A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion

Last updated: May 12, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

BMS-986504

Clinical Study ID

NCT06855771
CA240-0009
2024-519814-29
U1111-1315-9473
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected intumor tissue and willingness to provide archival/fresh samples at screening forcentral MTAP status confirmation.

  • Advanced or metastatic NSCLC not amenable to curative therapies after progression onprior therapies at the time of enrollment (based on the American Joint Committee onCancer, Ninth Edition).

  • At least 1 measurable lesion as per RECIST v1.1.

  • Documented radiographic disease progression on or after the most recent line oftreatment.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

  • Participant must be ≥ 18 years of age (or the legal age of consent in thejurisdiction in which the study is taking place) at the time of signing the ICF.

  • Capability to swallow tablets intact (without chewing or crushing).

Exclusion

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 ofstudy 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

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: BMS-986504
Phase: 2
Study Start date:
May 30, 2025
Estimated Completion Date:
December 30, 2031

Connect with a study center

  • Local Institution - 0057

    Campbelltown, New South Wales 2560
    Australia

    Site Not Available

  • Local Institution - 0059

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Local Institution - 0058

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Local Institution - 0097

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Local Institution - 0039

    Beijing, Beijing 101149
    China

    Site Not Available

  • Local Institution - 0055

    Xiamen, Fujian 361003
    China

    Site Not Available

  • Local Institution - 0050

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Local Institution - 0043

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Local Institution - 0056

    Changchun, Jilin 130000
    China

    Site Not Available

  • Local Institution - 0054

    Jinan, Shandong 250117
    China

    Site Not Available

  • Local Institution - 0044

    Linyi, Shandong 276001
    China

    Site Not Available

  • Local Institution - 0049

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • Local Institution - 0053

    Linhai, Zhejiang 317000
    China

    Site Not Available

  • Local Institution - 0045

    Marseille, Bouches-du-Rhône 13385
    France

    Site Not Available

  • Local Institution - 0015

    La Tronche, Isère 38700
    France

    Site Not Available

  • Local Institution - 0012

    Saint-Herblain, Loire-Atlantique 44800
    France

    Site Not Available

  • Local Institution - 0095

    Vandoeuvre lès Nancy, Meurthe-et-Moselle 54511
    France

    Site Not Available

  • Local Institution - 0041

    Bron, Rhône 69677
    France

    Site Not Available

  • Local Institution - 0096

    Paris, Île-de-France 75014
    France

    Site Not Available

  • Local Institution - 0013

    Paris, 75014
    France

    Site Not Available

  • Local Institution - 0027

    Paris, 75970
    France

    Site Not Available

  • Local Institution - 0068

    München, Bayern 81377
    Germany

    Site Not Available

  • Local Institution - 0070

    Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Local Institution - 0066

    Halle, Sachsen-Anhalt 06120
    Germany

    Site Not Available

  • Local Institution - 0067

    Köln, 50937
    Germany

    Site Not Available

  • Local Institution - 0065

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Local Institution - 0020

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Local Institution - 0026

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Local Institution - 0025

    Monza, Lombardia 20900
    Italy

    Site Not Available

  • Local Institution - 0022

    Milan, Milano 20162
    Italy

    Site Not Available

  • Local Institution - 0024

    Bologna, 40138
    Italy

    Site Not Available

  • Local Institution - 0019

    Milan, 20133
    Italy

    Site Not Available

  • Local Institution - 0023

    Padova, 35128
    Italy

    Site Not Available

  • Local Institution - 0092

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • Local Institution - 0094

    Sendai, Miyagi 9810914
    Japan

    Site Not Available

  • Local Institution - 0093

    Hirakata, Osaka 573-1191
    Japan

    Site Not Available

  • Local Institution - 0060

    Wieliszew, Mazowieckie 05-135
    Poland

    Site Not Available

  • Local Institution - 0064

    Prabuty, Pomorskie 82-550
    Poland

    Site Not Available

  • Local Institution - 0029

    Bucharest, București 022338
    Romania

    Site Not Available

  • Local Institution - 0040

    Bucharest, București 020335
    Romania

    Site Not Available

  • Local Institution - 0036

    Florești, Cluj 407280
    Romania

    Site Not Available

  • Local Institution - 0031

    Craiova, Dolj 200542
    Romania

    Site Not Available

  • Local Institution - 0034

    Cluj, 400015
    Romania

    Site Not Available

  • Local Institution - 0030

    Iași, 700106
    Romania

    Site Not Available

  • Local Institution - 0032

    Iași, 700483
    Romania

    Site Not Available

  • Local Institution - 0074

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Local Institution - 0073

    Hospitalet, Barcelona [Barcelona] 08907
    Spain

    Site Not Available

  • Local Institution - 0071

    Madrid, Madrid, Comunidad De 28041
    Spain

    Site Not Available

  • Local Institution - 0076

    Madrid, Madrid, Comunidad De 28046
    Spain

    Site Not Available

  • Local Institution - 0077

    Madrid, Madrid, Comunidad De 28034
    Spain

    Site Not Available

  • Local Institution - 0075

    Málaga, 29011
    Spain

    Site Not Available

  • Local Institution - 0089

    Sevilla, 41013
    Spain

    Site Not Available

  • Local Institution - 0072

    València, 46026
    Spain

    Site Not Available

  • Local Institution - 0002

    Solna, Stockholms Län [se-01] 171 64
    Sweden

    Site Not Available

  • Local Institution - 0003

    Gothenburg, Västra Götalands Län [se-14] 413 45
    Sweden

    Site Not Available

  • Local Institution - 0069

    Birmingham, England B15 2TH
    United Kingdom

    Site Not Available

  • Local Institution - 0008

    London, London, City Of w1g 6ad
    United Kingdom

    Site Not Available

  • Local Institution - 0004

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Local Institution - 0088

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • Local Institution - 0099

    Boise, Idaho 83712
    United States

    Site Not Available

  • Local Institution - 0090

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Local Institution - 0100

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Local Institution - 0018

    New York, New York 10065
    United States

    Site Not Available

  • Local Institution - 0079

    Shirley, New York 11967
    United States

    Site Not Available

  • Local Institution - 0091

    Canton, Ohio 44718
    United States

    Site Not Available

  • Local Institution - 0098

    Portland, Oregon 97225
    United States

    Site Not Available

  • Local Institution - 0103

    Portland, Oregon 97239
    United States

    Site Not Available

  • Local Institution - 0102

    Houston, Texas 77030
    United States

    Site Not Available

  • Local Institution - 0078

    Seattle, Washington 98109
    United States

    Site Not Available

  • Local Institution - 0084

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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