Using CT scans to predict benefit from chemoimmunotherapy before lung cancer surgery
Imaging-based PRediction of Eligibility for ChemoImmunotherapy in reSEctable NSCLC, iPRECISE
This project will test whether CT scan features can predict how adults with resectable non-small cell lung cancer respond to chemoimmunotherapy given before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07559123 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with histologically confirmed resectable NSCLC (stage IIIA or lower), ECOG 0–1, at least one measurable lesion ≥10 mm, a planned course of neoadjuvant chemoimmunotherapy followed by surgery, and the ability to provide informed consent.
Not a fit: Patients with unresectable disease, poor performance status, no measurable lesion, a recent other malignancy, contraindications to CT imaging, or those not receiving neoadjuvant chemoimmunotherapy are unlikely to benefit from this imaging-focused protocol.
Why it matters
Potential benefit: If successful, CT-based biomarkers could help doctors identify which patients are likely to have a strong tumor response to pre-surgery chemoimmunotherapy, enabling more personalized treatment and potentially avoiding ineffective or harmful therapy.
How similar studies have performed: Previous radiomics and imaging-biomarker studies in NSCLC have shown promising but inconsistent ability to predict treatment response, so this approach is partly supported but not yet proven for neoadjuvant chemoimmunotherapy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Ho Yun Lee, Prof.
- Email: hoyunlee96@gmail.com
- Phone: 82-02-3410-2502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.