A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Erlotinib Versus Etoposide Plus Cisplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of Epidermal Growth Factor Receptor (EGFR) in Exon 19 or 21
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;