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

NCT07668037 | Recruiting

• 1 other identifier: NCC6168
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jie Wang, MD, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Wang, MD,PhD

CONTACT

8610-87788029; zlhuxi@163.com

Jie Zhao, MD

CONTACT

17801204737; zhaojie_12@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Medical Oncology

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 25, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)