This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of combination of gefitinib and doublet chemotherapy or antiangiogenesis in advanced non-small cell lung cancer patients with EGFR activating mutation, accompanied with Bim deletion or low activating EGFR mutation abundance.
Name: Gefitinib
Description: Patients received Gefitinib 250mg Qd orally until disease progression, intolerable toxicity or death.Type: DrugGefitinib combined with antiangiogenesis Gefitinib combined with chemotherapy Gefitinib single agent
Name: pemetrexed or gemcitabine plus carboplatin,
Description: doublet chemotherapy with pemetrexed or gemcitabine plus carboplatin per 3 weeksType: DrugGefitinib combined with chemotherapy
Name: bevacizumab
Description: bevacizumab 7.5mg/kg intravenously per 3 weeksType: DrugGefitinib combined with antiangiogenesis
Description: From start of anti-cancer therapy untill progression or death
Measure: Progression free survival Time: 8 weeksDescription: evaluated in the 36th since treatment begain
Measure: overall survival Time: 36 monthsDescription: toxicities related to anti-cancer therapy
Measure: side effect Time: 8 weeksDescription: evaluated since treatment began
Measure: quality of life Time: 24 monthsAllocation: Randomized
Parallel Assignment
There is one SNP
Inclusion Criteria: - Histologically documented, locally advanced or recurrent (stage IIIb and not amenable to combined modality treatment) or metastatic (stage IV) non-small cell lung cancer, anti-cancer treatment naiive - EGFR exon 19 deletion or exon 21 L858R. --- L858R ---
- Bim deletion by realtime PCR, or low abundance for EGFR mutation, for 19Del less than 4.9%, for L858R less than 9.5%. --- L858R ---
- Unhealed bone fracture or wound for long time Inclusion Criteria: - Histologically documented, locally advanced or recurrent (stage IIIb and not amenable to combined modality treatment) or metastatic (stage IV) non-small cell lung cancer, anti-cancer treatment naiive - EGFR exon 19 deletion or exon 21 L858R. --- L858R ---