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ACTIVE NOT RECRUITING
NCT05685550
PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-04-12

Completion Date

2026-05-31

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

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.

Locations (1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, China