Efficacy of Targeted Therapy Combined Chemotherapy in Advanced EGFR Positive NSCLC Patients

Inclusion Criteria

• •1. Volunteer for clinical research, fully understand, inform and sign informed consent forms (Informed Consent Form, ICF), willing to follow and be able to complete all trial procedures.
• •2. 18 to 80 years old (with critical values) when signing ICF.
• •3. Histopathology or hemology diagnostics of phase IIIB or IV (AJCC Version 8) NSCLC that cannot be surgicalor-able or radiotherapy.
• •4. Patients have never received systemic treatment throughout the body for phase IIIB or IV NSCLC(Neoadjuvant or adjuvant chemotherapy is excluded).
• •5. Known EGFR sensitivity mutations with concurrent other Driver gene mutations, such as T790M，TP53，RB1，PTEN，CDKN，PIK3A，DDR, KRAS and so on.
• •6. The end of non-systematic anti-tumor therapy is not only 2 weeks from the end of the study drug, and the treatment-related AE is restored to CTCAE 4.03 to level 1 (except for level 2 hair loss).
• •7. Within 4 weeks prior to randomization, at least one measurable target lesions assessed by irRC in accordance with RECIST 1.1 requirements.
• •8. The ECOG PS score for 7 days prior to the first drug use of the study drug was 0 or 1.
• •9. The expected lifetime is more than 12 weeks.
• •10. The main organ function sits well, i.e. meets the following criteria (no blood transfusion, albumin, recombinant human platelet production or Colony-stimulating factor (CSF) treatment within 14 days prior to the first drug use in this study):
• •(1). Absolute neutrophil count \>15.0 x 10\^9/L; (2). Platelet count ≥ 100 x 10\^9/L; (3). Hemoglobins ≥ 90 g/L; (4). Total bilirubin ≤.5 x ULN (except Gilbert syndrome, total bilirubin ≤ 3.0 mg/dL); (5). AST (SGOT) ≤ 2.5 x ULN, for patients with liver metastasis, ≤5.0 x ULN; (6). ALT (SGPT) is 2.5 x ULN, for patients with liver metastasis, ≤5.0 x ULN; (7). Clotting function: activated part of the clotting enzyme time (APTT) ≤ 1.5 x ULN, clotting enzyme raw time (PT) or international standardized ratio (INR) ≤1.5 x ULN; (8). Creatinine ≤1.5xULN, or creatinine clearance ≥60 mL/min (Cockcroft-Gault method).
• •11\. Female patients must meet one of the following:
• •1. . Menopause (defined as having no menstruation for at least 1 year and no other reason for confirmation other than menopause);
• •2. . Sterilization performed (removal of the ovaries and/or uterus);
• •3. . Fertility, but must meet: Serum pregnancy tests must be negative within 7 days of randomization and agree to use 1% annual failure rate of contraception or to maintain abstinence (avoiding heterosexual intercourse) (at least 120 days after the signing of an informed consent form to the last time the drug was administered) (1% annual failure rate of contraceptive methods including bilateral tubal ligation, male sterilization, correct use of ovulation-suppressing hormones, release of intrauterine and intrauterine devices) and intrauterine devices.
• •12\. Male patients must meet the requirement to consent to abstinence (avoiding heterosexual intercourse) or to take contraception, provided that when the partner is a woman of childbearing age or who is pregnant, male patients must maintain abstinence or use condom contraception to prevent exposure to the embryo during treatment and for at least 150 days after the end of administration of the drug. Regular abstinence (e.g. calendar days, ovulation periods, basic body temperature or late-stage contraception) and in vitro ejaculation are substandard methods of contraception.