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NCT Number: NCT07668037

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

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.

Recruiting

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Key information

Conditions

Non-Small Cell Carcinoma of Lung Advanced Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Immunotherapy Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. OS

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Wang, MD,PhD

CONTACT

[email protected]

8610-87788029

Jie Zhao, MD

CONTACT

[email protected]

17801204737

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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