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

Description

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.

Conditions

Lung Cancer, Non-Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Peoria

Illinois Cancer Care ( Site 0101), Peoria, Illinois, United States, 61615

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp and Dohme LLC

Study Record Dates

2030-02-11