A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT05722015
This clinical trial evaluates the pharmacokinetics and safety of SC pembrolizumab with berahyaluronidase alfa versus IV pembrolizumab in adults with metastatic NSCLC. Eligible participants must have confirmed NSCLC and a life expectancy of at least 3 months. Interventions include SC and IV pembrolizumab, chemotherapy agents like pemetrexed, cisplatin, carboplatin, paclitaxel, nab-paclitaxel, and supportive drugs like filgrastim.
Patient Parameters
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Program Overview
This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.
Eligibility Criteria
Inclusion Criteria
- Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC)
- Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
- Has a life expectancy of at least 3 months
Exclusion Criteria
- Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Has received prior systemic anticancer therapy for metastatic NSCLC
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
- Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids
- Has received radiation therapy to the lung (>30 Gray) within 6 months of start of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has an active infection requiring systemic therapy
- Has a history of human immunodeficiency virus (HIV) infection
- Has a history of Hepatitis B or C
- Has not adequately recovered from major surgery or has ongoing surgical complications
- Has a history of allogenic tissue/solid organ transplant
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023) | 85004 | Phoenix | Arizona |
| Clermont Oncology Center ( Site 0018) | 34711 | Clermont | Florida |
| Mid Florida Hematology and Oncology Center ( Site 0010) | 32763 | Orange City | Florida |
| University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022) | 60612 | Chicago | Illinois |
| Orchard Healthcare Research Inc. ( Site 0011) | 60077 | Skokie | Illinois |
| Franciscan Health Lafayette East ( Site 0020) | 47905 | Lafayette | Indiana |
| Mercy Health-Paducah Cancer Center ( Site 0006) | 42003 | Paducah | Kentucky |
| Hattiesburg Clinic Hematology/Oncology ( Site 0008) | 39401 | Hattiesburg | Mississippi |
| Central Care Cancer Center - Bolivar ( Site 0017) | 65613 | Bolivar | Missouri |
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