
Bristol-Myers Squibb
Where
Tainan, Taipei, and Taoyuan, TaiwanSee the 5 sitesAlso in 33 other countries, 302 sites
Trial code
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
Status
Recruiting
Phase
Phase 2/3
People taking part
590 people, planned
Started
2 Jan 2026
Expected to end
12 Aug 2031
Type of study
Interventional, 6 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • BMS-986504
  • Pembrolizumab
  • Placebo
  • Cisplatin
  • Carboplatin
  • Pemetrexed
  • Paclitaxel
  • Nab-paclitaxel
Record updated
23 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Taiwan

Also in 33 other countries, 302 sites

  • Chi Mei Hospital - Liouying BranchTainan, TaiwanContact: Cheng-Yao Lin, Site 0114Taking people
  • National Cheng Kung University HospitalTainan, TaiwanContact: Chun-Hui Lee, Site 0111Taking people
  • National Taiwan University HospitalTaipei, TaiwanContact: Chia-Chi Lin, Site 0113Taking people
  • Taipei Medical University HospitalTaipei, TaiwanContact: Chao-Hua Chiu, Site 0115Taking people
  • Chang Gung Medical Foundation-Linkou BranchTaoyuan, TaiwanContact: Chen-Yang Huang, Site 0112Taking people

About the trial

What the trial wants to find out

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

The 6 groups in the trial

  • Arm A: BMS-986504 + Pembrolizumab + ChemotherapyExisting treatment, for comparison

    Treatment: BMS-986504, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, and Nab-paclitaxel

  • Arm B: BMS-986504 + Pembrolizumab + ChemotherapyExisting treatment, for comparison

    Treatment: BMS-986504, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, and Nab-paclitaxel

  • Arm C: Placebo + Pembrolizumab + ChemotherapyPlacebo, for comparison

    Treatment: Pembrolizumab, Placebo, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, and Nab-paclitaxel

  • Arm D: Placebo + Pembrolizumab + ChemotherapyPlacebo, for comparison

    Treatment: Pembrolizumab, Placebo, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, and Nab-paclitaxel

  • Arm E: BMS-986504 + Pembrolizumab + ChemotherapyExisting treatment, for comparison

    Treatment: BMS-986504, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, and Nab-paclitaxel

  • Arm F: Placebo + Pembrolizumab + ChemotherapyPlacebo, for comparison

    Treatment: Pembrolizumab, Placebo, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, and Nab-paclitaxel

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests navlimetostat with pembrolizumab and chemotherapy in lung cancer with MTAP deletionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07063745, who can take part
Record updated
23 October 2026