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

Sponsor

Guangdong Provincial People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04984148

Collaborator

Shenzhen University (Other)

Enrollment

Location

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stage III Non-small Cell Lung Cancer	Diagnostic Test: CT

Detailed Description

This is an observational longitudinal prospective study.

CT scan is performed before radiotherapy, during radiotherapy and at the end of radiotherapy in patients with unresectable locally advanced NSCLC who undergo CRT. Radiomic features were extracted from CT images and baseline PD-L1 expression is assessed. CT-based radiomics models is developed to assess PD-L1 expression and predict the efficacy of ICI.

Study Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Construction of CT Radiomics Model to Assess PD-L1 Status and Predict the Efficacy of Chemoradiotherapy Combined With Immunotherapy in Unresectable Locally Advanced Non-small Cell Lung Cancer

Actual Study Start Date :

Feb 1, 2019

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 Contrast-enhanced thoracic computed tomography Other Names: Radiomics

Arm

Intervention/Treatment

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

Contrast-enhanced thoracic computed tomography

Other Names:

Radiomics

Outcome Measures

Primary Outcome Measures

The association of CT radiomics features with PD-L1 expression of the tumor [12 weeks]
To construct a radiomics model for predicting PD-L1 expression after chemoradiotherapy

Secondary Outcome Measures

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]
To construct CT radiomics model for evaluating progression-free survival in patients undergo chemoradiotherapy followed by ICI
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]
to assess the association between CT radiomics features and overall survival
Association between CT radiomics model and ICI related pneumonitis [5 years]
To develop CT radiomics signatures for predicting ICI related pneumonitis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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