A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06698042

Patient View

This clinical study evaluates the pharmacokinetics of pembrolizumab administered subcutaneously with berahyaluronidase alfa versus intravenously in patients with newly-diagnosed metastatic NSCLC. Eligible participants must have a confirmed diagnosis of squamous or nonsquamous NSCLC and measurable disease. The study involves administering pembrolizumab (+) berahyaluronidase alfa SC and pembrolizumab IV on Day 1 of each cycle.

Patient Parameters

Program Overview

Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body.

Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to compare what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.

Eligibility Criteria

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
  • Measurable disease as assessed by the local site investigator/radiology.

Exclusion Criteria

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
  • Received prior systemic anticancer therapy for their metastatic NSCLC.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Active infection requiring systemic therapy.

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