NCT04671303

To Evaluate the Efficacy and Safety of Anlotinib Combined With Furmonertinib Mesylate in Lung Cancer

This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined With Furmonertinib Mesylate in First-line Treatment of Advanced No-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in First-line Treatment of Advanced no-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.

Detailed description

This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in First-line Treatment of Advanced No-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation. This study is a single arm, phase II study, including 18 to 36 subjects; Common Terminology Criteria for Adverse Events 5.0 standard was used to evaluate adverse events of drugs, and Response Evaluation Criteria In Solid Tumors 1.1 was used to evaluated efficacy.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate	Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Furmonertinib Mesylate：The dose of Furmonertinib Mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast. Take medicine continuously for 3 weeks (21 days) for 1 cycle.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-06-30
• Completion: 2023-07-27
• First posted: 2020-12-17
• Last updated: 2025-05-11

Locations

1 site across 1 country: China