Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon

Menu

Clinical Trial FAQs About Us
Search BMS Clinical Trials
BMS Recruiting Study icon

Recruiting

Trial ID CA240-0009  |   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)

Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 40
    Locations
  • BMS Recruiting Study icon
    Recruiting

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.

print Print
email Email

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • 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.
    1. 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).
      1. At least 1 measurable lesion as per RECIST v1.1.
        1. Documented radiographic disease progression on or after the most recent line of treatment.
          1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
            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.
              1. Capability to swallow tablets intact (without chewing or crushing).

                Exclusion Criteria

                Exclusion Criteria Icon
                • Active brain metastases or carcinomatous meningitis.
                  1. 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.
                    1. Prior treatment with a PRMT5 or MAT2A inhibitor.
                      1. Known severe hypersensitivity to study treatment and/or any of its excipients.
                        1. Other protocol-defined inclusion/exclusion criteria apply.
                          Additional Information *

                          Treatment Options

                          Study Arms

                          ASSIGNED INTERVENTION

                          Study Arms

                          Experimental: Arm A: BMS-986504 Dose 1

                          ASSIGNED INTERVENTION
                          • Drug: BMS-986504

                          Study Arms

                          Experimental: Arm B: BMS-986504 Dose 2

                          ASSIGNED INTERVENTION
                          • Drug: BMS-986504
                          Take the first step to see if you Match to a Clinical Trial – Check Your Eligibility
                          Check Your Eligibility
                          Answer some questions about Your health to see if you may match to this trial
                          Match to a Trial
                          If you are a match, click on the study to see the list of study site locations
                          Select a Study Site Location
                          Select a study site location that is convenient for you
                          Register
                          Provide your contact details for the study site to connect with you.

                          Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you