MK-3475A SC vs pembrolizumab IV, administered with chemotherapy, in treatment-naive metastatic NSCLC
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2031230049
- Lead Sponsor
- Koh Yasuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 39
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.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Cycle 1 AUC0-6 wks <br>-Steady-state (Cycle 3) Ctrough (the primary analysis will be performed on the model-based values of Ctrough)
- Secondary Outcome Measures
Name Time Method - For descriptive comparison to pembrolizumab IV Q6W:<br>- Cycle 1: Cmax, Ctrough<br>- Cycle 3: AUC0-6 wks, Cmax <br> --For descriptive comparison to pembrolizumab IV Q3W:<br>- Model-based Ctrough at Cycle 1 and steady state<br> --ADA<br> --ORR<br> --PFS<br> --OS<br> --DOR<br> --Safety and tolerability <br> --PROs