Chemotherapy: Open Access
Open Access

Abstract

A Study Design: Concurrent EGFR-TKI and Thoracic Radiotherapy as Firstline Treatment of Stage IV NSCLC Patients with EGFR Active Mutations (CERTAIN Study)

Yan-Mei Wang, Yu-Zhong Duan, Rong-Xia Liao, Yan Li, Xu Chen and Jian-Guo Sun

Lung cancer is a common malignant tumor with high morbidity and mortality worldwide; more than 70 percent of patients are diagnosed with advanced disease. Nowadays, chemotherapy with concurrent thoracic radiotherapy (TRT) has been proven effective in stage IV NSCLC. Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), such as gefitinib and erlotinib, is the standard first-line treatment for stage IV non-small cell lung cancer (NSCLC) patients harboring EGFR active mutations. Previous in vitro studies showed that EGFR-TKI could sensitize tumor cells to radiation, and some researches indicated that EGFR mutations appear to be favorable predictive and prognostic factors in NSCLC patients treated with radiotherapy. A retrospective study has indicated that the combination of EGFR-TKI with TRT as the first-line treatment for advanced NSCLC was effective. However, the efficacy of this novel combination treatment strategy needs to be further confirmed in a prospective study. This is an open-labeled, single-arm, phase II clinical trial aiming to evaluate the efficacy and safety of EGFR-TKI combined with thoracic radiotherapy as first-line treatment of stage IV NSCLC patients with positive EGFR mutations. We plan to enroll 47 patients not receiving therapy for primary and metastatic disease previously and with cytologically or pathologically confirmed stage IV NSCLC harboring EGFR active mutations. Each patient will receive erlotinib 150 mg per day orally with concurrent TRT (54~60 Gy/27~30 F/5.5~6 w, within 2 weeks from the beginning of enrollment) until disease progression or intolerable toxicities. The study has been initiated since January 2015 and will be finished in December 2017 expectedly.