BMS-986504 for Non-Small Cell Lung Cancer

Recruiting at 118 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BMS-986504 for individuals with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). The goal is to determine the safety and effectiveness of this treatment, particularly for those with a specific genetic change whose cancer has not responded to other treatments. Participants will receive one of two different doses to identify the most effective option. Suitable candidates have NSCLC with a specific genetic deletion and have experienced cancer progression after previous treatments. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that BMS-986504 is likely to be safe for humans?

Research shows that BMS-986504 has been well tolerated in earlier studies with patients who have various types of advanced cancer. These studies indicate that the treatment has effectively fought cancer cells. Although side effects are common with cancer treatments, the research so far suggests that patients generally managed BMS-986504 safely. This provides confidence in its safety for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for non-small cell lung cancer?

BMS-986504 is unique because it introduces a novel approach to treating non-small cell lung cancer by potentially targeting specific pathways that current treatments, like chemotherapy and immunotherapy, do not address. Unlike traditional chemotherapy, which attacks rapidly dividing cells and can affect healthy cells too, BMS-986504 may offer a more targeted action, reducing side effects. Researchers are excited about its potential to enhance effectiveness and improve patient outcomes by focusing on a new mechanism of action that could work synergistically with or as an alternative to existing therapies.

What evidence suggests that BMS-986504 might be an effective treatment for Non-Small Cell Lung Cancer?

Research has shown that BMS-986504 may help treat advanced or spreading Non-Small Cell Lung Cancer (NSCLC) with MTAP deletion. This trial will evaluate two different doses of BMS-986504. The drug blocks a protein complex called PRMT5-MTA, which cancer cells need to survive. By stopping this complex, the drug can cause cancer cells to die. Early results suggest that BMS-986504 is well-tolerated by patients and shows strong activity against various tumors. These findings offer hope for those whose cancer has worsened after other treatments. ^{1 2 3 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. iaslc.org iaslc.org/iaslc-news/press-release/bms-986504-demonstrates-durable-responses-mtap-deleted-nsclc-including

BMS-986504 Demonstrates Durable Responses in MTAP- ... BMS-986504 is designed to selectively target and inhibit PRMT5 when it's bound to MTA (PRMT5-MTA complex), leading to cell death in MTAP-deleted ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06855771

NCT06855771 | A Study of BMS-986504 in Participants ... 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 ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3011

BMS-986504 in patients (pts) with advanced solid tumors ... BMS-986504 was found to be well tolerated and demonstrated antitumor activity in multiple tumors. Here, we report clinical results and the first PK and PD ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/579958

A Study of BMS-986504 in Participants With Pre-treated ... 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 ...

5. news.bms.com news.bms.com/news/details/2025/Bristol-Myers-Squibb-to-Present-Data-at-ASCO-2025-Highlighting-Differentiated-Research-Platform-of-Oncology-Treatments-and-Innovative-Research-Pipeline/default.aspx

Bristol Myers Squibb to Present Data at ASCO® 2025 ... Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data across its oncology portfolio and pipeline at the 2025 American Society of Clinical ...

6. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT06855771

Trial ID CA240-0009 | NCT06855771 - BMS Clinical Trials 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

7. sciencedirect.com sciencedirect.com/science/article/pii/S1556086425021367

P3.18.71 CA240-0007: BMS-986504 With Anti-PD-1 or ... BMS-986504 will be evaluated with anti-PD-1 treatment in MTAP-del non-small cell lung cancer and other solid tumors, and with chemo in pancreatic ductal ...