NCT03736837

Study of Anlotinib Combined With Icotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC

A Multi-center, One-arm Clinical Study of Anlotinib Combined With Icotinib as the First-line Treatment in Patients With EGFR Mutation-positive Advanced NSCLC. The Trial Aims to Evaluate the Efficacy and Safety of This Treatment.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy and safety of Anlotinib plus Icotinib as the first-line treatment in patients with sensitive EGFR mutations advanced non-small cell lung cancer.

Detailed description

Anlotinib Hydrochloride is a kind of innovative medicines approved by State Food and Drug Administration（CFDA:2011L00661） which was developed 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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib Plus Icotinib	Anlotinib：12mg/capsule, take once when limosis in the morning. If patients suffer from AEs, they can get declined dosage (10mg or 8mg). Icotinib：125 mg/tablet，three times a day，fasting or serving with food. It should be continued until disease progression or intolerable toxicity or patients withdraw of consent.

Timeline

• Start date: 2018-12-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2018-11-09
• Last updated: 2021-03-15

Locations

5 sites across 1 country: China