Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer（ALTER-L029）

A Randomised, Open, Blank-controlled, Multi-centre Study of Anlotinib as Sequential Therapy in Patients With Unresectable NSCLC(Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy

Evaluate the efficacy and safety of Anlotinib following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer

Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.

Inclusion Criteria:

• 1.Age at least 18 years.
• 2.Documented evidence of NSCLC (locally advanced, unresectable, Stage III).
• 3.Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
• 4.ECOG PS : 0 to 1.
• 5.Estimated life expectancy of more than 12 weeks.

Exclusion Criteria:

• 1.Prior exposure to any anti-angiogenesis drugs.
• 2.Central lung carcinoma along with large vessels or tumor with cavum or necrosis.
• 3.Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
• 4.Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
• 5.Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or COPD.