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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| OS | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Wang, MD,PhD | Contact | 8610-87788029 | zlhuxi@163.com | |
| Jie Zhao, MD | Contact | 17801204737 | zhaojie_12@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Wang, MD, PhD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
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Eligible tumor tissue specimens (formalin-fixed paraffin-embedded [FFPE] blocks and frozen tissues) and peripheral blood samples (plasma, peripheral blood mononuclear cells [PBMCs], and serum) will be retained from enrolled patients.
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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