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

5. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Sydkorea
      • Seoul, Sydkorea
        • Rekruttering
        • Samsung Medical Center
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Predictive performance of computed tomography-based imaging biomarkers for pathologic complete response
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Association between computed tomography-based imaging biomarkers and progression-free survival
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samsung Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2024-12-118

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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