Clinical Trial

Imaging-based PRediction of Eligibility for ChemoImmunotherapy in reSEctable NSCLC, iPRECISE

Study acronym: iPRECISE
Recruiting
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Summary
This study is for adults with resectable non-small cell lung cancer who are scheduled to receive neoadjuvant chemoimmunotherapy before surgery. Neoadjuvant chemoimmunotherapy can help shrink lung cancer before surgery and may improve treatment outcomes. However, not all patients benefit from this treatment in the same way, and it can sometimes cause side effects, such as immune-related pneumonitis. At present, it is still difficult to predict before or during treatment which patients will have a strong response. The purpose of this study is to find imaging features on chest computed tomography scans that may help predict how well a patient's cancer responds to neoadjuvant chemoimmunotherapy. The study will compare computed tomography findings before treatment and before surgery with pathologic findings from surgery, including pathologic complete response and major pathologic response. The study will also evaluate whether computed tomography-based imaging features are associated with treatment-related side effects and long-term outcomes such as disease progression and survival. This is an observational study. The investigators will not assign participants to a specific cancer treatment. Participants will receive neoadjuvant chemoimmunotherapy and surgery according to standard clinical practice. Chest computed tomography scans will be obtained before treatment and before surgery as part of the study protocol. These computed tomography images will also be reconstructed using a high-resolution deep learning-based computed tomography reconstruction technique to explore whether this approach can improve the development of imaging biomarkers. The results of this study may help develop a noninvasive imaging-based model to identify patients who are more likely to benefit from neoadjuvant chemoimmunotherapy and to better guide treatment planning for resectable non-small cell lung cancer.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-05-06
Trial Details
NCT Number NCT07559123
Lead Sponsor Samsung Medical Center
Conditions NSCLC, Neoadjuvant Chemoimmunotherapy, CT
Enrollment 150 participants
Start Date 2026-02-01
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-08