MK-3475A SC vs pembrolizumab IV, administered with chemotherapy, in treatment-naive metastatic NSCLC

JRCT ID: jRCT2031230049

Registered date:22/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Metastatic Non-small Cell Lung Cancer
• Date of first enrollment: 13/06/2023
• Target sample size: 39
• Countries of recruitment: USA,Japan,France,Japan,Hungary,Japan,Poland,Japan,Romania,Japan,South Africa,Japan,Spain,Japan,Turkey,Japan,Algeria,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,Guatemala,Japan,Taiwan,Japan,Thailand,Japan,China,Japan
• Study type: Interventional

Intervention(s)

- Arm 1: MK-3475A SC Q6W for up to 18 cycles in combination with platinum doublet chemotherapy.
- Arm 2: Pembrolizumab IV Q6W for up to 18 cycles in combination with platinum doublet chemotherapy.
- Platinum doublet chemotherapy.
-- Nonsquamous NSCLC: Up to 4 infusions of pemetrexed Q3W with investigator's
choice of a platinum chemotherapy (cisplatin Q3W or carboplatin Q3W), followed by
pemetrexed maintenance until one of the conditions for discontinuation of study intervention is met.
-- Squamous NSCLC: Up to 4 infusions of carboplatin Q3W with investigator's choice of a taxane (paclitaxel Q3W or nab-paclitaxel [Days 1, 8, 15, 22, 29, and 36 of Cycles 1 and 2]).

Outcome(s)

Primary Outcome

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

Secondary Outcome

- For descriptive comparison to pembrolizumab IV Q6W:
- Cycle 1: Cmax, Ctrough
- Cycle 3: AUC0-6 wks, Cmax
--For descriptive comparison to pembrolizumab IV Q3W:
- Model-based Ctrough at Cycle 1 and steady state
--ADA
--ORR
--PFS
--OS
--DOR
--Safety and tolerability
--PROs

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 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.

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 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.

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT05722015