NCT04619563

A Trial of Anlotinib Combined With Docetaxel in EGFR Mutations Advanced Non Small Cell Lung Cancer Patients

A Single-arm Exploratory Clinical Study of Anlotinib Hydrochloride Combined With Docetaxel in EGFR Mutations Advanced Non Small Cell Lung Cancer Patients Who Have Progressed After Targeted Therapy and Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit angiogenesis-related kinases, such as VEGFR, FGFR, PDGFR and tumor cell proliferation related kinase c-Kit kinase. In the Phase III study, patients who failed at least two systemic chemotherapy (third-line or above) or were intolerant of the drugs were treated with anlotinib or placebo. The PFS and OS in the anlotinib group were 5.37 months and 9.63 months, respectively. The placebo group PFS and OS were 1.4 months and 6.3 months. Therefore, it is envisaged to use anlotinib combined with docetaxel to treat EGFR mutations advanced non small cell lung cancer to further improve the patient's PFS or OS.

Detailed description

This is a single arm clinical trial conducted in China. The purpose of this study is to evaluate and observe the efficacy and safety of Anlotinib Hydrochloride (12mg, QD PO d1-14, 21days per cycle) combined with Docetaxel (75mg/m2 IV d1) in EGFR mutations advanced non small cell lung cancer patients who have progressed after targeted therapy and chemotherapy. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. The expected sample size is 42.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib Hydrochloride plus Docetaxel	Anlotinib Hydrochloride (12mg, QD PO d1-14, 21days per cycle) and Docetaxel (75mg/m2 IV d1)

Timeline

• Start date: 2020-11-04
• Primary completion: 2021-10-01
• Completion: 2022-10-01
• First posted: 2020-11-06
• Last updated: 2020-11-18

Locations

1 site across 1 country: China