Non-small Cell Lung Cancer Clinical Trial
Official title:
Intercalating and Maintenance Use of Iressa vs. Chemotherapy in Selected Advanced NSCLC: a Randomised Study
Platinum-based combination chemotherapy, such as gemcitabine-carboplatin, is one of the
standard first-line therapy for advanced non-small cell lung cancer (NSCLC).
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) have clinical
efficacy, as compared with the best supportive care or standard chemotherapy, when given as
second-line or third-line therapy for advanced NSCLC.
Treatment with EGFR-TKI is most effective in female, never-smoker, or patients with
adenocarcinoma, and patients of Asian origin. In these populations, such treatment is
associated with favorable objective response rates, progression-free survival, and overall
survival. These populations also have a relatively high incidence of somatic mutations in
the region of the EGFR gene that encodes the tyrosine kinase domain.
The recent study(IPASS) by Tony S. Mok showed gefitinib was superior to
carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers
or former light smokers in East Asia . In the subgroup of 261 patients who were positive for
the EGFR gene mutation, PFS was significantly longer among those who received gefitinib than
among those who received carboplatin-paclitaxel(HR= 0.48,P<0.001), whereas in the subgroup
of 176 patients who were negative for the mutation, PFS was significantly longer among those
who received carboplatin-paclitaxel(HR=2.85,P<0.001). Gefitinib treatment was well
tolerated, with lower in hematologic toxicity, and no treatment-related interstitial lung
disease.In this study(IPASS), only patients with a mutation of the EGFR gene in the tumor
could get benefit from gefitinib as first line treatment.
Tony S. Mok and his colleague also found that intercalating and maintenance administration
of erlotinib(another EGFR-TKI)following gemcitabine/platinum chemotherapy as first line
therapy led to a significant improvement in PFS .
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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