NCT04967625

A Phase II Study of Sintilimab Combined With Anlotinib in Treatment of ED-SCLC

Anti-PD-1 Antibody Sintilimab Combined With Anti-angeogensis Inhibitor Anlotinib in Treatment of Extensive-stage Disease Small Cell Lung Cancer After Failure of First Line Standard Therapy : a Single-arm Prospective Phase II Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a the researchers launched, single-center, prospective, open-label, single arm ,Phase II clinical study of Sintilimab combined with anlotinib in patients with extensive-stage disease small-cell lung cancer to evaluate the efficacy and safety. 23 patients are expected to be enrolled in this study.

Detailed description

Subjects will receive sintilimab 200mg, IV, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W treatment until disease progression, unacceptable toxicity, or death.

Conditions

• Small Cell Lung Cancer Extensive Stage

Interventions

Type	Name	Description
DRUG	Sintilimab	A humanized anti-PD-1 monoclonal antibody
DRUG	Anlotinib hydrochloride	A tyrosine kinase inhibitor selectively targeting VEGFR-2

Timeline

• Start date: 2021-07-26
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-07-19
• Last updated: 2021-07-28