Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC

PHASE4UnknownINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

July 31, 2017

Study Completion Date

July 31, 2017

Conditions
EGFR Positive Non-small Cell Lung CancerAdenocarcinoma
Interventions
DRUG

Sequential and maintenance icotinib

Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, sequential icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib until disease progression or intolerable toxicity.

DRUG

Maintenance icotinib

Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib (125 mg three times per day) until disease progression or intolerable toxicity.

Trial Locations (1)

530021

First Affiliated Hospital of Guangxi Medical University, Nanning

All Listed Sponsors
lead

Betta Pharmaceuticals Co., Ltd.

INDUSTRY