Clinical Study of Combination Therapy With Ectiecinib, Pemetrexed and Platinum in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutations.

Inclusion Criteria

• •1. Age 18-75;
• •2. Expected survival is at least 12 weeks;
• •3. Metastatic non-squamous non-small cell lung cancer with EGFR mutations confirmed by histological or cytological examination;
• •4. Received two cycles of pemetrexed/platinum chemotherapy with no progress (efficacy was evaluated as SD or PR);
• •5. Tumor specimens must be provided before patients receive ectinib combined chemotherapy to complete the EGFR gene test. There is no need to clarify the EGFR mutation status before the initial pemetrexed/platinum chemotherapy;
• •6. Volunteers who participate in exploratory studies need provide tumor samples for the laboratory to complete the study on anti-tumor drug sensitivity of microfluidic chip technology;
• •7. Volunteers who participate in exploratory studies need provide blood samples to complete the analysis of blood biomarkers and disease progression/anti-tumor efficacy, tolerance and safety of drugs;
• •8. 0-1 ECOG score;
• •9. Patients may have a history of brain parenchymal metastasis, and local treatment (surgery and/or radiotherapy) is required for good control of symptoms, and hormone maintenance therapy is not required;
• •10. According to RECIST criteria 1.1, there is at least one measurable lesion that has not been irradiated:1) if there is at least one measurable lesion, and if there is only one lesion, the nature of new organisms at the lesion site must be confirmed by cytology or histology;2) for patients with at least one lesion diameter that can be accurately measured by any of the following methods, computed tomography (CT) or magnetic resonance (MRI) of chest or abdomen, the diameter of which should be at least 20mm by conventional methods or at least 10mm by spiral CT;
• •11. The level of organ function must meet the following requirements:1) bone marrow: median granulocyte absolute count (ANC) ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥9 g/dL;2) liver: serum bilirubin ≤1.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal value (ALT ≤ 5 times the upper limit of normal value if there is liver metastasis);3) upper limit of serum creatinine \<1.5 times normal value;Creatinine clearance ≥50 mL/min (calculated by cockroft-gault10 formula) for patients with low body weight or patients with significantly different values calculated by the two formulas, it is recommended to measure creatinine clearance by other methods, such as EDTA method, inulin clearance method, or 24-hour urinalysis.4) international standardized ratio of prothrombin time (INR) ≤1.5 and partial thrombin time (APTT) ≤1.5 upper limit of normal value in patients who have not received anticoagulation therapy.Patients receiving full or parenteral anticoagulant therapy can enter the clinical trial as long as the dose of anticoagulant is stable for at least 2 weeks before entering the clinical study and the results of coagulation test are within the limits of local treatment.
• •12. Women of reproductive age must have negative serum pregnancy test results within 7 days prior to treatment;All enrolled patients (male or female) should take adequate barrier contraception during and within 4 weeks after treatment;
• •13. Patients must be able to understand and sign informed consent voluntarily, prior to any trial procedures.