Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Met… (NCT03976323) | Clinical Trial Compass
CompletedPhase 3
Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)
United States1,003 participantsStarted 2019-06-28
Plain-language summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus (vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
✓. Have stage IV nonsquamous NSCLC.
✓. Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
✓. Have measurable disease based on RECIST 1.1.
✓. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
✓. Have a life expectancy of at least 3 months.
✓. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.
✓. Have not received prior systemic treatment for their advanced/metastatic NSCLC.
Exclusion criteria
✕. Has predominantly squamous cell histology NSCLC.
✕. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
✕. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
✕. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
✕. Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.
✕. Has an active autoimmune disease that has required systemic treatment in past 2 years.
✕. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
✕. Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.