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Characterization of Multi-Omics Landscapes and AI Pathological Prediction Model for Long-Term Survival in NSCLC Immunotherapy

22. juni 2026 oppdatert av: Jie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Characterization of Multi-Omics Landscapes in Long-Term Survival Following Immunotherapy and Development of an AI Pathological Prediction Model for Long-Term Survival Based on H&E-Stained Images in Advanced Non-Small Cell Lung Cancer

This study is a retrospective, multicenter, observational cohort study in patients with advanced or locally advanced non-small cell lung cancer (NSCLC). The aim of this study was to establish a long-term survival (LTS) versus short-term survival (STS) real-world cohort, to systematically characterize the multi-omics landscapes, and to develop and validate an artificial intelligence (AI) pathological prediction model based on routine H&E-stained images for predicting immune microenvironment features and long-term survival outcomes following immunotherapy.

Studieoversikt

Status

Rekruttering

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

600

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Jie Wang, MD,PhD
Telefonnummer: 8610-87788029
E-post: zlhuxi@163.com

Studer Kontakt Backup

Navn: Jie Zhao, MD
Telefonnummer: 17801204737
E-post: zhaojie_12@163.com

Studiesteder

Kina
- - Beijing, Kina
    - Rekruttering
    - Cancer Hospital Chinese Academy of Medical Sciences
    - Ta kontakt med:
      
      Jie Zhao, MD
      
      Telefonnummer: 17801204737
      
      E-post: zhaojie_12@163.com
    - Ta kontakt med:
      
      Jie Wang, MD, PhD
      
      Telefonnummer: 8610-87788029
      
      E-post: zlhuxi@163.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

This study population consists of patients with pathologically confirmed advanced or locally advanced non-small cell lung cancer (NSCLC) who received immune checkpoint inhibitor (ICI)-based therapy (monotherapy or combination therapy) as first-line or later-line treatment. Participants are derived from real-world data across multiple centers in China, including Cancer Hospital, Chinese Academy of Medical Sciences, and its affiliated hospitals, as well as from completed phase III clinical trials (Choice-01, Rationale-307, Rationale-304). A total of approximately 600 patients will be included and classified into two groups based on overall survival: long-term survival group (LTS, OS > 5 years) and short-term survival group (STS, OS < 1 year).

Beskrivelse

Inclusion Criteria:

Patients with pathologically confirmed advanced or locally advanced non-small cell lung cancer (NSCLC).
Patients derived from real-world data of multiple centers (including Cancer Hospital, Chinese Academy of Medical Sciences; Cancer Hospital of Shanxi, Chinese Academy of Medical Sciences [Shanxi Cancer Hospital]; and other participating centers) or from completed phase III clinical trials (e.g., Choice-01, Rationale-307, Rationale-304).
Patients who received first-line or later-line immune checkpoint inhibitor (ICI) monotherapy or ICI-based combination therapy.
Patients with complete clinical information and available follow-up data.

Exclusion Criteria:

Patients whose systemic therapy did not include an immunotherapy regimen.
Patients lost to follow-up.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Long-term survival (LTS) group patients with overall survival of more than 5 years after initial immunotherapy
Short-term survival (STS) group patients with overall survival of less than 1 year after initial immunotherapy

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
OS Tidsramme: From date of first ICI-based therapy initiation to death due to any cause, or censored at the date of last known follow-up, assessed up to 5 years (retrospectively collected from medical records).	Overall Survival	From date of first ICI-based therapy initiation to death due to any cause, or censored at the date of last known follow-up, assessed up to 5 years (retrospectively collected from medical records).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Etterforskere

Hovedetterforsker: Jie Wang, MD, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2026

Primær fullføring (Antatt)

1. mai 2030

Studiet fullført (Antatt)

1. mai 2030

Datoer for studieregistrering

Først innsendt

17. juni 2026

Først innsendt som oppfylte QC-kriteriene

22. juni 2026

Først lagt ut (Faktiske)

25. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)