NCT04613284

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
97

participants targeted

Target at P25-P50 for phase_4 lung-cancer

Timeline
Completed

Started Dec 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

August 18, 2020

Last Update Submit

October 27, 2020

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • adverse events (AE)

    Number of participants with adverse events as assessed by CTCAE v5.0

    5 years from patient enrollment

Secondary Outcomes (2)

  • Overall Survival

    up to 5 years from patient enrollment

  • 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

Study Arms (1)

Endostar combined Radiation

EXPERIMENTAL
Drug: Recombinant human endostatin (Endostar)Radiation: Thoracic irradiation of 50 Gy with 3DCRT or IMRT

Interventions

Recombinant human endostatin (Endostar)DRUG

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.

Also known as: Durvalumab
Endostar combined Radiation
Thoracic irradiation of 50 Gy with 3DCRT or IMRTRADIATION

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.

Endostar combined Radiation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Endostatinsendostar proteindurvalumabRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Angiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological FactorsRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief Physician

Study Record Dates

First Submitted

August 18, 2020

First Posted

November 3, 2020

Study Start

December 1, 2020

Primary Completion

February 1, 2022

Study Completion

August 1, 2023

Last Updated

November 3, 2020

Record last verified: 2020-10