NCT05260606

Imaging Biomarkers for Immune Checkpoint Inhibitor Treatment in Patients With Non-small Cell Lung Cancer

Imaging Biomarkers for Immune Checkpoint Inhibitor Treatment in Patients With Non-small Cell Lung Cancer: Prospective Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1. Hypothesis : imaging biomarkers of tumor measured by F-18 fluorodeoxyglucose (FDG) positron emission tomography(PET)/computed tomography(CT) is correlated with immune checkpoint inhibitor (ICI) treatment response and patient prognosis. 2. Purpose: To evaluate the association between metabolic imaging parameters measured by F-18 FDG PET/CT and clinical outcomes in patients with non-small cell lung cancer treated with ICIs. 3. Study subject: patients with non-small cell lung cancer who will be treated with ICIs. 4. Study design: prospective observational study 5. Intervention: F-18 FDG PET/CT

Detailed description

1\. Study purposes 1. Primary purpose: To evaluate the association between metabolic imaging parameters measured by F-18 FDG PET/CT and treatment response in non-small cell lung cancer (NSCLC) patients treated with ICIs. 2. Secondary purpose: To evaluate the association between PET imaging parameters, patient prognosis, CT imaging parameters, and other biomarkers, and to compare treatment response evaluation criteria. 2\. Background: development of ICIs opened a new paradigm for cancer treatment. It enables long-term survival of patients with advanced cancers, which could not be expected to be effective with conventional chemotherapy. Therapeutic response and prognosis to ICIs have unique characteristics which are different from those of conventional cytotoxic or targeted therapies. Even if the initial response rate is not high, if the treatment effect is effective, the effect is long-lasting and enabling long-term survival. With the evaluation criteria based on the change in tumor size, it is difficult to differentiate between an atypical response of ICIs and disease progression. Therefore, a new type of approach is required. F-18 FDG PET/CT is an imaging method that is currently used for many cancers. In recent studies on the response evaluation of ICIs using FDG PET/CT, FDG PET/CT has shown potential as a predictive tool of therapeutic response and prognosis. However, despite the potential, most of the related studies are retrospective design and small in scale. Additionally, it is not known which PET imaging features are suitable for predicting treatment response and prognosis. A novel image analysis method based on image informatics has been tried. After extracting image features from imaging modalities such as PET, CT, MRI, they are fused with clinical information and genetic information and analyzed through an artificial intelligence-based platform. It has been reported that a predictive model based on CT image features can predict the treatment response to ICI. However, the efficacy of imaging biomarkers for predicting ICI treatment response has not yet been proven, and further prospective studies are needed. Therefore, patients with NSCLC to be treated with ICI will receive FDG PET/CT before and during treatment in this study. In addition, PET images will be comprehensively analyzed together with other image data, biomarkers, and clinical data, and will be used as basic data for future ICI prediction models. 3\. Study design: single institution, single-arm, prospective observational study 4\. Study population: NSCLC patients who are scheduled to receive ICI in our institution 5\. Recruitment: clinical referrals 6\. Target number: 100 patients available for analysis. 7\. Intervention: F-18 FDG PET/CT scan 7\. Study protocol 1. Study participants will have FDG PET/CT before and during ICI Tx. 2. There is no difference from the treatment schedule performed in usual clinical setting except for an additional F-18 FDG PET/CT scan. Detailed plan of ICI treatment and patient management (dose, administration date, treatment period, and follow-up) follows the standard protocol of our institution in this study. 3. Scans: 1st scan (pre-treatment), 2nd scan (interim), 3rd scan (Optional) 8\. Variables 1. Death status, date of death 2. Disease progression status, date of disease progression 3. ICI type and dose 4. First day of ICI treatment, end day of ICI treatment, ICI treatment cycle 5. Hospital visit dates 6. Neutrophil to lymphocyte ratio (NLR) 7. Immunochemical staining results \[PD-L1: Combined positive score (CPS) and tumor proportion score (TPS)\] 8. Other blood and biopsy results 9. FDG PET/CT imaging parameters \[Standard uptake value (SUV)max, SUVpeak, metabolic tumor volume (MTV), total lesion glycolysis (TLG), spleen to liver ratio (SLR), etc\] 10. CT imaging parameters 11. PET-based treatment response: positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) criteria/ immune PERCIST (iPERCIST)/ Deauville score 12. CT-based treatment response: response Criteria in Solid Tumors (RECIST v1.1) criteria / immune RECIST (iRECIST) criteria / immune-modified RECIST (imRECIST)

Conditions

• Carcinoma, Non-Small-Cell Lung
• Immune Checkpoint Inhibitors

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	F-18 FDG PET/CT	1. 1st scan: pre-Tx, ICI Tx must be started within 35 days after 1st scan. 2. 2nd scan: interim * Pembrolizumab or atezolizumab: after the 2nd Tx cycle to before the start of the 3rd Tx cycle * Nivolumab: after the 3rd Tx cycle to before the start of the 4th Tx cycle 3. 3rd scan: optional (3rd scan can be performed when disease progression is suspected) 4. Imaging * Fasting: at least 6 hours * Blood glucose level: \< 200 mg/dL * F-18 FDG 0.14 mCi/kg (IV) * Image acquisition: 1 hr after FDG injection, CT images are acquired. After CT scan, PET images are acquired and attenuation-corrected PET images are reconstructed based on the CT image data. * PET/CT: Discovery MIDR or MI (GE Healthcare, Chicago, Illinois, USA) * First and second scans have to be performed with same scan.

Timeline

• Start date: 2022-05-09
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-03-02
• Last updated: 2024-04-17

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study