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

ConditionsNon-Small Cell Carcinoma of Lung Immunotherapy Advanced Non-Small Cell Lung Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients whose systemic therapy did not include an immunotherapy regimen.

Patients lost to follow-up.

Trial population

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).

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants

are grouped into 2 trial groups

Group A: Long-term survival (LTS) group

Group B: Short-term survival (STS) group

Trial outcomes

Primary outcomes

Overall Survival

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).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

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