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

Phase 4

• Conditions: Lung Cancer
• Interventions: Drug: Recombinant human endostatin (Endostar); Radiation: Thoracic irradiation of 50 Gy with 3DCRT or IMRT

• Registration Number: NCT04613284
• Lead Sponsor: Shanghai Chest Hospital

Brief 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.

Detailed 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)

Study Timeline

• Study First Submitted: 2020-08-18
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03
• Study Start: 2020-12-01
• Primary Completion: 2022-02
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 97

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endostar combined Radiation	Thoracic irradiation of 50 Gy with 3DCRT or IMRT	-
Endostar combined Radiation	Recombinant human endostatin (Endostar)	-

Primary Outcome Measures

Name	Time	Method
adverse events (AE)	5 years from patient enrollment	Number of participants with adverse events as assessed by CTCAE v5.0
Progression Free Survival	up to approximately 3 years	PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter up to 3 three years	ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
Overall Survival	up to 5 years from patient enrollment	OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.