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

Stage III Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04984148
• Other study ID #: GDREC2019152H
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2021
• Source: Guangdong Provincial People's Hospital
• Contact: Yi Pan
• Phone: +862083827812
• Email: panyiff011[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 31, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Previous thoracic radiotherapy

• Palliative treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage III Non-small Cell Lung Cancer

Intervention

Diagnostic Test:
• CT
Contrast-enhanced thoracic computed tomography

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital	Shenzhen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Association between CT radiomics model and progression-free survival of chemoradiotherapy followed by ICI	To construct CT radiomics model for evaluating progression-free survival in patients undergo 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
Secondary	Association between CT radiomics model and overall survival of chemoradiotherapy followed by ICI	to assess the association between CT radiomics features and overall survival	From date of inclusion to the trial until the date of death from any cause, assessed up to 5 years
Secondary	Association between CT radiomics model and ICI related pneumonitis	To develop CT radiomics signatures for predicting ICI related pneumonitis	5 years