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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)

ClinicalTrials.gov Identifier: NCT05722015 (view full study on clinicaltrials.gov)
Condition:  Metastatic Non-small Cell Lung Cancer
Status:  Active, not recruiting


Official Title: A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer

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.

Interventional
Phase 3
378
February 2023
May 2028
September 2024
18 years and older
All
No


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.

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