chemotherapy and erlotinib for lung cancer with low abundance epidermal growth factor receptor mutation

Conditions: Non-small-cell Lung Cancer

Summary: this is a single arm phase ii clinical trial, which aims to evaluate the effectiveness of intercalated combination of doublet chemotherapy of paclitaxel plus carboplatin and erlotinib on patients with advanced stage non-small-cell lung cancer with low abundant activating egfr mutation.

primary therapy stage: paclitaxel patients receive six cycles of paclitaxel (175 mg/m² on days 1 of a 4 week cycle, intravenously) plus carboplatin (auc=5, intravenously on day 1 of a 4 week cycle, intravenously) with sequential erlotinib (150 mg/day) on days 8-21 of each cycle. maintenance therapy stage: patients, who complete 6 cycles of therapy without progression or intolerable toxicity, receive erlotinib (150 mg/day) as maintenance therapy until progression, intolerable toxicity or death.

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.

Keywords: non-small cell lung cancer erlotinib chemotherapy