Intercalating and Maintenance Use of Iressa vs. Chemotherapy in Selected Advanced NSCLC: a Randomised Study
Nowadays,EGFR mutation status is unknown for most of the advanced NSCLC patients in
clinical practice.Those patients with high probability of EGFR mutation maybe could get
benefit from gefitinib as first-line treatment. For this reason, the investigators need more
investigation to focus on EGFR mutation unknown patients. In the previous study (including
FAST-ACT), the patients enrolled trial received EGFR-TKI plus chemotherapy nearly
simultaneously,so the investigators could not know whether those patients gained benefit
from EGFR-TKI or chemotherapy, maybe chemotherapy alone was enough. If the patients with
EGFR mutation status unknown could get stable disease(SD) after two cycles of
chemotherapy,those patients may be optimal for the investigation of intercalating and
maintenance administration of gefitinib. The reasons are that chemotherapy may be enough
for those with objective response after two cycles chemotherapy, of course, those with
disease progression (PD) should be excluded from the study.
On the basis of these and other studies, the investigators hypothesized that in a selected
population,first-line chemotherapy(gemcitabine +carboplatin) with intercalating and
maintenance use of gefitinib would be more efficacious than chemotherapy alone. In this
study, the investigators compared the efficacy, safety, and adverse-event profile of
chemotherapy plus gefitinib with those of chemotherapy alone, when these drugs were used as
first-line treatment in nonsmokers or former light smokers in China, who had lung
adenocarcinoma with EGFR gene mutation unknown.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Patients were imaged with computed tomography (CT) scan.
Yilong Wu, MD.
Guangdong Province Clinical Trial Association
China: Food and Drug Administration