EA5163/1709 Firstline Pembrolizumab Alone or in Combination with Pemetrexed and Carboplatin in Induction / Maintenance or Postprogression in Treating Patients with Stage IV Non-squamous Non-small Cell Lung Cancer - Mercy Medical Center

EA5163/1709 Firstline Pembrolizumab Alone or in Combination with Pemetrexed and Carboplatin in Induction / Maintenance or Postprogression in Treating Patients with Stage IV Non-squamous Non-small Cell Lung Cancer

Posted on: January 30, 2020

This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer. Eligibility includes being at least 18 years old and:

•Patients must have histologically or cytologically confirmed stage IV non-squamous non‐small cell lung cancer

•Patients must have PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells

•Patients must NOT have received the following: * Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC. Patients treated with any prior checkpoint inhibitors for metastatic lung cancer are ineligible. Chemotherapy for non-metastatic disease (e.g. adjuvant therapy) or immunotherapy for locally advanced stage III disease is allowed if at least 6 months have elapsed between the last dose of the prior therapy and study registration. Local therapy, e.g. palliative radiation, is allowed as long as a period of 14 days has passed between completion of local therapy and study registration

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