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
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT07063745
This clinical trial evaluates the efficacy of BMS-986504 combined with pembrolizumab and chemotherapy in treating metastatic non-small cell lung cancer with homozygous MTAP deletion. Participants receive either BMS-986504 or a placebo alongside pembrolizumab and chemotherapy agents like cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel. Eligibility criteria focus on first-line treatment candidates.
Patient Parameters
| Parameter | Options |
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Program Overview
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
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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