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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-05

No results posted yet for this study

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.

Conditions

  • Progression Free Survival(PFS)

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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05685550 on ClinicalTrials.gov