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

JRCT ID: jRCT2031240445

Registered date:30/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: First-line treatment of metastatic NSCLC with PD-L1 TPS>=50%
• Date of first enrollment: 25/10/2024
• Target sample size: 20
• Countries of recruitment: USA,Japan,Germany,Japan,Poland,Japan,Romania,Japan,Spain,Japan,Turkiye,Japan,UK,Japan,Guatemala,Japan,Peru,Japan,South Korea,Japan,China,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

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

Secondary Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-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.

Exclude 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 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.

Related Information

• Primary Sponsor: Tanaka Yoshiyuki