NCT03602027

Phase I Study of the Combination of Anlotinib With Gefitinib

Dose Climbing Trial of Anlotinib Plus Gefitinib in the First-line Treatment of Advanced Gene Positive Non-squamous Non-small Cell Lung Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Second Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to evaluate the tolerability and toxicity of different dose of Anlotinib puls Gefitinib in First-line Treatment of Advanced Gene Positive Non-squamous Non-small Cell Lung Cancer , to provide a reference of dosage for Phase II clinical trials

Detailed description

This is a randomized, single -center study conducted in China to compare the tolerability and toxicity of different dose of Anlotinib Plus Gefitinib in patients of Advanced GenePositive Non-squamous Non-small Cell Lung Cancer.From low dose group up to high dose group, each one had 3 patients at least.Primary group received anlotinib 8mg. The dose of Anlotinib would increase gradually until MTD. Eligible patients were instructed to take Gefitinib 250mg orally daily for three weeks and 8mg/10mg/12mg Anlotinib orally daily on day 1 to 14 of a 21-day cycle.

Conditions

• Non-squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib	Anlotinib 8mg p.o. qd in low-dose groups (3 subjects). 10mg p.o. qd in middle-dose groups (3 subjects). 12mg p.o. qd in high-dose groups (3 subjects).
DRUG	Gefitinib	Gefitinib 250mg orally daily for three weeks

Timeline

• Start date: 2018-08-01
• Primary completion: 2018-12-01
• Completion: 2019-02-01
• First posted: 2018-07-26
• Last updated: 2018-07-26