After the second-line treatment of patients with non-T790M mutations, chemotherapy with platinum-containing drugs was used, and chemotherapy-related toxicity was high. Studies have shown that bevacizumab combined with EGFR TKI have a good trend of benefit. This study is aimed to evaluate the efficacy and safety of Anlotinib Hydrochloride combined with first-generation EGFR TKIs as second-line treatment in advanced non-small cell lung cancer . The patients with IV non-small lung cancer have acquired resistance to prior first-generation EGFR TKIs and have non-T790M mutation.
Name: Anlotinib Hydrochloride
Description: Capsule, P.O. 12mg qd ,days 1-14, 21 days a cycleType: DrugAnlotinib Hydrochloride plus gefitinib or icotinib
Name: Gefitinib
Description: Tablet, P.O. 250mg qdType: DrugAnlotinib Hydrochloride plus gefitinib or icotinib
Name: Icotinib
Description: Tablet, P.O. 125mg tidType: DrugAnlotinib Hydrochloride plus gefitinib or icotinib
Description: PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Measure: PFS(Progress free survival) Time: each 42 days up to PD or death(up to 24 months)Description: OS is defined as the time until death due to any cause.
Measure: Overall Survival (OS) Time: From randomization until death (up to 24 months)Description: ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
Measure: Objective Response Rate (ORR) Time: each 42 days up to intolerance the toxicity or PD (up to 24 months)Description: use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life.
Measure: Quality of Life(QoL) Time: each 42 days up to intolerance the toxicity or PD (up to 24 months)Description: Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Measure: Disease Control Rate (DCR) Time: each 42 days up to intolerance the toxicity or PD (up to 24 months)Single Group Assignment
There are 2 SNPs
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. - Previously, EGFR gene test showed EGFR exon 19 deletion or exon 21 (L858R) mutation, and the gene test showed no T790M mutation before enrollment. --- L858R ---
A Prospective, Single-arm, Multicenter Study of Anlotinib Hydrochloride Combined With First-generation EGFR TKIs as Second-line Treatment in Acquired (Non-T790M Mutation) Resistance Advanced Non-small Cell Lung Cancer. --- T790M ---
Anlotinib Hydrochloride Combined With EGFR TKIs in Advanced Non-small Cell Lung Cancer After the second-line treatment of patients with non-T790M mutations, chemotherapy with platinum-containing drugs was used, and chemotherapy-related toxicity was high. --- T790M ---
The patients with IV non-small lung cancer have acquired resistance to prior first-generation EGFR TKIs and have non-T790M mutation. --- T790M ---
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. - Previously, EGFR gene test showed EGFR exon 19 deletion or exon 21 (L858R) mutation, and the gene test showed no T790M mutation before enrollment. --- L858R --- --- T790M ---
- Patients that cannot detect EGFR gene, or patients with known T790M mutation. --- T790M ---