Construction of CT Radiomics Model for Predicting the Efficacy of Immunotherapy in Patients With Stage III NSCLC

NCT04984148 | Unknown

• 1 other identifier: GDREC2019152H
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Consolidation immunotherapy of immune checkpoint inhibitor (ICI) following chemoradiotherapy (CRT) is the current standard of care for patients with unresectable locally advanced non-small cell lung cancer (NSCLC) as it improves both progression-free survival and overall survival. However, a substantial proportion of patients still experience disease recurrence despite consolidation ICI. It is important for personalized treatment to predict the efficacy of consolidation ICI. PD-L1 expression is used as a predictive biomarker for ICI response and efficacy in advanced NSCLC, but its role in patients with stage III disease is unclear. One important reason is PD-L1 testing performed on pre-CRT tissue may not reflect changes in PD-L1 expression after CRT. CT-based radiomics approaches have been successfully applied to generate imaging biomarkers as decision support tools for clinical practice. The hypothesis of this study is that CT radiomics model can assess PD-L1 status after CRT and predict the efficacy of CRT combined with ICI in unresectable locally advanced NSCLC.

Conditions

Stage III Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer; radiomics; immunotherapy; chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• The association of CT radiomics features with PD-L1 expression of the tumor

  To construct a radiomics model for predicting PD-L1 expression after chemoradiotherapy

  12 weeks

Secondary Outcomes (3)

• Association between CT radiomics model and progression-free survival of chemoradiotherapy followed by ICI

  From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, assessed up to 5 years

• Association between CT radiomics model and overall survival of chemoradiotherapy followed by ICI

  From date of inclusion to the trial until the date of death from any cause, assessed up to 5 years

• Association between CT radiomics model and ICI related pneumonitis

  5 years

Study Arms (1)

Trial cohort：Chemoradiotherapy followed by immunotherapy

Contrast-enhanced thoracic CT: before, during and after radiotherapy Radiomics PD-L1 testing (Histological analysis of biopsy) Molecular Markers (Histological analysis of biopsy)

Diagnostic Test: CT

Interventions

CT DIAGNOSTIC_TEST

Contrast-enhanced thoracic computed tomography

Also known as: Radiomics

Trial cohort：Chemoradiotherapy followed by immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with stage III NSCLC undergo radical intervention.

You may qualify if:

• Histological or cytological proven non-small cell lung cancer
• Unresectable stage III according to American Joint Committee of Cancer stage (the eighth edition)
• years or older

You may not qualify if:

• Previous thoracic radiotherapy
• Palliative treatment

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Shenzhen University: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiomics

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Yi Pan

CONTACT

+862083827812; panyiff011@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Radiation Oncology

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: July 30, 2021
• Study Start: February 1, 2019
• Primary Completion: September 30, 2022
• Study Completion: January 31, 2024
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

CN (1)