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)

Официальное название

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

Обзор

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.

Вмешательства

• Препарат BMS-986504
  Specified dose on specified days

Первичные конечные точки

• Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Срок оценки: Up to 3 years after the last participant's last dose of study treatment]

Вторичные конечные точки (12)

• Number of participants who achieve disease control (DC) as assessed by RECIST v1.1 [Срок оценки: 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 [Срок оценки: Up to 3 years after the last participant's last dose of study treatment]
• Duration of response (DOR) as assessed by RECIST v1.1 [Срок оценки: Up to 3 years after the last participant's last dose of study treatment]
• Progression-free survival (PFS) as assessed by RECIST v1.1 [Срок оценки: 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 [Срок оценки: Up to 3 years after the last participant's last dose of study treatment]
• Number of participants with adverse events (AE) [Срок оценки: Up to 28 days after the last dose of study treatment]
• Number of participants with Serious AEs (SAEs) [Срок оценки: Up to 28 days after the last dose of study treatment]
• Number of participants with AEs leading to dose interruption, reduction, or discontinuation [Срок оценки: Up to 28 days after the last dose of study treatment]
• Number of deaths [Срок оценки: 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 [Срок оценки: Up to 3 years after the last participant's last dose of study treatment]
• Overall Survival (OS) [Срок оценки: 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 [Срок оценки: Up to 28 days after the last dose of study treatment]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 12 центров

• 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
• … и ещё 4 центра

Франция · 9 центров

• 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
• … и ещё 1 центр

Китай · 8 центров

• Beijing Chest Hospital,Capital Medical University — Пекин
• 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 — Цзинань
• LinYi Cancer Hospital — Linyi
• Sir Run Run Shaw Hospital of Zhejiang University School of Medicine — Ханчжоу
• Taizhou Hospital of Zhejiang Province — Linhai

Испания · 8 центров

• 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

Италия · 7 центров

• 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

Румыния · 7 центров

• 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

Германия · 5 центров

• 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

Австралия · 4 центра

• GenesisCare - Campbelltown — Campbelltown
• Chris O'Brien Lifehouse — Camperdown
• Princess Alexandra Hospital — Woolloongabba
• Local Institution - 0097 — Adelaide

Япония · 3 центра

• National Cancer Center Hospital East — Kashiwa
• Sendai Kousei Hospital — Sendai
• Kansai Medical University Hospital — Hirakata

Великобритания · 3 центра

• Queen Elizabeth Hospital Birmingham — Birmingham
• Sarah Cannon Research Institute UK — London
• Freeman Hospital — Newcastle upon Tyne

Польша · 2 центра

• Mazowiecki Szpital Onkologiczny — Wieliszew
• Szpital Specjalistyczny w Prabutach Spolka z o.o. — Prabuty

Швеция · 2 центра

• Karolinska Universitetssjukhuset Solna — Solna
• Sahlgrenska Universitetssjukhuset — Gothenburg

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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