At present, with the increasing intensities of the tobacco industry and air pollution in China, the incidence and mortality of lung cancer have become the most important issue that threatens human health.Over the past two decades, the treatment of EGFR+ NSCLC is molecular target therapy (EGFR-TKI). However, only about 30 percent patients with T790M mutation could accept 3rd generation of EGFR-TKI(AZD9291) , most of the patients with progressive disease statuses still stays in the mode of treatment based on radiotherapy and chemotherapy. This is a prospective, single-center, one-arm clinical study designed to evaluate the efficacy and safety of apatinib plus chemotherapy for 30 patients who progressed after EGFR-TKI treatment without T790M mutation. The participants will receive apatinib 250mg qd orally combine with chemotherapy, if the patient has a grade 3/4 adverse reaction during such treatment, it can be reduced to apatinib 250mg orally once per two days. Chemotherapeutic agents are limited to platinum-based double drugs chemotherapy.The primary outcome endpoint was progression-free survival.
Name: Apatinib
Description: 30 patients who progressed after EGFR-TKI treatment without T790M mutation will receive apatinib 250mg qd orally combine with chemotherapy , if the patient has a grade 3/4 adverse reaction during such treatment, apatinib should be reduced to 250mg orally once per two days. Chemotherapeutic agents are limited to platinum-based double drugs(Pemetrexed,Gemcitabine,Docetaxel).Type: DrugPatients who progressed after EGFR-TKI without T790M mutation
Description: Progression-free survival
Measure: PFS Time: One to two yearsDescription: Overall survival
Measure: OS Time: Five yearsDescription: Adverse events
Measure: AEs Time: One yearDescription: Disease control rate
Measure: DCR Time: One yearDescription: Objective response rate
Measure: ORR Time: One yearSingle Group Assignment
There is one SNP
A Prospective, Single-center, One-arm Clinical Study of Apatinib Combined With Chemotherapy for Patients Who Progressed After First Line EGFR-TKI Treatment Without T790M Mutation. --- T790M ---
Apatinib Combined With Chemotherapy for NSCLC Patients Without T790M Mutation At present, with the increasing intensities of the tobacco industry and air pollution in China, the incidence and mortality of lung cancer have become the most important issue that threatens human health.Over the past two decades, the treatment of EGFR+ NSCLC is molecular target therapy (EGFR-TKI). --- T790M ---
However, only about 30 percent patients with T790M mutation could accept 3rd generation of EGFR-TKI(AZD9291) , most of the patients with progressive disease statuses still stays in the mode of treatment based on radiotherapy and chemotherapy. --- T790M ---
This is a prospective, single-center, one-arm clinical study designed to evaluate the efficacy and safety of apatinib plus chemotherapy for 30 patients who progressed after EGFR-TKI treatment without T790M mutation. --- T790M ---
Inclusion Criteria: 1. male or female patients: 18-75 years old; 2. ECOG performance status score: 0~2 points; 3. Non small cell lung cancer patients who progressed after first line EGFR -TKI treatment without T790M mutation 4.Expected survival period ≥12 weeks; 5.The normal function of major organs, that is, the relevant inspection indicators within the first 14 days of randomness, meet the following requirements: 1. Blood tests: 1. Hemoglobin ≥ 90 g/L (without transfusion in 14 days); 2. Neutrophil count ≥ 1.5×109/L; 3. Platelet count ≥ 100×109/L; 2. Biochemical check: a .total --- T790M ---