Clinical trial NCT02095782 (phase 2, status: terminated)
Conditions: non-small-cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: intercalated combination of chemotherapy and erlotinib
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Reason stopped: 
    because of the very slow enrollment, this study was stopped.
  
Eligibility criteria:

        Inclusion Criteria:Patients with histologically documented, locally advanced or recurrent
        (stage IIIb and not amenable to combined modality treatment) or metastatic (stage IV)
        non-small cell lung cancer.

        Low abundant activating EGFR mutation: EGFR exon 19 deletion or exon 21 L858R, which are
        positive by real-time PCR methods and negative by standard sequencing methods.

        Uncommon EGFR mutations are included excluding exon 20 mutations. ECOG performance status
        of ≤ 2. Patients can administer first line setting of platinum based chemotherapy. Patients
        must have measurable disease according to the RECIST (version 1.1) criteria.

          -  Life expectancy of at least 12 weeks.

          -  Age ≥ 18 years.

          -  Written (signed) informed Consent to participate in the study.

          -  Adequate organ function as defined by the following criteria:

        Liver function: SGOT (AST) and SGPT (ALT) ≤ 2.5 X ULN in the absence of liver metastases or
        up to 5 X ULN in case of liver metastases. Total bilirubin ≤ 1.5ULN.

        Bone marrow function: Granulocyte count ≥ 1,500/mm3 and platelet count ≥100,000/mm3 and
        hemoglobin ≥90g/dl.

        Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min. (based on
        modified Cockcroft-Gault formula).

          -  For all females of childbearing potential a negative serum/urine pregnancy test must
             be obtained within 48 hours before enrollment. Postmenopausal women must have been
             amenorrhoeic for at least 12 months to be considered of non-childbearing potential.

        Exclusion Criteria:Patients with prior chemotherapy or systemic anti-cancer therapy
        including target therapy targeting HER family members (such as erlotinib, gefitinib,
        cetuximab, trastuzumab, etc). Previous adjuvant or neo-adjuvant treatment for
        non-metastatic disease is permitted if completed ≥ 6 months before the enrollments.

          -  Patients with history of any other malignancies within 5 years (except for adequately
             treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).

          -  Patients who have brain metastasis or spinal cord compression. It is permitted if the
             patient has been treated with surgery and/or radiation with evidence of stable disease
             for at least 4 weeks.

          -  Patients who are at risk (in the investigator's opinion) of transmitting human
             immunodeficiency virus (HIV) through blood or other body fluids.

          -  Nursing or lactating women.

          -  Sexually active males and females (of childbearing potential) unwilling to practice
             contraception during the study.

          -  Unwilling to write informed consent to participate in the study.

          -  Patients who is unwilling to accept the follow-up.