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

5. května 2026 aktualizováno: Ho Yun Lee, Samsung Medical Center

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

This is a prospective observational study designed to evaluate imaging biomarkers in patients with resectable non-small cell lung cancer who receive neoadjuvant chemoimmunotherapy before planned surgery.

Neoadjuvant chemoimmunotherapy has become an important treatment option for resectable non-small cell lung cancer. Although pathologic complete response and major pathologic response are associated with favorable outcomes, reliable noninvasive methods for predicting these responses remain limited. Imaging biomarkers derived from computed tomography may provide a quantitative and repeatable way to assess tumor burden, nodal disease, treatment response, and treatment-related lung toxicity over time.

In this study, participants will undergo chest computed tomography before starting neoadjuvant chemoimmunotherapy and again after completion of neoadjuvant treatment before surgery. If disease progression is clinically suspected before planned surgery, an additional computed tomography scan may be performed and used for response assessment. Computed tomography scans will be acquired using a standardized imaging protocol. In addition to conventional computed tomography reconstruction, high-resolution deep learning-based computed tomography reconstruction will be applied after image acquisition.

The study will evaluate imaging features of the primary tumor, lymph nodes, suspected extranodal extension, adjacent structure involvement, radiologic treatment response, and possible immune-related pneumonitis. Imaging findings will be compared with clinical data, molecular and immunohistochemical findings, and surgical pathology findings, including pathologic complete response, major pathologic response, final pathologic stage, extranodal extension, and spread through air spaces when available.

The study will also explore whether imaging biomarkers are associated with progression-free survival, overall survival, treatment-related pneumonitis, and whether high-resolution deep learning-based CT reconstruction improves imaging biomarker development compared with conventional reconstruction. The anticipated enrollment is 150 participants.

Typ studie

Pozorovací

Zápis (Odhadovaný)

150

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Predictive performance of computed tomography-based imaging biomarkers for pathologic complete response
Časové okno: From baseline computed tomography before neoadjuvant chemoimmunotherapy to surgical pathology assessment after surgery, up to 6 months after enrollment.
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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Association between computed tomography-based imaging biomarkers and progression-free survival
Časové okno: From initiation of neoadjuvant chemoimmunotherapy through disease progression, recurrence, death, or last follow-up, up to study completion.
The association between computed tomography-based imaging biomarkers and progression-free survival will be evaluated. Progression-free survival is defined as the time from initiation of neoadjuvant chemoimmunotherapy to disease progression, recurrence, or death, whichever occurs first.
From initiation of neoadjuvant chemoimmunotherapy through disease progression, recurrence, death, or last follow-up, up to study completion.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Samsung Medical Center

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. února 2026

Primární dokončení (Odhadovaný)

1. prosince 2028

Dokončení studie (Odhadovaný)

1. prosince 2028

Termíny zápisu do studia

První předloženo

23. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

23. dubna 2026

První zveřejněno (Aktuální)

30. dubna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 2024-12-118

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared. This study includes clinical data, imaging-derived data, molecular and pathologic information, and follow-up outcome data from patients with resectable non-small cell lung cancer. Because of the potential risk of participant re-identification and the absence of a pre-specified external IPD sharing plan in the study protocol and informed consent process, individual participant-level data will not be made available to other researchers.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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