Characterization of Multi-Omics Landscapes and AI Pathological Prediction Model for Long-Term Survival in NSCLC Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Carcinoma of Lung, Immunotherapy, Advanced Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Primary outcome measures
- 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).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07668037 · NCC6168