NCT04675697

Anlotinib Plus Platinum-etoposide in First-line of Extensive-stage Small-cell Lung Cancer

Anlotinib Plus Platinum-etoposide in First-line Treatment of Extensive-stage Small-cell Lung Cancer: a Single-arm Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and tumor cell proliferation. The efficacy of Anlotinib as a third-line or beyond therapy for SCLC was confirmed in the ALTER1202 trial. The aim of this trial was to investigate the prognostic value of Anlotinib plus platinum-etoposide in first-line treatment of extensive-stage SCLC patients.

Detailed description

This single-arm phase II trial enrolled extensive-stage SCLC patients without prior systematic chemotherapy or immunity checkpoint inhibitors therapy at Xiangya hospital, Central South University from Aug 15, 2018 to Oct 7, 2020.The study was done in accordance with the International Conference on Harmonisation good clinical practice guidelines, the Declaration of Helsinki, and applicable local regulations with approval from an independent ethics committee or institutional review boards. Eligible patients were age 18-70 years with histologically confirmed extensive-stage small-cell lung cancer as defined according to the staging standard introduced by the Veterans Administration Lung Study Group (VALG), measurable according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1), and an Eastern Cooperative Oncology Group (ECOG) performance-status (PS) score of 0 or 1, who had not received previous systemic treatment for extensive-stage small-cell lung cancer and were expected survival time ≥3 months. Patients with treated asymptomatic central nervous system (CNS) metastases were eligible under some circumstance (see the Supplementary Appendix). Key exclusion criteria were a history of mixed small cell carcinoma and non-small cell carcinoma and with active central nervous system (CNS) metastasis and/or cancerous meningitis during screenings.

Conditions

• Extensive-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Platinum-etoposide+Anlotinib	Platinum-etoposide regiment consisted of etoposide 100mg/m2, d1\~3 of 21-day cycle, with investigators' choice of either cisplatin (75-80mg/m2, Q3W) or carboplatin (AUC=5\~6, Q3W). Anlotinib treated of 12mg Qd from day 1 to 14 of a 21-day cycle. Eligible patients received anlotinib plus platinum-etoposide for 4\~6 cycles, and followed by maintenance therapy with Anlotinib. The efficacy was evaluated every 6 weeks (2 cycles) through treatment.

Timeline

• Start date: 2019-01-24
• Primary completion: 2020-12-31
• Completion: 2021-01-31
• First posted: 2020-12-19
• Last updated: 2020-12-19

Locations

1 site across 1 country: China