The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT07063745
Ethics application status
Date submitted
3/07/2025
Date registered
14/07/2025
Date last updated
11/09/2025

Titles & IDs
Public title
A Study to Compare the Combination of 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 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
Secondary ID [1] 0 0
2025-521511-40
Secondary ID [2] 0 0
CA240-0029
Universal Trial Number (UTN)
Trial acronym
MountainTAP-29
Linked study record

Health condition
Health condition(s) or problem(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 intervention(s) / 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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 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
Time to objective response (TTOR) (CR or PR)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Duration of response (DOR) (CR or PR)
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
OR (confirmed CR or PR)
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Disease control (BOR of confirmed CR, confirmed PR, or SD)
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
DOR (CR or PR)
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
PFS
Timepoint [8] 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
Can healthy volunteers participate?
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Local Institution - 0382 - Birtinya
Recruitment hospital [3] 0 0
Local Institution - 0381 - Elizabeth Vale
Recruitment hospital [4] 0 0
Local Institution - 0431 - Hobart
Recruitment hospital [5] 0 0
Local Institution - 0367 - Ballarat Central
Recruitment hospital [6] 0 0
Local Institution - 0373 - Woolloongabba
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [6] 0 0
QLD 4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maine
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Austria
State/province [20] 0 0
Vienna
Country [21] 0 0
Belgium
State/province [21] 0 0
Antwerpen
Country [22] 0 0
Belgium
State/province [22] 0 0
Limburg
Country [23] 0 0
Belgium
State/province [23] 0 0
Namur
Country [24] 0 0
Belgium
State/province [24] 0 0
West-Vlaanderen
Country [25] 0 0
Belgium
State/province [25] 0 0
Brussels
Country [26] 0 0
Belgium
State/province [26] 0 0
Liège
Country [27] 0 0
Brazil
State/province [27] 0 0
Espírito Santo
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio Grande do Norte
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio Grande do Sul
Country [30] 0 0
Brazil
State/province [30] 0 0
Santa Catarina
Country [31] 0 0
Brazil
State/province [31] 0 0
São Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio de Janeiro
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Pazardzhik
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Haskovo
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Rousse
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Stara Zagora
Country [37] 0 0
China
State/province [37] 0 0
Anhui
Country [38] 0 0
China
State/province [38] 0 0
Beijing Municipality
Country [39] 0 0
China
State/province [39] 0 0
Fujian
Country [40] 0 0
China
State/province [40] 0 0
Guangdong
Country [41] 0 0
China
State/province [41] 0 0
Guangxi
Country [42] 0 0
China
State/province [42] 0 0
Hebei
Country [43] 0 0
China
State/province [43] 0 0
Heilongjiang
Country [44] 0 0
China
State/province [44] 0 0
Henan
Country [45] 0 0
China
State/province [45] 0 0
Hubei
Country [46] 0 0
China
State/province [46] 0 0
Hunan
Country [47] 0 0
China
State/province [47] 0 0
Jiangsu
Country [48] 0 0
China
State/province [48] 0 0
Jiangxi
Country [49] 0 0
China
State/province [49] 0 0
Liaoning
Country [50] 0 0
China
State/province [50] 0 0
Shaanxi
Country [51] 0 0
China
State/province [51] 0 0
Shandong
Country [52] 0 0
China
State/province [52] 0 0
Shanghai Municipality
Country [53] 0 0
China
State/province [53] 0 0
Shanxi
Country [54] 0 0
China
State/province [54] 0 0
Sichuan
Country [55] 0 0
China
State/province [55] 0 0
Zhejiang
Country [56] 0 0
China
State/province [56] 0 0
Nanjing
Country [57] 0 0
China
State/province [57] 0 0
Zhengzhou
Country [58] 0 0
Colombia
State/province [58] 0 0
Cundinamarca
Country [59] 0 0
Colombia
State/province [59] 0 0
Departamento de Córdoba
Country [60] 0 0
Czechia
State/province [60] 0 0
Hradec Králové
Country [61] 0 0
Czechia
State/province [61] 0 0
Olomouc
Country [62] 0 0
Denmark
State/province [62] 0 0
Capital Region
Country [63] 0 0
France
State/province [63] 0 0
Aquitaine
Country [64] 0 0
France
State/province [64] 0 0
Calvados
Country [65] 0 0
France
State/province [65] 0 0
Côte-d'Or
Country [66] 0 0
France
State/province [66] 0 0
Doubs
Country [67] 0 0
France
State/province [67] 0 0
Finistère
Country [68] 0 0
France
State/province [68] 0 0
Haute-Garonne
Country [69] 0 0
France
State/province [69] 0 0
Hérault
Country [70] 0 0
France
State/province [70] 0 0
Ille-et-Vilaine
Country [71] 0 0
France
State/province [71] 0 0
Loire-Atlantique
Country [72] 0 0
France
State/province [72] 0 0
Meurthe-et-Moselle
Country [73] 0 0
France
State/province [73] 0 0
Provence-Alpes-Côte d'Azur Region
Country [74] 0 0
France
State/province [74] 0 0
Puy-de-Dôme
Country [75] 0 0
France
State/province [75] 0 0
Rhône
Country [76] 0 0
France
State/province [76] 0 0
Val-de-Marne
Country [77] 0 0
France
State/province [77] 0 0
Paris
Country [78] 0 0
France
State/province [78] 0 0
Tours
Country [79] 0 0
Germany
State/province [79] 0 0
Bavaria
Country [80] 0 0
Greece
State/province [80] 0 0
Acha?a
Country [81] 0 0
Greece
State/province [81] 0 0
Attikí
Country [82] 0 0
Greece
State/province [82] 0 0
Kentrikí Makedonía
Country [83] 0 0
Greece
State/province [83] 0 0
Thessalía
Country [84] 0 0
Hong Kong
State/province [84] 0 0
Hksar
Country [85] 0 0
Hong Kong
State/province [85] 0 0
Shatin
Country [86] 0 0
Hungary
State/province [86] 0 0
Bekes County
Country [87] 0 0
Hungary
State/province [87] 0 0
Heves County
Country [88] 0 0
Hungary
State/province [88] 0 0
Veszprém megye
Country [89] 0 0
Hungary
State/province [89] 0 0
Budapest
Country [90] 0 0
India
State/province [90] 0 0
Karnataka
Country [91] 0 0
India
State/province [91] 0 0
Maharashtra
Country [92] 0 0
India
State/province [92] 0 0
National Capital Territory of Delhi
Country [93] 0 0
India
State/province [93] 0 0
Telangana
Country [94] 0 0
India
State/province [94] 0 0
Uttar Pradesh
Country [95] 0 0
Israel
State/province [95] 0 0
Central District
Country [96] 0 0
Israel
State/province [96] 0 0
Jerusalem
Country [97] 0 0
Israel
State/province [97] 0 0
Northern District
Country [98] 0 0
Italy
State/province [98] 0 0
Campania
Country [99] 0 0
Italy
State/province [99] 0 0
Friuli Venezia Giulia
Country [100] 0 0
Italy
State/province [100] 0 0
Torino
Country [101] 0 0
Italy
State/province [101] 0 0
Umbria
Country [102] 0 0
Italy
State/province [102] 0 0
Bologna
Country [103] 0 0
Italy
State/province [103] 0 0
Milan
Country [104] 0 0
Italy
State/province [104] 0 0
Ravenna
Country [105] 0 0
Japan
State/province [105] 0 0
Aichi-ken
Country [106] 0 0
Japan
State/province [106] 0 0
Chiba
Country [107] 0 0
Japan
State/province [107] 0 0
Gunma
Country [108] 0 0
Japan
State/province [108] 0 0
Hokkaido
Country [109] 0 0
Japan
State/province [109] 0 0
Hyogo
Country [110] 0 0
Japan
State/province [110] 0 0
Iwate
Country [111] 0 0
Japan
State/province [111] 0 0
Kanagawa
Country [112] 0 0
Japan
State/province [112] 0 0
Kochi
Country [113] 0 0
Japan
State/province [113] 0 0
Mie-ken
Country [114] 0 0
Japan
State/province [114] 0 0
Miyagi
Country [115] 0 0
Japan
State/province [115] 0 0
Osaka
Country [116] 0 0
Japan
State/province [116] 0 0
Saitama
Country [117] 0 0
Japan
State/province [117] 0 0
Tochigi
Country [118] 0 0
Japan
State/province [118] 0 0
Tokyo
Country [119] 0 0
Japan
State/province [119] 0 0
Yamaguchi
Country [120] 0 0
Japan
State/province [120] 0 0
Fukuoka
Country [121] 0 0
Japan
State/province [121] 0 0
Okayama
Country [122] 0 0
Malaysia
State/province [122] 0 0
Kuala Lumpur
Country [123] 0 0
Malaysia
State/province [123] 0 0
Sarawak
Country [124] 0 0
Mexico
State/province [124] 0 0
Jalisco
Country [125] 0 0
Mexico
State/province [125] 0 0
Mexico City
Country [126] 0 0
Mexico
State/province [126] 0 0
Nuevo León
Country [127] 0 0
Mexico
State/province [127] 0 0
Oaxaca
Country [128] 0 0
Mexico
State/province [128] 0 0
Chihuahua City
Country [129] 0 0
Netherlands
State/province [129] 0 0
Arnhem
Country [130] 0 0
Netherlands
State/province [130] 0 0
Groningen
Country [131] 0 0
Poland
State/province [131] 0 0
Greater Poland Voivodeship
Country [132] 0 0
Poland
State/province [132] 0 0
Lesser Poland Voivodeship
Country [133] 0 0
Poland
State/province [133] 0 0
Masovian Voivodeship
Country [134] 0 0
Poland
State/province [134] 0 0
Pomeranian Voivodeship
Country [135] 0 0
Poland
State/province [135] 0 0
Bydgoszcz
Country [136] 0 0
Romania
State/province [136] 0 0
Bucure?ti
Country [137] 0 0
Romania
State/province [137] 0 0
Cluj
Country [138] 0 0
Romania
State/province [138] 0 0
Dolj
Country [139] 0 0
Romania
State/province [139] 0 0
Ilfov
Country [140] 0 0
Romania
State/province [140] 0 0
Prahova
Country [141] 0 0
Romania
State/province [141] 0 0
Bucharest
Country [142] 0 0
Romania
State/province [142] 0 0
Cluj-Napoca
Country [143] 0 0
Romania
State/province [143] 0 0
Ia?i
Country [144] 0 0
South Korea
State/province [144] 0 0
Chungcheongbuk-do [Chungbuk]
Country [145] 0 0
South Korea
State/province [145] 0 0
Kyonggi-do
Country [146] 0 0
South Korea
State/province [146] 0 0
Seoul-teukbyeolsi [Seoul]
Country [147] 0 0
Spain
State/province [147] 0 0
Barcelona [Barcelona]
Country [148] 0 0
Spain
State/province [148] 0 0
Catalunya [Cataluña]
Country [149] 0 0
Spain
State/province [149] 0 0
Madrid, Comunidad de
Country [150] 0 0
Spain
State/province [150] 0 0
Málaga
Country [151] 0 0
Spain
State/province [151] 0 0
Seville
Country [152] 0 0
Spain
State/province [152] 0 0
Valencia
Country [153] 0 0
Taiwan
State/province [153] 0 0
Tainan
Country [154] 0 0
Taiwan
State/province [154] 0 0
Tainan City
Country [155] 0 0
Taiwan
State/province [155] 0 0
Taipei
Country [156] 0 0
Taiwan
State/province [156] 0 0
Taoyuan District
Country [157] 0 0
Thailand
State/province [157] 0 0
Bangkok
Country [158] 0 0
Turkey (Türkiye)
State/province [158] 0 0
Izmir
Country [159] 0 0
Turkey (Türkiye)
State/province [159] 0 0
Adana
Country [160] 0 0
Turkey (Türkiye)
State/province [160] 0 0
Ankara
Country [161] 0 0
Turkey (Türkiye)
State/province [161] 0 0
Antalya
Country [162] 0 0
Turkey (Türkiye)
State/province [162] 0 0
Bursa
Country [163] 0 0
Turkey (Türkiye)
State/province [163] 0 0
Edirne
Country [164] 0 0
United Kingdom
State/province [164] 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
8559073286
Fax 0 0
Email 0 0
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/disclosure-commitment.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/disclosure-commitment.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.