Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer（ALTER-L029）
- Registration Number
- NCT03743129
- Lead Sponsor
- Anhui Shi, MD
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anlotinib 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).
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Estimated to be from baseline up to 3 years the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
- Secondary Outcome Measures
Name Time Method Overall Survival at 24 months (OS24) Estimated to be from baseline up to 3 years the percentage of patients who are alive at 24 months after randomization per the Kaplan-Meier estimate of overall survival at 24 months
Disease Control Rate at 12 months(DCR12) Estimated to be from baseline up to 3 years 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
Overall Survival at 12 months (OS12) Estimated to be from baseline up to 3 years the percentage of patients who are alive at 12 months after randomization per the Kaplan-Meier estimate of overall survival at 12 months
Recurrence rate at 12 months Estimated to be from baseline up to 3 years the percentage of patients with Progressive Disease(PD) at 12 months after randomization
Disease Control Rate at 6 months(DCR6) Estimated to be from baseline up to 3 years 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
Recurrence rate at 24 months Estimated to be from baseline up to 3 years the percentage of patients with Progressive Disease(PD) at 24 months after randomization
Trial Locations
- Locations (4)
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The second hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China