Rh-Endostatin Combined With CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A Study to Assess the Effects of Durvalumab following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) in Patients with Stage III Unresectable Non-Small Cell Lung Cancer who can not tolerate 60 Gy irradiation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Chest Hospital
• Collaborator: Wuhan University
• Treatments: Durvalumab; Endostar protein; Endostatins

Criteria

Inclusion Criteria:

• Age at 18-75 years.

• Documented evidence of NSCLC (locally advanced, unresectable, Stage III)

• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)

• Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1.

• Estimated life expectancy of more than 12 weeks.

Exclusion Criteria:

• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.

• Active or prior autoimmune disease or history of immunodeficiency.

• Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.

• Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.

• Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.

• Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).