NCT04797806

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

Phase III Study Comparing Anlotinib Plus Icotinib to Icotinib in Patients With Untreated Non-squmous NSCLC Harboring EGFR Concomitant Mutations

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 206 (estimated)
• 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 concomitant 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	Anlotinib 12 mg once a day from day 1 to 14 of a 21-day cycle.
DRUG	Icotinib	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: 2021-03-12
• Primary completion: 2022-04-30
• Completion: 2023-04-30
• First posted: 2021-03-15
• Last updated: 2021-03-15

Locations

1 site across 1 country: China