Study

Overview

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, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50% or Greater

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.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

160

Study Start Date:

November 2024

Estimated Study Completion Date:

February 2030

Estimated Primary Completion Date:

June 2026

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

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.

Locations

No Contacts or Locations in US/Canada Provided

Results

No Study Results Posted

Study Detail

A clinical study of Pembrolizumab (+) Berahyaluronidase alfa (MK-3475A) to treat newly-diagnosed metastatic non-small cell lung cancer (MK-3475A-F84)

Overview

Eligibility

CRITERIA

Locations

Results