drugset
drugset / Trial / NCT05685550

Safety and Efficacy Analysis of Oral Etoposide Combined With Anlotinib and Envafolimab in First-line Treatment of Elderly Patients With Small Cell Lung Cancer/ Open-label, Single-arm, Exploratory Phase II Clinical Study

NCT05685550 ↗

Phase 2 Active not recruiting 30 enrolled Tianjin Medical University Cancer Institute and Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study aims to explore the safety and efficacy of etoposide capsules combined with Anlotinib and Envafolimab in elderly patients with extensive small cell lung cancer.This is a single-center, single-arm exploratory clinical study. 30 patients with extensive small-cell lung cancer are scheduled to be enrolled. Treatment regimen is etoposide capsule 100mg PO qd\*7d, Anlotinib 12mg PO qd\*14d, Envafolimab 300mg/ IH Q3W. Based on the safety and other data from the subjects, the combination regimen was administered for 4 to 6 cycles, with a maximum of 6 cycles. In principle, at least 4 cycles were required unless chemotherapy-related toxicity necessitated early termination. Subsequently, patients without evidence of disease progression received maintenance therapy with envolumab plus anlotinib until disease progression, intolerable adverse events, or death.

Timeline

Start
2023-04-12
Primary completion
2025-12-31
Completion
2026-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Catequentinib Small molecule 12 mg Oral
Subject Envafolimab Monoclonal antibody 300 mg Other
Subject Etoposide Small molecule 100 mg Oral

Indications

No indication recorded.