There are two different treatment modes for NSCLC patients who failed to epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) after initially responding to EGFR-TKI. One is EGFR-TKI combined with chemotherapy and the other is chemotherapy followed by EGFR-TKI. It is unclear which one is more suitable to this group of lung cancer patients. So this phase Ⅱclinical trial is designed to compare the efficiency and safety of these two different treatment modes.
Name: combined group
Description: chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycle is 6 depending on disease evaluation and patient's physical condition combined with gefitinib 250mg once per day from the start day of chemotherapy until disease progression or intolerable side effects.Type: Drugcombined group
Name: Sequenced group
Description: sequenced group chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycles is 6 depending on disease evaluation or patient's physical condition sequenced by gefitinib 250mg once per day until disease progression or intolerable side effects.Type: Drugsequenced group
Description: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
Measure: progression free survival Time: up to 52 weeks (about one year)Description: From date of randomization until the date of death from any cause, assessed up to 100 weeks.
Measure: overall survival Time: up to 100 weeksDescription: The objective response rate includes the complete remission and partial remission rate.
Measure: objective response rate Time: up to 9 weeksDescription: FACL-L is assessed at different time points.(Date of randomization,1 week after chemotherapy,every cycle of chemotherapy,every month of EGFR-TKI maintain treatment,up to 100 weeks)
Measure: the score of functional assessment of cancer treatment-lung(FACT-L) Time: up to 100weeksDescription: The adverse events are assessed by National Cancer Institute-Common Toxicity Criteria(version3.0) (NCI-CTC).
Measure: Number of participants with adverse events Time: Participants will be followed for the duration of treatment, an expected average of 52 weeks.Allocation: Randomized
Parallel Assignment
There is one SNP
The adverse events are assessed by National Cancer Institute-Common Toxicity Criteria(version3.0) (NCI-CTC).. Inclusion Criteria: - age ≥ 18 years - histologically and cytologically proven non-small cell bronchogenic carcinoma (sputum cytology alone was not acceptable) - clinical stages ⅢB or Ⅳ - recurrent or refractory disease following previous first-line chemotherapy regimens containing platinum and second-line EGFR-TKIs therapy - partial remission (PR) or stable disease (SD) at least for 6 months during previous EGFR-TKI treatment - at least one bidimensionally measurable or radiographically assessable lesion - Eastern cooperative oncology group performance status (ECOG PS) ≤ 2 - life expectancy ≥ 12 weeks - adequate hematological, renal, and hepatic functions Exclusion Criteria: - additional malignancies - uncontrolled systemic disease - any evidence of clinically active interstitial lung disease - newly diagnosed central nervous system (CNS) metastasis and not treated by radiotherapy or surgery - pregnancy or breast feeding phase Inclusion Criteria: - age ≥ 18 years - histologically and cytologically proven non-small cell bronchogenic carcinoma (sputum cytology alone was not acceptable) - clinical stages ⅢB or Ⅳ - recurrent or refractory disease following previous first-line chemotherapy regimens containing platinum and second-line EGFR-TKIs therapy - partial remission (PR) or stable disease (SD) at least for 6 months during previous EGFR-TKI treatment - at least one bidimensionally measurable or radiographically assessable lesion - Eastern cooperative oncology group performance status (ECOG PS) ≤ 2 - life expectancy ≥ 12 weeks - adequate hematological, renal, and hepatic functions Exclusion Criteria: - additional malignancies - uncontrolled systemic disease - any evidence of clinically active interstitial lung disease - newly diagnosed central nervous system (CNS) metastasis and not treated by radiotherapy or surgery - pregnancy or breast feeding phase Non Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Responses to EGFR-TKIs are quiet dramatic and durable, especially in patients with EGFR gene classic mutations, such as 19 deletion or 21 leucine 858 arginine(L858R). --- L858R ---