BMS-986504 for Non-Small Cell Lung Cancer

Recruiting at 69 trial locations

Overseen By First line of the email MUST contain NCT # and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Must not be taking: PRMT5, MAT2A inhibitors

Disqualifiers: Active brain metastases, gastrointestinal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 years

130 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults over 18 with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) that can't be cured and has worsened after previous treatments. Participants must have a certain type of genetic change in their cancer cells called homozygous MTAP deletion, at least one measurable tumor, and be able to perform daily activities with minimal assistance.

Inclusion Criteria

I am fully active or have some restrictions but can still care for myself.

At least 1 measurable lesion as per RECIST v1.1

My lung cancer is confirmed and lacks MTAP, and I can provide tissue samples.

Exclusion Criteria

I have active brain tumors or cancer in the lining of my brain.

I don't have stomach issues that would affect medication absorption.

Known severe hypersensitivity to study treatment and/or any of its excipients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986504 monotherapy for advanced or metastatic NSCLC with homozygous MTAP deletion

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Treatment Details

Interventions

• BMS-986504

Trial Overview The study tests BMS-986504 as a solo treatment for NSCLC patients who have the specific MTAP deletion. It aims to see how safe it is and how well it works after other treatments have failed. Patients will take this medication orally, meaning they'll swallow tablets whole.

Participant Groups

Group I: Arm B: BMS-986504 Dose 2 Experimental Treatment 1 Intervention

Group II: Arm A: BMS-986504 Dose 1 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania