NCT04684017

Anlotinib Plus Etoposide and Carboplatin as First-line Treatment for Extensive-stage Small Cell Lung Cancer

Anlotinib Plus Etoposide and Carboplatin as First-line Treatment for Extensive-stage Small Cell Lung Cancer: A Single Arm Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open-label, single center study, aiming to investigate safety and efficacy of etoposide and carboplatin (administered intravenously) in combination with anlotinib (administered orally) in treatment-naive advanced NSCLC.

Detailed description

Lung cancer can be divided into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), of which SCLC accounts for about 15%-20%.Because of the high degree of malignancy of SCLC, patients often lose the opportunity of surgical treatment due to metastasis at the time of admission. Traditional cytotoxic drugs can improve the prognosis of patients and life treatment, but the survival benefit is very limited. Vascular targeted therapy is an important treatment strategy for metastatic lung cancer.Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor that has significant inhibitory activity against angiogenesis related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor related kinases such as PDGFR /, C-Kit, Ret, etc. (e.g., Met, FGFR1/2/3). An exploratory phase II study explored the efficacy of third-line single-drug therapy for ED-SCLC and found significant improvement in prognosis. Based on the above status and research results, the purpose of this study was to explore the efficacy and safety of anlotinib hydrochloride combined with etoposide/carboplatin in first-line treatment of extensive small-cell lung cancer.

Conditions

• SCLC
• Anlotinib

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride	anlotinib 10 mg/day orally (from days 1 to 14 in a 21-day cycle)
DRUG	Etoposide	100mg/m2 iv on days 1-3 every 21 days for 4 cycles
DRUG	Carboplatin	AUC 5 iv on day 1 every 21 days for 4 cycles

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-09-01
• Completion: 2022-01-01
• First posted: 2020-12-24
• Last updated: 2020-12-24

Locations

1 site across 1 country: China