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

Anhui Shi, MD90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer Stage III

Interventions

AnlotinibDRUG

Anlotinib 12mg p.o, qd

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (4)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The second hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)