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

Non-Small Cell Lung Cancer Stage III Clinical Trial

— ALTER-L029  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743129
• Other study ID #: 2018YJZ47
• Status: Completed
• Phase: Phase 2
• Start date: April 12, 2019
• Est. completion date: November 11, 2021

Study information

• Verified date: June 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 11, 2021
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer Stage III

Intervention

Drug:
• Anlotinib
Anlotinib 12mg p.o, qd

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The second hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (3)

Lead Sponsor	Collaborator
Anhui Shi, MD	Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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