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Active Not Recruiting
NCT06212752
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)-Japan Extension
Conditions: Metastatic Non-small Cell Lung Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 39
Sponsor: Merck Sharp & Dohme LLC
Location: Fujita Health University ( Site 4406) Toyoake Aichi-ken
Summary
This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab (+) berahyaluronidase alfa vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult Japanese participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab (+) berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.
Eligibility Criteria
The key inclusion and exclusion criteria include but are not limited to the following:
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
Source: ClinicalTrials.gov (NCT06212752). StuddyBuddy aggregates publicly available trial information.