Imaging-based PRediction of Eligibility for ChemoImmunotherapy in reSEctable NSCLC, iPRECISE
Samsung Medical Center
150 participants
Feb 1, 2026
OBSERVATIONAL
Conditions
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 (CT) scans that may help predict how well a patient's cancer responds to neoadjuvant chemoimmunotherapy. The study will compare CT 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 CT-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 CT scans will be obtained before treatment and before surgery as part of the study protocol. These CT images will also be reconstructed using a high-resolution deep learning-based CT 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.
Eligibility
Inclusion Criteria2
- Age 18 years or older. Histologically or cytologically confirmed non-small cell lung cancer. Resectable non-small cell lung cancer of stage IIIA or lower. Planned to receive neoadjuvant chemoimmunotherapy before surgery according to standard clinical practice.
- Eastern Cooperative Oncology Group performance status of 0 or 1. Able and willing to provide written informed consent after receiving a detailed explanation of the study.
Exclusion Criteria8
- No measurable lesion. Participants must have at least one measurable lesion with a longest diameter of 10 mm or greater on spiral CT or multidetector CT, or 20 mm or greater on conventional CT.
- History of another malignancy within 5 years before enrollment, except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of clinically significant uncontrolled seizure, central nervous system disease, or psychiatric disorder that, in the investigator's judgment, may interfere with understanding the informed consent form or study participation.
- History of severe allergic reaction to iodinated CT contrast media that precludes contrast-enhanced CT.
- Acute renal failure or moderate to severe renal impairment, defined as creatinine clearance less than 45 mL/min/1.73 m² or serum creatinine greater than 1.5 times the upper limit of normal.
- Major surgery within 4 weeks before study enrollment or not fully recovered from the effects of major surgery.
- Pregnant or breastfeeding. Woman of childbearing potential who has not undergone a pregnancy test at baseline or has a positive pregnancy test result.
- Woman or man of childbearing potential who is unwilling to use appropriate contraception during the study period.
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Interventions
High-resolution deep learning-based CT reconstruction will be applied after CT image acquisition to generate additional reconstructed images. These images will be compared with conventional CT reconstruction images to evaluate their usefulness for imaging biomarker development and assessment of extranodal extension.
Locations(1)
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NCT07559123