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Recruiting NCT06855771

A Study of Navlimetostat (BMS-986504) in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)

Phase II Interventional Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986504.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, China, France, Germany +7
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of Navlimetostat (BMS-986504) Monotherapy in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion After Progression on Prior Therapies

Overview

The purpose of this study is to evaluate the safety and efficacy of Navlimetostat (BMS-986504) monotherapy in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion after progression on prior therapies.

Interventions

  • Drug BMS-986504
    Specified dose on specified days

Primary outcome measures

  • Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Time frame: Up to 3 years after the last participant's last dose of study treatment]
Secondary outcome measures (12)
  • Number of participants who achieve disease control (DC) as assessed by RECIST v1.1 [Time frame: Up to 3 years after the last participant's last dose of study treatment]
  • Number of participants who achieve clinical benefit (CB) as assessed by RECIST v1.1 [Time frame: Up to 3 years after the last participant's last dose of study treatment]
  • Duration of response (DOR) as assessed by RECIST v1.1 [Time frame: Up to 3 years after the last participant's last dose of study treatment]
  • Progression-free survival (PFS) as assessed by RECIST v1.1 [Time frame: Up to 3 years after the last participant's last dose of study treatment]
  • Time to objective response (TTOR) as assessed by RECIST v1.1 [Time frame: Up to 3 years after the last participant's last dose of study treatment]
  • Number of participants with adverse events (AE) [Time frame: Up to 28 days after the last dose of study treatment]
  • Number of participants with Serious AEs (SAEs) [Time frame: Up to 28 days after the last dose of study treatment]
  • Number of participants with AEs leading to dose interruption, reduction, or discontinuation [Time frame: Up to 28 days after the last dose of study treatment]
  • Number of deaths [Time frame: Up to 28 days after the last dose of study treatment]
  • Number of participants who achieve Objective Response (OR) as assessed by RECIST v1.1 [Time frame: Up to 3 years after the last participant's last dose of study treatment]
  • Overall Survival (OS) [Time frame: Up to 3 years after the last participant's last dose of study treatment]
  • 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 [Time frame: Up to 28 days after the last dose of study treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Alaska Oncology and Hematology — Anchorage
  • Local Institution - 0099 — Boise
  • Dana-Farber Cancer Institute — Boston
  • Karmanos Cancer Institute — Detroit
  • Washington University School of Medicine — St Louis
  • Memorial Sloan Kettering Cancer Center — New York
  • Local Institution - 0079 — Shirley
  • Gabrail Cancer Center — Canton
  • … and 4 more centers
France · 9 centers
  • Local Institution - 0045 — Marseille
  • Chu Grenoble Alpes — La Tronche
  • Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes — Saint-Herblain
  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois — Vandœuvre-lès-Nancy
  • Hospices Civils de Lyon - Hopital Louis Pradel — Bron
  • Hopitaux Universitaires Paris Centre-Hopital Cochin — Paris
  • Institut Curie — Paris
  • Hôpital Tenon — Paris
  • … and 1 more center
China · 8 centers
  • Beijing Chest Hospital,Capital Medical University — Beijing
  • The First Affiliated hospital of Xiamen University — Xiamen
  • Guangxi Medical University Affiliated Tumor Hospital — Nanning
  • The First Affiliated Hospital of Nanchang University — Nanchang
  • Shandong Cancer Hospital — Jinan
  • LinYi Cancer Hospital — Linyi
  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine — Hangzhou
  • Taizhou Hospital of Zhejiang Province — Linhai
Spain · 8 centers
  • Hospital Universitari Vall d'Hebron — Barcelona
  • Institut Català d'Oncologia - L'Hospitalet — Hospitalet
  • Hospital Universitario Ramón y Cajal — Madrid
  • Hospital Universitario 12 de Octubre — Madrid
  • Hospital Universitario La Paz — Madrid
  • H.R.U Málaga - Hospital General — Málaga
  • Hospital Universitario Virgen Del Rocio — Seville
  • Hospital Universitari i Politecnic La Fe — Valencia
Italy · 7 centers
  • AOU della Campania Luigi Vanvitelli — Naples
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale — Naples
  • Fondazione IRCCS San Gerardo dei Tintori — Monza
  • ASST Grande Ospedale Metropolitano Niguarda — Milan
  • Istituto Oncologico Veneto IRCCS — Padova
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola — Bologna
  • Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
Romania · 7 centers
  • Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu" — Bucharest
  • SC Radiotherapy Center Cluj SRL — Florești
  • Centrul de Oncologie "Sfântul Nectarie" — Craiova
  • Centrul de Diagnostic si Tratament Provita — Bucharest
  • Institutul Oncologic Cluj — Cluj-Napoca
  • S.C. Centrul de Oncologie Euroclinic S.R.L. — Iași
  • Institutul Regional de Oncologie — Iași
Germany · 5 centers
  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen — München
  • Universitätsklinikum Frankfurt Goethe-Universität — Frankfurt am Main
  • Krankenhaus Martha-Maria Halle-Dölau — Halle
  • Universitaetsklinikum Koeln — Cologne
  • Universitaetsklinikum Wuerzburg — Würzburg
Australia · 4 centers
  • GenesisCare - Campbelltown — Campbelltown
  • Chris O'Brien Lifehouse — Camperdown
  • Princess Alexandra Hospital — Woolloongabba
  • Local Institution - 0097 — Adelaide
Japan · 3 centers
  • National Cancer Center Hospital East — Kashiwa
  • Sendai Kousei Hospital — Sendai
  • Kansai Medical University Hospital — Hirakata
United Kingdom · 3 centers
  • Queen Elizabeth Hospital Birmingham — Birmingham
  • Sarah Cannon Research Institute UK — London
  • Freeman Hospital — Newcastle upon Tyne
Poland · 2 centers
  • Mazowiecki Szpital Onkologiczny — Wieliszew
  • Szpital Specjalistyczny w Prabutach Spolka z o.o. — Prabuty
Sweden · 2 centers
  • Karolinska Universitetssjukhuset Solna — Solna
  • Sahlgrenska Universitetssjukhuset — Gothenburg

Identifiers

NCT: NCT06855771 · CA240-0009 · 2024-519814-29 · U1111-1315-9473

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗