NCT06108726

A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer

A Single-arm, Exploratory Clinical Trial Investigating the Efficacy of Local Envafolimab Injection Under Fiberoptic Bronchoscopy Combined With Chemotherapy in Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Northern Jiangsu People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this single-arm, exploratory clinical study is to evaluate the safety and efficacy of local injection of envafolimab combined with chemotherapy in the first-line treatment of non-small cell lung cancer (NSCLC) patients, and to observe the changes of immune cells in the local immune microenvironment before and after immunotherapy, in order to find new indicators for immunotherapy evaluation.

Detailed description

In this study, 16 patients with NSCLC were enrolled to explore the clinical effect of chemotherapy combined with local injection of Envafolimab. To determine whether the treatment of metastatic/recurrent NSCLC with Envafolimab is effective, and whether the treatment of Envafolimab combined with chemotherapy can prolong the PFS\\OS of patients with NSCLC, and to screen for a more effective treatment mode for Chinese NSCLC patients.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Envafolimab Injection	Local injection of Envafolimab 5mg/kg plus platinum-based chemotherapy under fiberoptic bronchoscopy, Q2W.

Timeline

• Start date: 2023-10-18
• Primary completion: 2025-01-18
• Completion: 2025-10-18
• First posted: 2023-10-31
• Last updated: 2023-10-31

Locations

1 site across 1 country: China