Non-Small Cell Lung Cancer Stage III
Conditions
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.
Interventions
DRUGAnlotinib
Anlotinib 12mg p.o, qd
Sponsors
Peking University Cancer Hospital & Institute
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Anhui Shi, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 12 months | Estimated to be from baseline up to 3 years | the percentage of patients with Progressive Disease(PD) at 12 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 |
| 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 |
Countries
China
Outcome results
None listed