臨床研究等提出・公開システム

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

MK-3475A SC vs Pembrolizumab IV for PD-L1 TPS Strong Metastatic NSCLC

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Not Recruiting

Oct. 25, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

-Has histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC.
-Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided.
-Has a life expectancy of at least 3 months.

-Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
-Has received prior systemic anticancer therapy for their 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 that is >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 or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
-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 the past 2 years.
-Has an active infection requiring systemic therapy.
-Has a history of HIV infection.
-Has a history of Hepatitis B or known active Hepatitis C virus infection.
-Has a history of allogeneic tissue/solid organ transplant.
-Has not adequately recovered from major surgery or have ongoing surgical complications.

Both

First-line treatment of metastatic NSCLC with PD-L1 TPS>=50%

-Arm 1: MK-3475A SC q6w for up to 18 cycles
-Arm 2: Pembrolizumab IV q6w for up to 18 cycles

-Cycle 1 AUC0-6wks
-Steady-state (Cycle 3) Ctrough
The primary analysis will be performed on the model-based values of Ctrough

-Cycle 1: Cmax and Ctrough
-Steady state (Cycle 3): AUC0-6wks and Cmax
-Antipembrolizumab antibodies
-Cycle 1: Model-based Ctrough
-Steady state: Model-based Ctrough
-Objective response
-PFS
-OS
-DOR
-AE
-Discontinuation of study intervention due to AEs
-PRO

+81-48-722-1111

Oct. 16, 2024

Yes

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

USA/Germany/Poland/Romania/Spain/Turkiye/UK/Guatemala/Peru/South Korea/China