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Clinical Trials List

Protocol NumberMK-3475A-D77
NCT Number(ClinicalTrials.gov Identfier)NCT05722015
Active

2023-01-01 - 2029-05-19

Phase III

Recruiting7

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

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, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Jen Yang Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic Non-small Cell Lung Cancer

Objectives

main purpose: (1) Compare the 1st cycle AUC of MK-3475A subcutaneous administration (SC) and pembrolizumab intravenous administration (IV) (2) Compare the steady state (3rd cycle) C trough of MK-3475A SC and pembrolizumab IV

Test Drug

MK-3475APembrolizumab (MK-3475)

Active Ingredient

Pembrolizumab and MK-5180 (recombinant human hyaluronidase)
Pembrolizumab (Humanized anti-PD-1 mAb)

Dosage Form

Injection
Injection

Dosage

165 mg/mL pembrolizumab and 2000 U/mL MK-5180/Vial
100 mg/4 mL/vial

Endpoints

Main evaluation indicators:
(1) First cycle AUC 0-6wks
(2) Steady state (3rd cycle) C trough

Inclution Criteria

Inclusion Criteria:

Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC).
Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated.
Has a life expectancy of at least 3 months.

Exclusion Criteria

Exclusion Criteria:

Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
Has received prior systemic anticancer therapy for metastatic NSCLC.
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids.
Has received radiation therapy to the lung (>30 Gray) within 6 months of start of study intervention.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has an active infection requiring systemic therapy.
Has a history of human immunodeficiency virus (HIV) infection.
Has a history of Hepatitis B or C.
Has not adequately recovered from major surgery or has ongoing surgical complications.
Has a history of allogenic tissue/solid organ transplant.

The Estimated Number of Participants

  • Taiwan

    28 participants

  • Global

    378 participants

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