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
Single group
Pembrolizumab, pemetrexed, platinum
DrugFour cycles of platinum and pemetrexed in combination with pembrolizumab will be administered as first line therapy and up to 31 cycles pemetrexed and pembrolizumab maintenance therapy every 3 weeks.
Osimertinib
DrugOsimertinib will be the sequential treatment strategy at progression until resistance develops.
progression free survival 1 (PFS1)
the time length from enrollment to any of the following events: disease progression with first line therapy or death from any cause. Disease progression will be assessed according to RECIST 1.1
progression free survival 2 (PFS2)
the time length from enrollment to any of the following events: disease progression with Osimertinib or death from any cause. Disease progression will be assessed according to RECIST 1.1
Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Evaluate adverse events of any cause, treatment-related adverse events, immune-mediated adverse events according to NCI-CTCAE V5.0
objective response rate (ORR)
Proportion of patients with Complete and Partial Responses to first-line therapy.
Life quality score
Evaluate life quality score according to Karnofsky performance status (KPS). On a scale of 10, higher scores indicate better health. A score of 0 is defined as death, on a 100-point scale, indicating normal physical fitness with no obvious symptoms and signs.
Exploratory biomarker analysis
Blood samples will be collected from patients on three occasions: before treatment, at the time of disease progression on first-line therapy, and at the time of disease progression on second-line therapy. 15ml blood samples will be collected each time for PBMC assay. Tumor samples will be collected: 10 formalin-fixed, paraffin-embedded sections. Tumor samples will be subjected to genetic testing. Blood samples will be analyzed by flow cytometry.
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