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)

• Status: Not yet recruiting
• Trial end date: 2028-05-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme LLC
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel; Pembrolizumab; Pemetrexed

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.