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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3

Conditions: Lung Cancer; Non-Small Cell Lung Cancer

Treatments: Biological: Pembrolizumab; Biological: Pembrolizumab (+) Berahyaluronidase alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT06698042

jRCT2031240445 (Registry Identifier)

U1111-1306-1214 (Other Identifier)

2024-513165-39 (Registry Identifier)

3475A-F84

MK-3475A-F84 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Pembrolizumab (+) Berahyaluronidase alfa

Experimental group

Description:

Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.

Treatment:

Biological: Pembrolizumab (+) Berahyaluronidase alfa

Pembrolizumab

Active Comparator group

Description:

"Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course,

Treatment:

Biological: Pembrolizumab