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.
BIM deletion polymorphism and low EGFR mutation abundance were poor clinical response markers to EGFR-TKIs in NSCLC patients who had EGFR mutations.This is a phase II clinical trial to investigate the efficacy of combination treatment for patients harboring risk factors. Advanced EGFR mutated NSCLC Patients with Bim deletion or EGFR low mutation abundance were randomizely divided into three treatment groups: A:Gefitinib 250mg Qd B:Gefitinib 250mg Qd combined with doublet chemotherapy: Pemetrexed (500mg/m²day 1 intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days, Gemcitabine (1000 mg/m² days 1, day8, intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days C:Gefitinib 250mg Qd combined with bevacizumab 7.5mg/kg intravenously per 21 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Patients received Gefitinib 250mg Qd orally until disease progression, intolerable toxicity or death.
doublet chemotherapy with pemetrexed or gemcitabine plus carboplatin per 3 weeks
bevacizumab 7.5mg/kg intravenously per 3 weeks
Department of Oncology, Shanghai pulmonary hospital
Shanghai, China
Progression free survival
From start of anti-cancer therapy untill progression or death
Time frame: 8 weeks
overall survival
evaluated in the 36th since treatment begain
Time frame: 36 months
side effect
toxicities related to anti-cancer therapy
Time frame: 8 weeks
quality of life
evaluated since treatment began
Time frame: 24 months
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