NCT03700359

A Study of Lobaplatin/Etoposide With or Without Anlotinib Maintenance Therapy in Patients With ES-SCLC

A Randomized, Open-label Study of Lobaplatin/Etoposide as First Line Therapy With or Without Anlotinib Maintenance Therapy in Patients With Extensive-stage Small-cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, open-label and active controlled phase II study. It plans to enroll 60 subjects with extensive stage small cell lung cancer (ES-SCLC). All subjects will be assigned randomly to the experimental arm or control arm. The primary endpoints would be overall survival and progression-free survival.

Detailed description

Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy. SCLC has a more abundant vascular network than NSCLC. Anti-tumor vascular therapy combined with chemotherapy is considered the most promising SCLC first-line anti-tumor strategy. Anlotinib Hydrochloride has an anti-angiogenic effect and inhibits tumor's growth. It has been reported that Anlotinib has the dual benefits of both overall survival and progression-free survival in the treatment of multiple tumors, and has initially demonstrated its safety and efficacy. The ALTER 0303 study results showed that Anlotinib benefited both the overall and progression-free survival of NSCLC patients. However, there is no clinical study to probe its relevance to small cell lung cancer, and few studies have examined the status of Anlotinib in first-line treatment. This randomized, open-label, controlled study is to evaluate the efficacy and safety of sequential EL regimen with Anlotinib hydrochloride as first-line treatment for extensive-stage SCLC. The study plan to enroll 60 ES-SCLC subjects and will provide evidence for the use of Anlotinib for SCLC first-line treatment.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Anlotinib Hydrochloride	Anlotinib: Maintenance therapy 12mg/day P.O., day 1-15 every 21 days (2 weeks on, 1 week off) until progressive disease or treatment discontinuation
DRUG	Lobaplatin	Lobaplatin:30 mg/m2 IV every 21 days for up to 4 cycles of 21 days
DRUG	Etoposide	Etoposide: 60 mg/m2 IV every 21 days for up to 4 cycles of 21 days

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-11-29
• Completion: 2021-11-29
• First posted: 2018-10-09
• Last updated: 2019-11-29

Locations

1 site across 1 country: China