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

Shanghai Jiao Tong University

Status and phase

Unknown

Phase 4

Conditions

Lung Cancer

Treatments

Radiation: Thoracic irradiation of 50 Gy with 3DCRT or IMRT

Drug: Recombinant human endostatin (Endostar)

Study type

Interventional

Funder types

Other

Identifiers

NCT04613284

CXW001

Details and patient eligibility

About

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.

Full description

A Phase II, Single-arm, Multi-centre Study of Durvalumab as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) Therapy (Relief)

Enrollment

97 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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).