ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

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

Quick Facts

Study Start:2024-11-21
Study Completion:2030-02-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06698042

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
  2. * Measurable disease as assessed by the local site investigator/radiology.
  1. * Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
  2. * Received prior systemic anticancer therapy for their metastatic NSCLC.
  3. * Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  4. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  5. * Active autoimmune disease that has required systemic treatment in the past 2 years.
  6. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  7. * Active infection requiring systemic therapy.

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp and Dohme LLC

Study Locations (Sites)

Providence Medical Foundation ( Site 0117)
Fullerton, California, 92835
United States
Illinois Cancer Care ( Site 0101)
Peoria, Illinois, 61615
United States
Montefiore Medical Center ( Site 0104)
The Bronx, New York, 10461
United States
University of Cincinnati Medical Center ( Site 0112)
Cincinnati, Ohio, 45219
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp and Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-21
Study Completion Date2030-02-11

Study Record Updates

Study Start Date2024-11-21
Study Completion Date2030-02-11

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Cancer
  • Non-Small Cell Lung Cancer