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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06855771




Registration number
NCT06855771
Ethics application status
Date submitted
27/02/2025
Date registered
4/03/2025

Titles & IDs
Public title
A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion
Scientific title
A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion After Progression on Prior Therapies
Secondary ID [1] 0 0
2024-519814-29
Secondary ID [2] 0 0
CA240-0009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986504

Experimental: Arm A: BMS-986504 Dose 1 -

Experimental: Arm B: BMS-986504 Dose 2 -


Treatment: Drugs: BMS-986504
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [1] 0 0
Up to 3 years after the last participant's last dose of study treatment
Secondary outcome [1] 0 0
Number of participants who achieve disease control (DC) as assessed by RECIST v1.1
Timepoint [1] 0 0
Up to 3 years after the last participant's last dose of study treatment
Secondary outcome [2] 0 0
Number of participants who achieve clinical benefit (CB) as assessed by RECIST v1.1
Timepoint [2] 0 0
Up to 3 years after the last participant's last dose of study treatment
Secondary outcome [3] 0 0
Duration of response (DOR) as assessed by RECIST v1.1
Timepoint [3] 0 0
Up to 3 years after the last participant's last dose of study treatment
Secondary outcome [4] 0 0
Progression-free survival (PFS) as assessed by RECIST v1.1
Timepoint [4] 0 0
Up to 3 years after the last participant's last dose of study treatment
Secondary outcome [5] 0 0
Time to objective response (TTOR) as assessed by RECIST v1.1
Timepoint [5] 0 0
Up to 3 years after the last participant's last dose of study treatment
Secondary outcome [6] 0 0
Number of participants with adverse events (AE)
Timepoint [6] 0 0
Up to 28 days after the last dose of study treatment
Secondary outcome [7] 0 0
Number of participants with Serious AEs (SAEs)
Timepoint [7] 0 0
Up to 28 days after the last dose of study treatment
Secondary outcome [8] 0 0
Number of participants with AEs leading to dose interruption, reduction, or discontinuation
Timepoint [8] 0 0
Up to 28 days after the last dose of study treatment
Secondary outcome [9] 0 0
Number of deaths
Timepoint [9] 0 0
Up to 28 days after the last dose of study treatment
Secondary outcome [10] 0 0
Number of participants who achieve Objective Response (OR) as assessed by RECIST v1.1
Timepoint [10] 0 0
Up to 3 years after the last participant's last dose of study treatment
Secondary outcome [11] 0 0
Overall Survival (OS)
Timepoint [11] 0 0
Up to 3 years after the last participant's last dose of study treatment
Secondary outcome [12] 0 0
Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score and symptom score
Timepoint [12] 0 0
Up to 28 days after the last dose of study treatment
Secondary outcome [13] 0 0
Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core Function Global Health Status functional scale score
Timepoint [13] 0 0
Up to 28 days after the last dose of study treatment
Secondary outcome [14] 0 0
Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the EORTC-QLQ-F17 quality-of-life (QoL) functional scale score
Timepoint [14] 0 0
Up to 28 days after the last dose of study treatment

Eligibility
Key inclusion criteria
* Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central MTAP status confirmation.
* Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition).
* At least 1 measurable lesion as per RECIST v1.1.
* Documented radiographic disease progression on or after the most recent line of treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Participant must be = 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.
* Capability to swallow tablets intact (without chewing or crushing).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active brain metastases or carcinomatous meningitis.
* History of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
* Prior treatment with a PRMT5 or MAT2A inhibitor.
* Known severe hypersensitivity to study treatment and/or any of its excipients.
* 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2031
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Local Institution - 0057 - Campbelltown
Recruitment hospital [2] 0 0
Local Institution - 0059 - Camperdown
Recruitment hospital [3] 0 0
Local Institution - 0058 - Woolloongabba
Recruitment hospital [4] 0 0
Local Institution - 0097 - Adelaide
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
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
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin
Country [7] 0 0
China
State/province [7] 0 0
Beijing
Country [8] 0 0
China
State/province [8] 0 0
Fujian
Country [9] 0 0
China
State/province [9] 0 0
Guangxi
Country [10] 0 0
China
State/province [10] 0 0
Jiangxi
Country [11] 0 0
China
State/province [11] 0 0
Jilin
Country [12] 0 0
China
State/province [12] 0 0
Shandong
Country [13] 0 0
China
State/province [13] 0 0
Zhejiang
Country [14] 0 0
France
State/province [14] 0 0
Bouches-du-Rhône
Country [15] 0 0
France
State/province [15] 0 0
Isère
Country [16] 0 0
France
State/province [16] 0 0
Loire-Atlantique
Country [17] 0 0
France
State/province [17] 0 0
Meurthe-et-Moselle
Country [18] 0 0
France
State/province [18] 0 0
Rhône
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
France
State/province [20] 0 0
Île-de-France
Country [21] 0 0
Germany
State/province [21] 0 0
Bayern
Country [22] 0 0
Germany
State/province [22] 0 0
Hessen
Country [23] 0 0
Germany
State/province [23] 0 0
Sachsen-Anhalt
Country [24] 0 0
Germany
State/province [24] 0 0
Köln
Country [25] 0 0
Germany
State/province [25] 0 0
Wuerzburg
Country [26] 0 0
Italy
State/province [26] 0 0
Campania
Country [27] 0 0
Italy
State/province [27] 0 0
Lombardia
Country [28] 0 0
Italy
State/province [28] 0 0
Milano
Country [29] 0 0
Italy
State/province [29] 0 0
Bologna
Country [30] 0 0
Italy
State/province [30] 0 0
Milan
Country [31] 0 0
Italy
State/province [31] 0 0
Padova
Country [32] 0 0
Japan
State/province [32] 0 0
Chiba
Country [33] 0 0
Japan
State/province [33] 0 0
Miyagi
Country [34] 0 0
Japan
State/province [34] 0 0
Osaka
Country [35] 0 0
Poland
State/province [35] 0 0
Mazowieckie
Country [36] 0 0
Poland
State/province [36] 0 0
Pomorskie
Country [37] 0 0
Romania
State/province [37] 0 0
Bucure?ti
Country [38] 0 0
Romania
State/province [38] 0 0
Cluj
Country [39] 0 0
Romania
State/province [39] 0 0
Dolj
Country [40] 0 0
Romania
State/province [40] 0 0
Ia?i
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona [Barcelona]
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid, Comunidad De
Country [43] 0 0
Spain
State/province [43] 0 0
Málaga
Country [44] 0 0
Spain
State/province [44] 0 0
Sevilla
Country [45] 0 0
Spain
State/province [45] 0 0
València
Country [46] 0 0
Sweden
State/province [46] 0 0
Stockholms Län [se-01]
Country [47] 0 0
Sweden
State/province [47] 0 0
Västra Götalands Län [se-14]
Country [48] 0 0
United Kingdom
State/province [48] 0 0
England
Country [49] 0 0
United Kingdom
State/province [49] 0 0
London, City Of
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Newcastle upon Tyne

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 Study Connect Contact Center www.BMSStudyConnect.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


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/NCT06855771