Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Death

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Amino Acids

Osimertinib

Pemetrexed

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Tyrosine

Four 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 will be the sequential treatment strategy at progression until resistance develops.

Four 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.

Pembrolizumab, pemetrexed, platinum

Osimertinib will be the sequential treatment strategy at progression until resistance develops.

Mengzhao Wang, MD

Yan Xu, MD

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.

Four 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 will be the sequential treatment strategy at progression.

A Prospective Study of Pembrolizumab Combining Chemotherapy in Advanced NSCLC Patients With EGFR Exon 21 Point Mutation.

A Phase II Study of Pembrolizumab Plus Platinum and Pemetrexed as First Line Therapy in Advanced Non-squamous Non-small Cell Lung Cancer Patients With EGFR Exon 21 Point Mutation and Programmed Cell Death Ligand 1 Expression

The result of the study and all the supporting information will be shared in the form of publishing article.

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.

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

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

Evaluate adverse events of any cause, treatment-related adverse events, immune-mediated adverse events according to NCI-CTCAE V5.0

Proportion of patients with Complete and Partial Responses to first-line therapy.

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.

Spots Global Cancer Trial Database for pembrolizumab, pemetrexed, platinum