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

Launched by MERCK SHARP & DOHME LLC · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat patients with metastatic non-small cell lung cancer (NSCLC), which is a type of lung cancer that has spread to other parts of the body. The researchers want to compare how a medication called pembrolizumab, which is usually given through an IV (intravenous) infusion, works when it is administered as a subcutaneous (under the skin) injection instead. This study is important because it could help find a more convenient way for patients to receive treatment.

To participate in this trial, individuals must have a confirmed diagnosis of NSCLC and measurable disease as determined by their doctor. However, people with certain conditions, such as small cell lung cancer or those who have received prior cancer treatments for their metastatic NSCLC, may not be eligible. If you choose to participate, you can expect to receive either the IV or subcutaneous form of the medication and be monitored closely by the research team. Overall, this trial aims to improve treatment options for patients with metastatic lung cancer.

Gender

ALL

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.