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

NCT07559123 | Recruiting

• 1 other identifier: 2024-12-118
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

NSCLC; Neoadjuvant Chemoimmunotherapy; CT

Outcome Measures

Primary Outcomes (1)

• Predictive performance of computed tomography-based imaging biomarkers for pathologic complete response

  The predictive performance of imaging biomarkers derived from contrast-enhanced chest computed tomography scans obtained before and after neoadjuvant chemoimmunotherapy will be evaluated for pathologic complete response. Pathologic complete response will be assessed using surgical pathology findings after resection. Predictive performance will be measured using model discrimination, including the area under the receiver operating characteristic curve.

  From baseline computed tomography before neoadjuvant chemoimmunotherapy to surgical pathology assessment after surgery, up to 6 months after enrollment.

Secondary Outcomes (1)

• Association between computed tomography-based imaging biomarkers and progression-free survival

  From initiation of neoadjuvant chemoimmunotherapy through disease progression, recurrence, death, or last follow-up, up to study completion.

Interventions

High-resolution deep learning-based CT reconstruction DIAGNOSTIC_TEST

High-resolution deep learning-based computed tomography reconstruction will be applied after computed tomography image acquisition to generate additional reconstructed images. These images will be compared with conventional computed tomography reconstruction images to evaluate their usefulness for imaging biomarker development and assessment of extranodal extension.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients with resectable non-small cell lung cancer of stage IIIA or lower who are scheduled to receive neoadjuvant chemoimmunotherapy before surgery at Samsung Medical Center. Participants will be enrolled prospectively after providing written informed consent. Treatment decisions, including the use of neoadjuvant chemoimmunotherapy and surgery, will be made according to standard clinical practice and will not be assigned by the investigators. Participants will undergo chest computed tomography before neoadjuvant chemoimmunotherapy and before surgery as part of the study protocol. Imaging, clinical, molecular, and pathologic data will be collected to evaluate computed tomography-based imaging biomarkers associated with treatment response, pathologic response, treatment-related pneumonitis, and clinical outcomes.

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 ($\\ge$ 10 mm on spiral/multidetector CT or $\\ge$ 20 mm on conventional CT).
• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (5)

• She Y, He B, Wang F, Zhong Y, Wang T, Liu Z, Yang M, Yu B, Deng J, Sun X, Wu C, Hou L, Zhu Y, Yang Y, Hu H, Dong D, Chen C, Tian J. Deep learning for predicting major pathological response to neoadjuvant chemoimmunotherapy in non-small cell lung cancer: A multicentre study. EBioMedicine. 2022 Dec;86:104364. doi: 10.1016/j.ebiom.2022.104364. Epub 2022 Nov 14.

  PMID: 36395737 BACKGROUND

• Greffier J, Pastor M, Si-Mohamed S, Goutain-Majorel C, Peudon-Balas A, Bensalah MZ, Frandon J, Beregi JP, Dabli D. Comparison of two deep-learning image reconstruction algorithms on cardiac CT images: A phantom study. Diagn Interv Imaging. 2024 Mar;105(3):110-117. doi: 10.1016/j.diii.2023.10.004. Epub 2023 Nov 8.

  PMID: 37949769 BACKGROUND

• Marinelli D, Nuccio A, Di Federico A, Ambrosi F, Bertoglio P, Faccioli E, Ferrara R, Ferro A, Giusti R, Guerrera F, Mammana M, Pittaro A, Sepulcri M, Viscardi G, Gallina FT. 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. J Thorac Oncol. 2025 Mar;20(3):285-295. doi: 10.1016/j.jtho.2024.09.1443. Epub 2024 Oct 9.

  PMID: 39389220 BACKGROUND

• Sorin M, Prosty C, Ghaleb L, Nie K, Katergi K, Shahzad MH, Dube LR, Atallah A, Swaby A, Dankner M, Crump T, Walsh LA, Fiset PO, Sepesi B, Forde PM, Cascone T, Provencio M, Spicer JD. Neoadjuvant Chemoimmunotherapy for NSCLC: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 May 1;10(5):621-633. doi: 10.1001/jamaoncol.2024.0057.

  PMID: 38512301 RESULT

• Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.

  PMID: 35403841 RESULT

Central Study Contacts

Ho Yun Lee, Prof.

CONTACT

82-02-3410-2502; hoyunlee96@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)