A Phase II Study on the Safety and Efficacy of Radiation Therapy and Concurrent Erlotinib in Locally Advanced Non-small-cell Lung Cancer
Non-small cell lung cancer (NSCLC) is still the leading cause of cancer death world-wide.
Radiation therapy (RT) is one of the most important treatment choices in locally advanced
NSCLC. Combination of RT and chemotherapy could improve treatment outcomes. However, the
combined modality could not be used in many patients due to severe toxicities. EGFR-TKI
shows great efficacy in the treatment of NSCLC, and many phase I/II studies established its
safety in combination with RT. This phase II study is to further evaluate the efficacy and
safety of the combination of RT and erlotinib in the treatment of locally advanced NSCLC.
Eligible patients include patients with stage IIIA/IIIB NSCLC, who are not suitable for or
refused to receive concurrent chemoradiotherapy. Eligible patients will receive oral
erlotinib (150mg qd)throughout the course of thoracic RT (60-70 Gy). The primary endpoint is
progression free survival and the second endpoints are overall survival and any grade III
and above toxicities. We are going to recruit 50 patients for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evidence of clinically definite disease progression
Zhiyong Yuan, M.D., Ph.D.
Tianjin Medical University Cancer Institute and Hospital
China: Ethics Committee