This is an open-label, multicenter, randomized, phase II clinical trial, which aims to evaluate the effectiveness and safety of gefitinib versus combination of gefitinib and doublet chemotherapy or apatinib in advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) activating mutation (exon 19 deletion or exon 21 L858R point mutation), accompanied with Bim deletion or low activating EGFR mutation abundance.
Name: gefitinib combined with chemotherapy
Name: gefitinib combined with apatinib
Name: gefitinib single agent
Description: From start of anti-cancer therapy until progression or death
Measure: Progression free survival Time: 8 weeksDescription: evaluated in the 36th since treatment begain
Measure: overall survival Time: 36 monthsDescription: Evaluated the rate of complete response and partial response in the 8 weeks since treatment began
Measure: objective response rate Time: 8 weeksDescription: Evaluated the rate of complete response,partial response and stable disease in the 8 weeks since anti-cancer therapy
Measure: disease control rate Time: 8 weeksDescription: interval between the time which complete response or partial response happened and progressive disease or death
Measure: duration of response Time: 8 weeksDescription: Safety observation indexes were listed as following: adverse events and serious adverse events (according to CommonTerminology Criteria Adverse Events Version 4.03), physical exam, vital signs(blood pressure, heart rate, respiratory rate,body temperature), weight variation, laboratory examination(hematology, blood biochemistry, urinalysis and so on), electrocardiograph(ECG),ultrasonic cardiogram(UCG), ect.
Measure: safety evaluation Time: 8 weeksDescription: Quality of Life Questionnaire(including QLQ-C30 and QLQ-LC13) evaluated since treatment began.At the end of the trial, the differences between the two indicators were compared with Mixed-effects model repeated measures (MMRM), where the baseline was scored as a covariant and the treatment group as a fixed variable. In addition, the baseline values of the two scores, the value of each visit, and the change value of the baseline were statistically described.
Measure: compare quality of life Time: 24 monthsAllocation: Randomized
Parallel Assignment
There is one SNP
Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance This is an open-label, multicenter, randomized, phase II clinical trial, which aims to evaluate the effectiveness and safety of gefitinib versus combination of gefitinib and doublet chemotherapy or apatinib in advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) activating mutation (exon 19 deletion or exon 21 L858R point mutation), accompanied with Bim deletion or low activating EGFR mutation abundance. --- L858R ---
3. EGFR mutation (exon 19 deletion or exon 21 L858R) with Bim deletion or low abundance for EGFR mutation. --- L858R ---