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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07063745




Registration number
Help: Registration number
NCT07063745
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
3/07/2025
Date registered
Help: Date registered
14/07/2025
Date last updated
Help: Date last updated
23/10/2026

Titles & IDs
Public 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
Scientific 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
Additional trial identifiers [1] 0 0
2025-521511-40
Additional trial identifiers [2] 0 0
CA240-0029
Universal Trial Number (UTN)
Trial acronym
MountainTAP-29
Related trial records

Health condition
Health condition(s) studied:
Metastatic Non-small Cell Lung Cancer With MTAP Deletion 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - BMS-986504
Treatment: Drugs - Pembrolizumab
Other interventions - Placebo
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab-paclitaxel

Active comparator: Arm A: BMS-986504 + Pembrolizumab + Chemotherapy -

Active comparator: Arm B: BMS-986504 + Pembrolizumab + Chemotherapy -

Placebo comparator: Arm C: Placebo + Pembrolizumab + Chemotherapy -

Placebo comparator: Arm D: Placebo + Pembrolizumab + Chemotherapy -

Active comparator: Arm E: BMS-986504 + Pembrolizumab + Chemotherapy -

Placebo comparator: Arm F: Placebo + Pembrolizumab + Chemotherapy -


Treatment: Drugs: BMS-986504
Specified dose on specified days

Treatment: Drugs: Pembrolizumab
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days

Treatment: Drugs: Cisplatin
Specified dose on specified days

Treatment: Drugs: Carboplatin
Specified dose on specified days

Treatment: Drugs: Pemetrexed
Specified dose on specified days

Treatment: Drugs: Paclitaxel
Specified dose on specified days

Treatment: Drugs: Nab-paclitaxel
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) by RECIST v1.1
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
PFS by RECIST v1.1 per BICR
Timepoint [2] 0 0
Up to 5 years
Primary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Objective response (OR) (confirmed complete response (CR) or partial response (PR))
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD))
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Duration of response (DOR) (CR or PR)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Time to objective response (TTOR) (CR or PR)
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Number of participants with treatment-related and all-cause adverse events (AEs)
Timepoint [5] 0 0
Up to 90 days from the last dose
Secondary outcome [6] 0 0
Number of participants with serious adverse events (SAEs) including fatal AEs
Timepoint [6] 0 0
Up to 90 days from the last dose
Secondary outcome [7] 0 0
Number of participants with adverse events leading to dose interruption, dose reduction, and study treatment discontinuation
Timepoint [7] 0 0
Up to 90 days from the last dose
Secondary outcome [8] 0 0
Number of participants with laboratory abnormalities
Timepoint [8] 0 0
Up to 90 days from the last dose
Secondary outcome [9] 0 0
OR (confirmed CR or PR)
Timepoint [9] 0 0
Up to 5 years
Secondary outcome [10] 0 0
Disease control (BOR of confirmed CR, confirmed PR, or SD)
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
DOR (CR or PR)
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
PFS by RECIST v1.1 per Investigator
Timepoint [12] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/01/2026
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/08/2031
Actual
Sample size
Target
590
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Local Institution - 0432 - Liverpool
Recruitment hospital [2] 0 0
GenesisCare St Leonards - St Leonards
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
Grampians Health - Ballarat Central
Recruitment hospital [8] 0 0
Local Institution - 0368 - Garran
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [8] 0 0
ACT 2605 - Garran
Recruitment outside Australia
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Rhône
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Germany
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Baden-Wurttemberg
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Germany
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Bavaria
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Berlin
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Attikí
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PC
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Thessalía
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Greece
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Thessaloniki
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Hksar
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Shatin
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Bekes County
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Hungary
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Heves County
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Hungary
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Veszprém megye
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Budapest
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India
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Karnataka
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India
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Maharashtra
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India
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India
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India
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Israel
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Israel
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Campania
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Bologna
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Milan
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Rome
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Turin
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Verona
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Japan
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Aichi-ken
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Japan
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Chiba
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Japan
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Gunma
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Hokkaido
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Hyogo
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Iwate
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Kanagawa
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Kochi
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Miyagi
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Fukuoka
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Ilfov
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Spain
State/province [198] 0 0
Madrid
Country [199] 0 0
Spain
State/province [199] 0 0
Málaga
Country [200] 0 0
Spain
State/province [200] 0 0
Seville
Country [201] 0 0
Spain
State/province [201] 0 0
Valencia
Country [202] 0 0
Sweden
State/province [202] 0 0
Västra Götalands Län [se-14]
Country [203] 0 0
Taiwan
State/province [203] 0 0
Tainan
Country [204] 0 0
Taiwan
State/province [204] 0 0
Taipei
Country [205] 0 0
Taiwan
State/province [205] 0 0
Taoyuan
Country [206] 0 0
Thailand
State/province [206] 0 0
Bangkok
Country [207] 0 0
Turkey (Türkiye)
State/province [207] 0 0
Izmir
Country [208] 0 0
Turkey (Türkiye)
State/province [208] 0 0
Adana
Country [209] 0 0
Turkey (Türkiye)
State/province [209] 0 0
Ankara
Country [210] 0 0
Turkey (Türkiye)
State/province [210] 0 0
Antalya
Country [211] 0 0
Turkey (Türkiye)
State/province [211] 0 0
Bursa
Country [212] 0 0
Turkey (Türkiye)
State/province [212] 0 0
Edirne
Country [213] 0 0
Turkey (Türkiye)
State/province [213] 0 0
Istanbul
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Leicestershire
Country [215] 0 0
United Kingdom
State/province [215] 0 0
London, City of

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07063745