Using CT scans to predict benefit from chemoimmunotherapy before lung cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study of adults with resectable (≤ stage IIIA) non-small cell lung cancer who will receive standard-of-care neoadjuvant chemoimmunotherapy prior to planned surgery. Participants undergo chest CT using a standardized protocol before starting treatment and again after completing neoadjuvant therapy (with additional scans if progression is suspected), and images will be processed with conventional and high-resolution deep learning–based reconstructions. Investigators will extract imaging features of the primary tumor, lymph nodes, suspected extranodal extension, adjacent structure involvement, radiologic response, and treatment-related lung changes and compare them with surgical pathology outcomes such as pathologic complete response and major pathologic response. The aim is to identify reproducible CT-derived biomarkers that correlate with response and toxicity without altering clinical care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Ho Yun Lee, Prof.
• Email: hoyunlee96@gmail.com
• Phone: 82-02-3410-2502

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.