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Spots Global Cancer Trial Database for A Study of Envafolimab in Subjects With Stage III Non-Small Cell Lung Cancer

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Trial Identification

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

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

Study ID: NCT05414630

Interventions

Envafolimab

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Anhui Provincial Cancer Hospital, Hefei, Anhui, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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