Intercalating and Maintenance Gefitinib in Combination With Chemotherapy for Advanced EGFR-mutant NSCLC
Status:
Terminated
Trial end date:
2017-10-01
Target enrollment:
Participant gender:
Summary
Study Title:
Intercalating and maintenance Gefitinib in combination with chemotherapy (gemcitabine plus
carboplatin) as first-line treatment for patients with advanced EGFR mutation-positive
non-small cell lung cancer: A randomized, open-label, multiple-centre study.
Target population-Treatment naive EGFR mutant-positive advanced NSCLC patients.
Study Objectives - Primary Study Objective: To investigate whether intercalating and
maintenance Gefitinib in combination with chemotherapy improve the Progression-Free Survival
(PFS) vs. Gefitinib alone in advanced NSCLC with EGFR activating mutation.
- Secondary Study Objective： To evaluate whether intercalating and maintenance Gefitinib in
combination with chemotherapy improve the Objective Response Rate (ORR), Disease control rate
(DCR), Overall survival (OS), 2-year OS rate, QOL vs. Gefitinib alone.
Evaluation the safety of Intercalating and Maintenance Gefitinib in combination with
chemotherapy.
- Exploratory objective: PFS of arm A vs. PFS 1 + PFS 2 of arm B Dynamic biomarker analysis
using blood sample
a: The PFS 1 of arm B is the time from randomization to disease progression of 1st-line
therapy or death from any cause, whichever occurs first. The PFS 2 of arm B is the time from
the time of PFS 1 to disease progression of 2nd-line therapy or death from any cause,
whichever occurs first.
Study Design-Prospective, open-label, randomized, multi-center study.