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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study was to explore the safety and median PFS of etoposide capsules combined with Anlotinib and Envafolimab as first-line treatment in elderly patients with extensive small-cell lung cancer (as assessed by the investigators according to RECIST 1.1 criteria).The secondary objective of this study was to evaluate the OS, ORR, and QOL of etoposide capsules combined with Envafolimab and Anlotinib as first-line treatment in elderly patients with extensive small-cell lung cancer.Exploratory aims are to explore predictive or prognostic biomarkers (tissue and/or plasma) associated with therapeutic response or resistance to disease; Analysis of potential biomarkers in biopsy tissue samples and blood samples after disease progression to explore possible mechanisms of therapeutic resistance. To provide a better treatment plan for elderly patients with extensive small cell lung cancer.

Conditions

• Progression Free Survival(PFS)

Interventions

Type	Name	Description
DRUG	Toposide capsules combined with Anlotinib and Envafolimab group	Elderly patients with extensive SCLC were given etoposide capsules 100mg PO qd\*7d and Envafolimab 300mg/ time IH Q3W in combination with Anlotinib 12mg PO qd\*14d. 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 Envafolimab plus Anlotinib until disease progression, intolerable adverse events, or death.

Timeline

• Start date: 2023-04-12
• Primary completion: 2025-12-31
• Completion: 2026-05-31
• First posted: 2023-01-17
• Last updated: 2026-02-05

Locations

1 site across 1 country: China