CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 219 enrolled
Drug / intervention
Gefitinib +1 moredrug
Likely dose
Gefitinib 250mgfrom record
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Search/NCT01404260
NCT01404260Phase 3Completed

Intercalating and Maintenance Use of Iressa vs. Chemotherapy in Selected Advanced NSCLC: a Randomised Study

Guangdong Association of Clinical Trials·interventional·Posted Jul 28, 2011·Updated Jan 27, 2017

In Brief

A Phase 3 clinical trial evaluating Gefitinib and Gemcitabine +Carboplatin for Non-small Cell Lung Cancer. Completed, enrolled 219 participants across 1 site.

Detailed 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 .

Study Details

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 28, 2011
Enrollment StartJun 1, 2011
Primary CompletionMar 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.9 years ago

Interventions

Gefitinibdrug

Gefitinib 250mg/d every cycle d15-25,and Gefitinib 250mg/d from d15 of last cycle until disease progression

Gemcitabine +Carboplatindrug

Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles