Clinical trial NCT04984148: Construction of CT Radiomics Model for Predicting the Efficacy of Immunotherapy in Patients With Stage III NSCLC
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stage III Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer
radiomics
immunotherapy
chemoradiotherapy
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen University
First posted: 2021-07-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with stage III NSCLC undergo radical intervention.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The association of CT radiomics features with PD-L1 expression of the tumor
timeFrame: 12 weeks
Secondary outcomes:
measure: Association between CT radiomics model and progression-free survival of chemoradiotherapy followed by ICI
timeFrame: 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
measure: Association between CT radiomics model and overall survival of chemoradiotherapy followed by ICI
timeFrame: From date of inclusion to the trial until the date of death from any cause, assessed up to 5 years
measure: Association between CT radiomics model and ICI related pneumonitis
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References: