A Phase 2/3 interventional study of BMS-986504 and Pembrolizumab in Metastatic Non-small Cell Lung Cancer With MTAP Deletion, sponsored by Bristol-Myers Squibb. Recruiting at 321 sites in 34 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Bristol-Myers Squibb · Phase 2/3, Interventional, and Treatment
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Among 40 studies in Lung Neoplasms by Bristol-Myers Squibb — 6 open to participants now, 9 under way, 2 of them phase 3. Lung Neoplasms · Bristol-Myers Squibb.
Among the 40 studies in Lung Neoplasms by Bristol-Myers Squibb, this one is the 6th largest by planned enrollment of the 34 interventional ones that give a count, is one of 2 that started in 2026, is one of 2 in phase 2/3, and was the 37th registered.
5,423 studies on the registry are indexed under Lung Neoplasms; 1,345 are open to participants now.
Browse Lung Neoplasms studies →6 of the 40 studies in Lung Neoplasms by Bristol-Myers Squibb are open now, in 12 countries. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in United States, Belgium, Canada and 10 more countries
Ages 18+
Bristol-Myers Squibb · Sites in United States, Canada, Spain
Ages 18+
Bristol-Myers Squibb · Sites in United States, Argentina, Belgium and 22 more countries
Ages 18+
Bristol-Myers Squibb · Sites in United States, Australia, Canada and 7 more countries
Ages 18+
Turning Point Therapeutics, Inc. · Sites in United States, Australia, Belgium and 16 more countries
Ages 12+
By country, each count listing its studies:
Of the 995 Lung Neoplasms studies recruiting now, 682 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 14 · Phase 3 11 · Phase 4 2
First in 2003; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 590 is above the median of 60 across 3,657 interventional studies indexed under Lung Neoplasms.
Median enrollment 220 across the 34 interventional studies, 977 across the 6 observational. Of the 29 that completed or were terminated, 14 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
Bristol-Myers Squibb is the lead sponsor of 1,560 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 40 studies in Lung Neoplasms by Bristol-Myers Squibb, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BMS-986504 · Drug: Pembrolizumab · Drug: Cisplatin · Drug: Carboplatin · Drug: Pemetrexed · Drug: Paclitaxel · Drug: Nab-paclitaxel
Drug: BMS-986504 · Drug: Pembrolizumab · Drug: Cisplatin · Drug: Carboplatin · Drug: Pemetrexed · Drug: Paclitaxel · Drug: Nab-paclitaxel
Drug: Pembrolizumab · Other: Placebo · Drug: Cisplatin · Drug: Carboplatin · Drug: Pemetrexed · Drug: Paclitaxel · Drug: Nab-paclitaxel
Drug: Pembrolizumab · Other: Placebo · Drug: Cisplatin · Drug: Carboplatin · Drug: Pemetrexed · Drug: Paclitaxel · Drug: Nab-paclitaxel
Drug: BMS-986504 · Drug: Pembrolizumab · Drug: Cisplatin · Drug: Carboplatin · Drug: Pemetrexed · Drug: Paclitaxel · Drug: Nab-paclitaxel
Drug: Pembrolizumab · Other: Placebo · Drug: Cisplatin · Drug: Carboplatin · Drug: Pemetrexed · Drug: Paclitaxel · Drug: Nab-paclitaxel
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Progression-free survival (PFS) by RECIST v1.1
Phase 2
Time frame: Up to 2 years
PFS by RECIST v1.1 per BICR
Phase 3
Time frame: Up to 5 years
Overall Survival (OS)
Phase 3
Time frame: Up to 5 years
Objective response (OR) (confirmed complete response (CR) or partial response (PR))
Phase 2
Time frame: Up to 2 years
Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD))
Phase 2
Time frame: Up to 2 years
Duration of response (DOR) (CR or PR)
Phase 2
Time frame: Up to 2 years
Time to objective response (TTOR) (CR or PR)
Phase 2
Time frame: Up to 2 years
Number of participants with treatment-related and all-cause adverse events (AEs)
Phase 2
Time frame: Up to 90 days from the last dose
Number of participants with serious adverse events (SAEs) including fatal AEs
Phase 2
Time frame: Up to 90 days from the last dose
Number of participants with adverse events leading to dose interruption, dose reduction, and study treatment discontinuation
Phase 2
Time frame: Up to 90 days from the last dose
Number of participants with laboratory abnormalities
Phase 2
Time frame: Up to 90 days from the last dose
OR (confirmed CR or PR)
Phase 3
Time frame: Up to 5 years
Disease control (BOR of confirmed CR, confirmed PR, or SD)
Phase 3
Time frame: Up to 5 years
DOR (CR or PR)
Phase 3
Time frame: Up to 5 years
PFS by RECIST v1.1 per Investigator
Phase 3
Time frame: Up to 5 years
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Showing the first 100 of 321 sites across 34 countries. Choose a country and city above to see the rest.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Jan 2026 (actual). Primary completion is estimated for Aug 2031, 67 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Navlimetostat