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

2018YJZ47

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

2019-04-12

2021-11-11

2021-11-11

Completed

Early phase I

90

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

2023-06-12