Status:
ACTIVE_NOT_RECRUITING
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Metastatic Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab (+) berahyaluronidase alfa vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of...
Detailed Description
Japan extension study will require approximately six years which includes one additional year (beyond the global study's last participant last study related contact) from the time the first participan...
Eligibility Criteria
Inclusion
- The key inclusion and exclusion criteria include but are not limited to the following:
- 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
- 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
Key Trial Info
Start Date :
June 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2028
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06212752
Start Date
June 13 2023
End Date
May 22 2028
Last Update
November 12 2025
Active Locations (18)
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1
Fujita Health University ( Site 4406)
Toyoake, Aichi-ken, Japan, 470-1192
2
Kurume University Hospital ( Site 4412)
Kurume, Fukuoka, Japan, 830-0011
3
Gunma Prefectural Cancer Center ( Site 4416)
Otashi, Gunma, Japan, 373-8550
4
National Hospital Organization Hokkaido Cancer Center ( Site 4415)
Sapporo, Hokkaido, Japan, 003-0804