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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-12

Study Completion Date

2021-11-11

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

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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.

Conditions

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Non-Small Cell Lung Cancer Stage III

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anlotinib

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).

Group Type EXPERIMENTAL

Anlotinib

Intervention Type DRUG

Anlotinib 12mg p.o, qd

Blank

No intervention from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) .The 2:1 ratio (Anlotinib to blank).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Anlotinib

Anlotinib 12mg p.o, qd

Intervention Type DRUG

Other Intervention Names

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AL3818

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No