Intercalating and Maintenance Use of Iressa Versus Chemotherapy in Selected Advanced Non Small Cell Lung Cancer
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
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 .
Phase:
Phase 3
Details
Lead Sponsor:
Guangdong Association of Clinical Trials
Collaborators:
Changhai Hospital First Hospital of Jilin University First People's Hospital of Hangzhou Fudan University Henan Cancer Hospital Jiangsu Cancer Institute & Hospital NanJing PLA 81 Hospital Nanjing PLA General Hospital Ruijin Hospital Second Affiliated Hospital, School of Medicine, Zhejiang University Sir Run Run Shaw Hospital The First Affiliated Hospital of Soochow University The First Hospital of Jilin University Wuxi No. 4 People's Hospital