Chemotherapy concurrent with thoracic radiotherapy (TRT) has been proven effective in extensive stage small-cell lung cancer and stage IV NSCLC. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are the 1st -line standard treatment for stage IV non-small cell lung cancer (NSCLC) harboring active EGFR mutations. Previous in vitro studies showed that EGFR-TKIs could sensitize tumor cells to radiotherapy and some researches indicated that EGFR mutations appear to be a favorable predictive and prognostic factor in NSCLC patients treated with radiotherapy. A retrospective study indicated that the combination of EGFR-TKIs with TRT as the 1st-line treatment was effective. However, there is no prospective data to confirm the efficacy of Erlotinib with concurrent TRT in stage IV EGFR mutant NSCLC patients. The objective of this study is to investigate the efficacy and safety of erlotinib with concurrent TRT as the 1st-line treatment in these patients.
This is a prospective single-arm, open-label, phase II study. Previously untreated NSCLC patients with EGFR active mutations are enrolled and treated with erlotinib (150 mg per day) in combination with concurrent TRT (pGTV 54-60Gy / 27-30F / 5.5-6w) within 2 weeks. Inclusion criteria include aged 18-75 yrs, ECOG PS 0-2, stage IV and less than 10 distant lesions. The major exclusion criteria include previous anti-tumor therapy, extrapulmonary radiotherapy, acute or chronic infectious diseases and allergy to erlotinib. A total of 47 NSCLC patients who are pathologically confirmed at stage IV are needed. The primary endpoint is 1-year rate of PFS. Up to July 30th, 2015, five participants have been enrolled. The study was registered in clinicaltrials.gov (NCT 02353741).
Clinical trial identification
All authors have declared no conflicts of interest.