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A Study of Envafolimab in Subjects With Stage III Non-Small Cell Lung Cancer

Non-small Cell Lung Cancer Stage III Clinical Trial

Official title:
A Prospective, Single-arm Clinical Study of Envafolimab as Consolidation Therapy in Patients With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Has Not Progressed After Concurrent/Sequential Chemoradiotherapy

Clinical Trial Summary

This is a prospective, single arm, phase II study to evaluate the efficacy and safety of Envafolimab in subjects with locally advanced/unresectable (Stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.

Clinical Trial Description

Trial design: This is a single-arm, open-label trial in patients with locally advanced/unresectable (stage III) NSCLC who did not have disease progression after concurrent/sequential chemoradiotherapy to evaluate the efficacy of Envafolimab as a consolidation treatment of the efficacy and safety. Background:The PACIFIC and GEMSTONE-301 studies have shown the efficacy of immunization as consolidation therapy in stage III NSCLC. Patients with stage III NSCLC who did not have disease progression after at least two cycles of concurrent/sequential chemoradiotherapy (including platinum) will receive Envafolimab (300mg, Q3W, subcutaneous injection) within 1-42 days after the end of chemoradiotherapy. The maximum duration of Envafolimab treatment is 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05414630
Study type Interventional
Source Anhui Provincial Cancer Hospital
Contact Yue-Yin Pan, PhD
Phone 0551-62282236
Email yueyinpan1965@126.com
Status Not yet recruiting
Phase Phase 2
Start date June 2022
Completion date June 2025
View Details
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