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

Recruiting now

Conditions studied: NSCLC, Neoadjuvant Chemoimmunotherapy, CT

In brief

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.

Key facts

Study ID: NCT07559123
Run by: Samsung Medical Center
People needed: 150
Starts: 2026-02-01
Expected to finish: 2028-12-01
Last updated by the study team: 2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age: 18 years or older.
Diagnosis: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
Staging: Resectable NSCLC of stage IIIA or lower.
Treatment Plan: Planned to receive neoadjuvant chemoimmunotherapy before surgery according to standard clinical practice.
Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Informed Consent: Able and willing to provide written informed consent after receiving a detailed explanation of the study.

You may not qualify if…

No Measurable Lesion: Participants must have at least one measurable lesion (>= 10 mm on spiral/multidetector computed tomography).
Prior Malignancy: History of another malignancy within 5 years before enrollment (excluding adequately treated basal cell skin carcinoma or cervical carcinoma in situ).
Neurological/Psychiatric Conditions: History of clinically significant uncontrolled seizures, CNS disease, or psychiatric disorders that may interfere with study participation or consent.
Contrast Allergy: History of severe allergic reaction to iodinated CT contrast media.
Renal Impairment: Acute renal failure or moderate to severe renal impairment (CrCl < 45 mL/min/1.73 m² or serum creatinine > 1.5x upper limit of normal).
Recent Surgery: Major surgery within 4 weeks of enrollment or incomplete recovery from major surgery.
Pregnancy/Nursing: Currently pregnant or breastfeeding; women of childbearing potential without a negative baseline pregnancy test.
Contraception: Men or women of childbearing potential unwilling to use appropriate contraception during the study.

Where it is running

Samsung Medical Center — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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