Clinical trial NCT06855771: A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-03-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate 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.


Eligibility criteria: 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).

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.

Primary outcomes:
measure: Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Up to 3 years after the last participant's last dose of study treatment
Secondary outcomes:
measure: Number of participants who achieve disease control (DC) as assessed by RECIST v1.1
timeFrame: Up to 3 years after the last participant's last dose of study treatment
measure: Number of participants who achieve clinical benefit (CB) as assessed by RECIST v1.1
timeFrame: Up to 3 years after the last participant's last dose of study treatment
measure: Duration of response (DOR) as assessed by RECIST v1.1
timeFrame: Up to 3 years after the last participant's last dose of study treatment
measure: Progression-free survival (PFS) as assessed by RECIST v1.1
timeFrame: Up to 3 years after the last participant's last dose of study treatment
measure: Time to objective response (TTOR) as assessed by RECIST v1.1
timeFrame: Up to 3 years after the last participant's last dose of study treatment
measure: Number of participants with adverse events (AE)
timeFrame: Up to 28 days after the last dose of study treatment
measure: Number of participants with Serious AEs (SAEs)
timeFrame: Up to 28 days after the last dose of study treatment
measure: Number of participants with AEs leading to dose interruption, reduction, or discontinuation
timeFrame: Up to 28 days after the last dose of study treatment
measure: Number of deaths
timeFrame: Up to 28 days after the last dose of study treatment
measure: Number of participants who achieve Objective Response (OR) as assessed by RECIST v1.1
timeFrame: Up to 3 years after the last participant's last dose of study treatment
measure: Overall Survival (OS)
timeFrame: Up to 3 years after the last participant's last dose of study treatment
measure: 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
timeFrame: Up to 28 days after the last dose of study treatment
measure: 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
timeFrame: Up to 28 days after the last dose of study treatment
measure: 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
timeFrame: Up to 28 days after the last dose of study treatment
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Local Institution - 0088
state: Alaska
city: Boise
country: United States
facility: Local Institution - 0099
state: Idaho
city: Boston
country: United States
facility: Local Institution - 0090
state: Massachusetts
city: Detroit
country: United States
facility: Local Institution - 0100
state: Michigan
city: New York
country: United States
facility: Local Institution - 0018
state: New York
city: Shirley
country: United States
facility: Local Institution - 0079
state: New York
city: Canton
country: United States
facility: Local Institution - 0091
state: Ohio
city: Portland
country: United States
facility: Local Institution - 0098
state: Oregon
city: Portland
country: United States
facility: Local Institution - 0103
state: Oregon
city: Houston
country: United States
facility: Local Institution - 0102
state: Texas
city: Seattle
country: United States
facility: Local Institution - 0078
state: Washington
city: Milwaukee
country: United States
facility: Local Institution - 0084
state: Wisconsin
city: Campbelltown
country: Australia
facility: Local Institution - 0057
state: New South Wales
city: Camperdown
country: Australia
facility: Local Institution - 0059
state: New South Wales
city: Woolloongabba
country: Australia
facility: Local Institution - 0058
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution - 0097
state: South Australia
city: Beijing
country: China
facility: Local Institution - 0039
state: Beijing
city: Xiamen
country: China
facility: Local Institution - 0055
state: Fujian
city: Nanning
country: China
facility: Local Institution - 0050
state: Guangxi
city: Nanchang
country: China
facility: Local Institution - 0043
state: Jiangxi
city: Changchun
country: China
facility: Local Institution - 0056
state: Jilin
city: Jinan
country: China
facility: Local Institution - 0054
state: Shandong
city: Linyi
country: China
facility: Local Institution - 0044
state: Shandong
city: Hangzhou
country: China
facility: Local Institution - 0049
state: Zhejiang
city: Linhai
country: China
facility: Local Institution - 0053
state: Zhejiang
city: Marseille
country: France
facility: Local Institution - 0045
state: Bouches-du-Rhône
city: La Tronche
country: France
facility: Local Institution - 0015
state: Isère
city: Saint-Herblain
country: France
facility: Local Institution - 0012
state: Loire-Atlantique
city: Vandoeuvre lès Nancy
country: France
facility: Local Institution - 0095
state: Meurthe-et-Moselle
city: Bron
country: France
facility: Local Institution - 0041
state: Rhône
city: Paris
country: France
facility: Local Institution - 0013
city: Paris
country: France
facility: Local Institution - 0027
city: Paris
country: France
facility: Local Institution - 0096
state: Île-de-France
city: München
country: Germany
facility: Local Institution - 0068
state: Bayern
city: Frankfurt
country: Germany
facility: Local Institution - 0070
state: Hessen
city: Halle
country: Germany
facility: Local Institution - 0066
state: Sachsen-Anhalt
city: Köln
country: Germany
facility: Local Institution - 0067
city: Wuerzburg
country: Germany
facility: Local Institution - 0065
city: Napoli
country: Italy
facility: Local Institution - 0020
state: Campania
city: Napoli
country: Italy
facility: Local Institution - 0026
state: Campania
city: Monza
country: Italy
facility: Local Institution - 0025
state: Lombardia
city: Milan
country: Italy
facility: Local Institution - 0022
state: Milano
city: Bologna
country: Italy
facility: Local Institution - 0024
city: Milan
country: Italy
facility: Local Institution - 0019
city: Padova
country: Italy
facility: Local Institution - 0023
city: Kashiwa
country: Japan
facility: Local Institution - 0092
state: Chiba
city: Sendai
country: Japan
facility: Local Institution - 0094
state: Miyagi
city: Hirakata
country: Japan
facility: Local Institution - 0093
state: Osaka
city: Wieliszew
country: Poland
facility: Local Institution - 0060
state: Mazowieckie
city: Prabuty
country: Poland
facility: Local Institution - 0064
state: Pomorskie
city: Bucharest
country: Romania
facility: Local Institution - 0040
state: București
city: Bucharest
country: Romania
facility: Local Institution - 0029
state: București
city: Florești
country: Romania
facility: Local Institution - 0036
state: Cluj
city: Craiova
country: Romania
facility: Local Institution - 0031
state: Dolj
city: Cluj
country: Romania
facility: Local Institution - 0034
city: Iași
country: Romania
facility: Local Institution - 0030
city: Iași
country: Romania
facility: Local Institution - 0032
city: Barcelona
country: Spain
facility: Local Institution - 0074
state: Barcelona [Barcelona]
city: Hospitalet
country: Spain
facility: Local Institution - 0073
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Local Institution - 0077
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Local Institution - 0071
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Local Institution - 0076
state: Madrid, Comunidad De
city: Málaga
country: Spain
facility: Local Institution - 0075
city: Sevilla
country: Spain
facility: Local Institution - 0089
city: València
country: Spain
facility: Local Institution - 0072
city: Solna
country: Sweden
facility: Local Institution - 0002
state: Stockholms Län [se-01]
city: Gothenburg
country: Sweden
facility: Local Institution - 0003
state: Västra Götalands Län [se-14]
city: Birmingham
country: United Kingdom
facility: Local Institution - 0069
state: England
city: London
country: United Kingdom
facility: Local Institution - 0008
state: London, City Of
city: Newcastle upon Tyne
country: United Kingdom
facility: Local Institution - 0004
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: