Lung Cancer Clinical Trial
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)
This study is to assess the pharmacokinetics (PK) and safety of SC MK-3475A vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are MK-3475A subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.
The key inclusion and exclusion criteria include but are not limited to the following:
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.
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.
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There are 4 Locations for this study
Clermont Florida, 34711, United States More Info
Orange City Florida, 32763, United States More Info
Hattiesburg Mississippi, 39401, United States More Info
Changhua County Changhua, 50006, Taiwan More Info
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