Clinical trial NCT03743129: Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer（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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer Stage III
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Peking University Cancer Hospital & Institute
name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
First posted: 2018-11-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Estimated to be from baseline up to 3 years
Secondary outcomes:
measure: Disease Control Rate at 6 months(DCR6)
timeFrame: Estimated to be from baseline up to 3 years
measure: Disease Control Rate at 12 months(DCR12)
timeFrame: Estimated to be from baseline up to 3 years
measure: Overall Survival at 12 months (OS12)
timeFrame: Estimated to be from baseline up to 3 years
measure: Overall Survival at 24 months (OS24)
timeFrame: Estimated to be from baseline up to 3 years
measure: Recurrence rate at 12 months
timeFrame: Estimated to be from baseline up to 3 years
measure: Recurrence rate at 24 months
timeFrame: Estimated to be from baseline up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Shijiazhuang
country: China
facility: The second hospital of Hebei Medical University
state: Hebei
Study officials:
References: