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Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance

Non-small-cell Lung Cancer Clinical Trial

Official title:
Gefitinib Versus Combination of Gefitinib With Chemotherapy or Anti-angiogenesis as 1st Line Treatment in Advanced NSCLC Patients Detected With Bim Deletion or Low EGFR Activating Mutation Abundance：A Randomized, Multicentre, Phase II Study

Clinical Trial Summary

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.

Clinical Trial Description

BIM (bcl-2 interacting mediator of cell death) deletion polymorphism and low EGFR mutation abundance were poor clinical response markers to epidermal growth factor receptor tyrosine kinase inhibitors (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 above risk factors.

Advanced EGFR mutated NSCLC Patients with Bim deletion or EGFR low mutation abundance were randomized divided into following three treatment groups:

A: gefitinib 250mg Qd combined with doublet chemotherapy: pemetrexed (500mg/m²，day 1 ，intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days.

B: gefitinib 250mg Qd combined with apatinib 250mg/d intravenously per 21 days. C: gefitinib 250mg Qd ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03267654
Study type Interventional
Source Qilu Pharmaceutical Co., Ltd.
Contact Caicun Zhou, MD
Phone +8613301825532
Email caicunzhoudr@163.com
Status Recruiting
Phase Phase 2
Start date October 12, 2017
Completion date December 30, 2021
View Details
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