Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21 (RECEL)

Inclusion Criteria:

• NSCLC confirmed by histopathology or cytology;
• Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung Staging Standard version 7 2009, and be unresectable;
• Has active mutation of EGFR in exon 19 or 21;
• Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
• expectancy life >= 12 weeks;

Exclusion Criteria:

• Had be treated by HER-targeting agents;
• Had systemic anit-NSCLC treatments;
• Had local radiotherapy for NSCLC;
• Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
• Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
• Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
• Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI) agents or relevant components in the formulation;
• Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;