A Randomized Phase 2/3 Study of BMS-986504 in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

Study to Compare BMS-986504 with Pembrolizumab and Chemotherapy vs. Placebo

NCT: NCT07063745 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Bristol-Myers Squibb · Started: 2026-01-02 · Est. Completion: 2031-08-12

Plain English Summary

A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion is a Phase 3 clinical trial sponsored by Bristol-Myers Squibb studying Metastatic Non-small Cell Lung Cancer With MTAP Deletion. Tests a new drug (BMS-986504) in combination with existing treatments for lung cancer. For patients with advanced lung cancer and a specific genetic change (MTAP deletion). Participation involves taking study drugs and regular check-ups. Alternative treatments include standard chemotherapy and immunotherapy. The trial aims to enroll 590 participants.

Official Summary

The purpose of this study is to compare the clinical benefit of the combination of BMS-986504 (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible if you have advanced lung cancer and a specific genetic change. Not eligible if you have brain metastases or other specific conditions. Age: 18+ years. Health: Good overall health, no prior chemotherapy for lung cancer. This trial is studying Metastatic Non-small Cell Lung Cancer With MTAP Deletion, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

Measures how long patients live without the cancer getting worse and overall survival. The specific primary outcome measures are: Progression-free survival (PFS) by RECIST v1.1 (Up to 2 years); PFS by RECIST v1.1 per BICR (Up to 5 years); Overall Survival (OS) (Up to 5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a specific genetic subtype of lung cancer, filling a treatment gap for patients with MTAP deletion. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Metastatic Non-small Cell Lung Cancer With MTAP Deletion, where improved treatment options are needed.

Investor Insight

Market size is large, with strong competition but potential for significant approval and market share. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 590 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you have the specific genetic change (MTAP deletion). Participation involves taking study drugs and regular check-ups. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

  • Study Type: INTERVENTIONAL
  • Allocation: RANDOMIZED
  • Model: PARALLEL
  • Masking: QUADRUPLE
  • Enrollment: 590 participants

Interventions

  • DRUG: BMS-986504 — Specified dose on specified days
  • DRUG: Pembrolizumab — Specified dose on specified days
  • OTHER: Placebo — Specified dose on specified days
  • DRUG: Cisplatin — Specified dose on specified days
  • DRUG: Carboplatin — Specified dose on specified days

Primary Outcomes

  • Progression-free survival (PFS) by RECIST v1.1 (Up to 2 years)
  • PFS by RECIST v1.1 per BICR (Up to 5 years)
  • Overall Survival (OS) (Up to 5 years)

Secondary Outcomes

  • Objective response (OR) (confirmed complete response (CR) or partial response (PR)) (Up to 2 years)
  • Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD)) (Up to 2 years)
  • Duration of response (DOR) (CR or PR) (Up to 2 years)
  • Time to objective response (TTOR) (CR or PR) (Up to 2 years)
  • Number of participants with treatment-related and all-cause adverse events (AEs) (Up to 90 days from the last dose)

Full Eligibility Criteria

Inclusion Criteria

* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.
* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Participants must have at least 1 measurable lesion as per RECIST v1.1.

Exclusion Criteria

* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.
* Participants must not have symptomatic brain metastases or spinal cord compression.
* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).

Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.

* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Trial Locations

  • Alaska Oncology and Hematology, Anchorage, Alaska, United States
  • Mayo Clinic in Arizona - Phoenix, Phoenix, Arizona, United States
  • Local Institution - 0120, Tucson, Arizona, United States
  • Highlands Oncology Group, Springdale, Arkansas, United States
  • USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
  • Local Institution - 0444, Los Angeles, California, United States
  • Local Institution - 0152, Fort Lauderdale, Florida, United States
  • Mayo Clinic in Florida, Jacksonville, Florida, United States
  • Local Institution - 0430, St. Petersburg, Florida, United States
  • St. Luke's Cancer Institute: Boise, Boise, Idaho, United States
  • ...and 10 more locations

Frequently Asked Questions

What is clinical trial NCT07063745?

NCT07063745 is a Phase 3 INTERVENTIONAL study titled "A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion." It is currently recruiting and is sponsored by Bristol-Myers Squibb. The trial targets enrollment of 590 participants.

What conditions does NCT07063745 study?

This trial investigates treatments for Metastatic Non-small Cell Lung Cancer With MTAP Deletion. The primary condition under study is Metastatic Non-small Cell Lung Cancer With MTAP Deletion.

What treatments are being tested in NCT07063745?

The interventions being studied include: BMS-986504 (DRUG), Pembrolizumab (DRUG), Placebo (OTHER), Cisplatin (DRUG), Carboplatin (DRUG). Specified dose on specified days

What does Phase 3 mean for NCT07063745?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT07063745?

This trial is currently "Recruiting." It started on 2026-01-02. The estimated completion date is 2031-08-12.

Who is sponsoring NCT07063745?

NCT07063745 is sponsored by Bristol-Myers Squibb. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07063745?

The trial aims to enroll 590 participants. The trial is currently recruiting and accepting new participants.

How is NCT07063745 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT07063745?

The primary outcome measures are: Progression-free survival (PFS) by RECIST v1.1 (Up to 2 years); PFS by RECIST v1.1 per BICR (Up to 5 years); Overall Survival (OS) (Up to 5 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07063745 being conducted?

This trial is being conducted at 20 sites, including Anchorage, Alaska; Phoenix, Arizona; Tucson, Arizona; Springdale, Arkansas and 16 more sites (United States).

Where can I find official information about NCT07063745?

The official record for NCT07063745 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07063745. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07063745 testing in simple terms?

Tests a new drug (BMS-986504) in combination with existing treatments for lung cancer. For patients with advanced lung cancer and a specific genetic change (MTAP deletion).

Why is this trial significant?

This trial addresses a specific genetic subtype of lung cancer, filling a treatment gap for patients with MTAP deletion. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT07063745?

Possible side effects include nausea, fatigue, and changes in blood counts. Monitor closely for any new symptoms. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07063745?

Ask your doctor if you have the specific genetic change (MTAP deletion). Participation involves taking study drugs and regular check-ups. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07063745 signal from an investment perspective?

Market size is large, with strong competition but potential for significant approval and market share. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participation involves taking study drugs and regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More Metastatic Non-small Cell Lung Cancer With MTAP Deletion Trials

View all Metastatic Non-small Cell Lung Cancer With MTAP Deletion clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.