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

Anhui Shi, MD

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer Stage III

Treatments: Drug: Anlotinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03743129

2018YJZ47

Details and patient eligibility

About

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

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Anlotinib

Experimental group

Description:

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).

Treatment:

Drug: Anlotinib

Blank

No Intervention group

Description:

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