Study Comparing BMS-986504 with Pembrolizumab and Chemotherapy Versus Placebo in First-line Treatment for Metastatic Non-small Cell Lung Cancer with MTAP Deletion
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT07063745
This clinical trial is testing whether adding a new drug, BMS-986504, to the standard treatment of pembrolizumab and chemotherapy can provide better outcomes for patients with metastatic non-small cell lung cancer who have a specific genetic deletion called MTAP.
Patient Parameters
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Program Overview
The goal of this study is to find out if combining a new drug, BMS-986504, with pembrolizumab and chemotherapy is more effective than using a placebo with pembrolizumab and chemotherapy for treating patients with metastatic non-small cell lung cancer (NSCLC) who have a genetic deletion known as MTAP. This study aims to determine if the new combination can offer better clinical benefits for these patients.
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alaska Oncology and Hematology | 99508 | Anchorage | Alaska |
| Local Institution - 0388 | 85054 | Phoenix | Arizona |
| Local Institution - 0120 | 85724 | Tucson | Arizona |
| Highlands Oncology Group | 72762 | Springdale | Arkansas |
| Local Institution - 0407 | 90033 | Los Angeles | California |
| Local Institution - 0444 | 90067 | Los Angeles | California |
| Local Institution - 0152 | 33316 | Fort Lauderdale | Florida |
| Local Institution - 0389 | 32224 | Jacksonville | Florida |
| Local Institution - 0430 | 33709 | St. Petersburg | Florida |
| St. Luke's Cancer Institute: Boise | 83712 | Boise | Idaho |
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