Stage III Non-small Cell Lung CancerNCT04984148
Construction of CT Radiomics Model for Predicting the Efficacy of Immunotherapy in Patients With Stage III NSCLC
An observational study of Stage III Non-small Cell Lung Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Non-small Cell Lung Cancer
- What is being tested?
- CT
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with stage III NSCLC undergo radical intervention.
Who may be able to join
- 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
Who cannot join
- Previous thoracic radiotherapy
- Palliative treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Yi Pan, Dr., +86-020-83827812, panyiff01@163.com
About this study
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
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.
Read the 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.
- Conditions
- Stage III Non-small Cell Lung Cancer
- Being tested
- CT
- Keywords
- non-small cell lung cancer, radiomics, immunotherapy, chemoradiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTDiagnostic test
Also called Radiomics
Contrast-enhanced thoracic computed tomography
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (3)
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
Measured: 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
to assess the association between CT radiomics features and overall survival
Measured: 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
To develop CT radiomics signatures for predicting ICI related pneumonitis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Feb 2019
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen University
- Responsible party
- Principal investigator, YI PAN, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984148
- Sponsor's protocol ID
- GDREC2019152H
- Status last verified
- Nov 2021
- First submitted
- 25 Jul 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04984148
- Acronym / sponsor ID
- GDREC2019152H
- Conditions
- Stage III Non-small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, radiomics, immunotherapy, chemoradiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Shenzhen University
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial cohort：Chemoradiotherapy followed by immunotherapy | – | Diagnostic Test: CTContrast-enhanced thoracic CT: before, during and after radiotherapy Radiomics PD-L1 testing (Histological analysis of biopsy) Molecular Markers (Histological analysis of biopsy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with stage III NSCLC undergo radical intervention.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Previous thoracic radiotherapy
- Palliative treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTAlso: RadiomicsContrast-enhanced thoracic computed tomography | Diagnostic test | Trial cohort：Chemoradiotherapy followed by immunotherapy |
Primary outcome
The association of CT radiomics features with PD-L1 expression of the tumor
Time frame: 12 weeks
To construct a radiomics model for predicting PD-L1 expression after chemoradiotherapy
3 secondary outcomes
Association between CT radiomics model and progression-free survival of chemoradiotherapy followed by ICI
Time frame: 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
Time frame: 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
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage III Non-small Cell Lung Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Pan (+862083827812, panyiff011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association of CT radiomics features with PD-L1 expression of the tumor (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.