A phase II, single-arm, open-label study evaluating efficacy, safety and feasibility of combined chemotherapy and pembrolizumab as first line therapy and Osimertinib as second line therapy in advanced non squamous NSCLC adult patients with epidermal growth factor receptor (EGFR) exon 21 point mutation and programmed cell death receptor ligand 1 (PD-L1) positive.
Male or female, ≥18 years old
Primary non-squamous non-small cell lung cancer(NSCLC) with stage IV (AJCC stage,8th Edition) confirmed by cytology or histology
Patients who have not used any anti-tumor therapy drugs such as targeted drugs, chemotherapy or immunotherapy and patients after surgery are acceptable
EGFR exon 21 point mutation confirmed by gene test of tissue or blood and PD-L1 (22C3) TPS≥1% confirmed by immunohistochemical method
patients who have active autoimmune disease which needs systemic treatment like disease relievers, corticosteroids, or immunosuppressants) in the last 2 years e. Alternative therapies ( such as thyroxine, insulin, and physiologic corticosteroid replacement therapy of adrenal or pituitary function insufficiency) are permitted)
History of pneumonia (non-infectious)/interstitial lung disease which require s steroid treatment or a current pneumonia/interstitial lung disease
Previously diagnosed immunodeficiency diseases, such as immunoglobulin deficiency, aplastic anemia
Known history of human immunodeficiency virus (HIV) infection
Peking Union Medical College Hospital
Lead sponsor