Clinical Study of Subcutaneous Pembrolizumab Coformulated with Hyaluronidase (MK-3475A) versus Intravenous Pembrolizumab, Given with Chemotherapy, in the First-line Treatment of Participants with Metastatic Non-Small Cell Lung Cancer
- Conditions
- First-line treatment of participants with metastatic nonsmall cell lung cancerMedDRA version: 21.1Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-501506-36-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 393
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 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, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method