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

Lung Cancer Clinical Trial

— RELIEF  

Official title:

Rh-Endostatin Combined With Low-dose CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC Who Can Not Tolerate 60 Gy Irradiation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04613284
• Other study ID #: CXW001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: August 2023

Study information

• Verified date: October 2020
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 97
• Est. completion date: August 2023
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Drug:
• Recombinant human endostatin (Endostar)
Continuous intravenous infusion of endostar (Simcere Pharma- ceutical, Nanjing, China) was made over 120 h before the begin- ning of radiotherapy, and then repeated every two weeks. The dose was 7.5 mg/m2/24 h 120 h, 14 days/cycle. ECG monitoring was performed during the first delivery of endostar.

Radiation:
• Thoracic irradiation of 50 Gy with 3DCRT or IMRT
Concurrent thoracic chemoradiotherapy with reduced irradiation dose of 50 Gy will be given to patients with unresectable stage III NSCLC who can not tolerate irradiation dose to 60 Gy.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	Wuhan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	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).	up to approximately 3 years
Primary	adverse events (AE)	Number of participants with adverse events as assessed by CTCAE v5.0	5 years from patient enrollment
Secondary	Overall Survival	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.	up to 5 years from patient enrollment
Secondary	Objective Response Rate	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.	Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter up to 3 three years