Actively Recruiting

Age: 18Years +
All Genders
ID07559123

Imaging-based Prediction of Eligibility for ChemoImmunotherapy in Resectable NSCLC, iPRECISE

Led by Samsung Medical Center · Updated on 2026-05-08

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating imaging features from chest computed tomography (CT) scans to better predict how adults with resectable non-small cell lung cancer (NSCLC) respond to neoadjuvant chemoimmunotherapy given before surgery. This observational study aims to find CT scan characteristics that correlate with how well the cancer responds pathologically and to assess links with treatment side effects and long-term outcomes like disease progression and survival. The study also explores whether advanced deep learning-based CT reconstruction improves imaging biomarker development. Participants will receive standard clinical care involving neoadjuvant chemoimmunotherapy followed by surgery. Chest CT scans are obtained before starting chemoimmunotherapy and again after completing it, just before surgery. Additional CT scans may be done if disease progression is suspected. The study applies both conventional and high-resolution deep learning-based CT reconstruction to the images to evaluate tumor features, lymph node involvement, and possible immune-related lung inflammation. During the study, participants undergo standardized CT imaging and clinical monitoring. Researchers will compare imaging findings with clinical data, molecular markers, and surgical pathology results including pathologic complete and major responses. Outcomes like progression-free and overall survival will also be evaluated. The study involves follow-up through surgery and up to six months for primary outcome assessment, with longer-term monitoring for disease progression and survival. This may help develop noninvasive methods to guide treatment planning for NSCLC patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Resectable NSCLC of stage IIIA or lower
  • Planned to receive neoadjuvant chemoimmunotherapy before surgery according to standard clinical practice
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Able and willing to provide written informed consent after detailed study explanation
Not Eligible

You will not qualify if you...

  • No measurable lesion (less than 10 mm on spiral/multidetector computed tomography)
  • History of another malignancy within 5 years before enrollment (except treated basal cell skin carcinoma or cervical carcinoma in situ)
  • History of uncontrolled seizures, central nervous system disease, or psychiatric disorder interfering with participation or consent
  • History of severe allergic reaction to iodinated CT contrast media
  • Acute renal failure or moderate to severe renal impairment (creatinine clearance below 45 mL/min/1.73 m² or serum creatinine above 1.5 times upper normal limit)
  • Major surgery within 4 weeks before enrollment or incomplete recovery from major surgery
  • Currently pregnant or breastfeeding; women of childbearing potential without a negative baseline pregnancy test
  • Men or women of childbearing potential unwilling to use appropriate contraception during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 6 months from baseline to surgery

Participants undergo chest computed tomography scans before starting neoadjuvant chemoimmunotherapy and again after completing neoadjuvant treatment before surgery. Additional scans may be performed if disease progression is suspected.

2 to 3 visits (in-person) depending on disease progression

Surgery and Immediate Post-operative Care

Duration - Up to several weeks around surgery

Participants receive planned surgery following neoadjuvant chemoimmunotherapy, with immediate post-operative care.

1 surgical visit and immediate post-operative care visits

Long-term Monitoring

Duration - Up to study completion (several years)

Participants are monitored for progression-free survival, overall survival, and treatment-related effects following surgery and neoadjuvant chemoimmunotherapy.

Periodic follow-up visits as per clinical practice

Trial Site Locations

Total: 1 location

1

Samsung Medical Center

Seoul, South Korea

Actively Recruiting

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Research Team

H

Ho Yun Lee, Prof.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Deep learning for predicting major pathological response to neoadjuvant chemoimmunotherapy in non-small cell lung cancer: A multicentre study.

Yunlang She, Bingxi He, Fang Wang...

https://pubmed.ncbi.nlm.nih.gov/36395737

Improved Event-Free Survival After Complete or Major Pathologic Response in Patients With Resectable NSCLC Treated With Neoadjuvant Chemoimmunotherapy Regardless of Adjuvant Treatment: A Systematic Review and Individual Patient Data Meta-Analysis.

Daniele Marinelli, Antonio Nuccio, Alessandro Di Federico...

https://pubmed.ncbi.nlm.nih.gov/39389220