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

NCT06698042 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-04-01

No results posted yet for this study

Summary

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 learn what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.

Conditions

Interventions

BIOLOGICAL

Pembrolizumab (+) Berahyaluronidase alfa

Administered subcutaneously on Day 1 of each cycle

BIOLOGICAL

Pembrolizumab

Administered intravenously on Day 1 of each cycle

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp and Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2026-03-12
Completion
2030-02-11
FDA Drug
Yes

Countries

  • United States
  • China
  • Germany
  • Guatemala
  • Japan
  • Peru
  • Poland
  • Romania
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06698042 on ClinicalTrials.gov