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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Non-Small Cell Lung Cancer Stage III

Intervention / Treatment
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* Drug: Anlotinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anlotinib<br>Anlotinib p.o, qd. Treatment from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) to disease progress or untolerated toxicity or consent withdrawal. The 2:1 ratio (Anlotinib to blank). | Drug: Anlotinib<br>* Anlotinib 12mg p.o, qd<br>* Other names: AL3818;|
| No Intervention: Blank<br>No intervention from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) .The 2:1 ratio (Anlotinib to blank). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Estimated to be from baseline up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate at 6 months(DCR6) | the percentage of patients with response of Complete Response (CR) or partial response (PR) or stable disease(SD) at least 4 weeks at 6 months after randomization | Estimated to be from baseline up to 3 years | 
| Disease Control Rate at 12 months(DCR12) | the percentage of patients with response of Complete Response (CR) or partial response (PR) or stable disease(SD) at least 4 weeks at 12 months after randomization | Estimated to be from baseline up to 3 years | 
| Overall Survival at 12 months (OS12) | the percentage of patients who are alive at 12 months after randomization per the Kaplan-Meier estimate of overall survival at 12 months | Estimated to be from baseline up to 3 years | 
| Overall Survival at 24 months (OS24) | the percentage of patients who are alive at 24 months after randomization per the Kaplan-Meier estimate of overall survival at 24 months | Estimated to be from baseline up to 3 years | 
| Recurrence rate at 12 months | the percentage of patients with Progressive Disease(PD) at 12 months after randomization | Estimated to be from baseline up to 3 years | 
| Recurrence rate at 24 months | the percentage of patients with Progressive Disease(PD) at 24 months after randomization | Estimated to be from baseline up to 3 years |