Skip to content

Prediction of Targeted Therapy Efficacy in EGFR-mutant Lung Cancer Patients Using AI-based Multimodal Data

A Retrospective Analysis Study on Predicting the Efficacy of Targeted Therapy in Lung Cancer Patients With EGFR Mutations Based on AI-driven Multimodal Data

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07287904
Enrollment
1000
Registered
2025-12-17
Start date
2025-12-25
Completion date
2027-08-31
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma Lung, EGFR Activating Mutation, Lung Cancer (NSCLC), Postoperative Adjuvant Therapy

Brief summary

The main purpose of this study is to explore the value of multimodal imaging information and models in predicting the prognosis of EGFR-positive non-small cell lung cancer patients undergoing targeted therapy, providing a basis for selecting suitable populations for precise tumor treatment and corresponding therapy. We retrospectively analyzed patient case data, extracted preoperative CT images, H&E-stained whole-slide digital pathology images, and pre- or postoperative genetic testing reports to extract radiomic features of tumor and peritumoral regions. These features were combined with multidimensional pathological features and gene expression distribution characteristics to construct a multimodal radiopathogenomic model, offering more precise prognostic evaluation for lung cancer patients receiving targeted therapy.

Detailed description

This study is an observational study, aiming to retrospectively include data from 500 patients diagnosed with stage IB-IIIA invasive lung adenocarcinoma who underwent radical surgery at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, from January 2021 to December 2024, along with data from a total of 1,000 patients from other multi-center sites. The study will collect and record information on subjects' demographics, pathology, imaging, genetic testing, and clinical characteristics via the hospital's electronic medical record system. Patient survival status will be obtained through telephone follow-ups and home visits. Radiomic features of the tumor and peritumoral regions will be extracted from preoperative CT images, H&E-stained digital whole-slide pathology images, and genetic testing reports. These will be combined with multi-dimensional pathological features and gene expression distribution characteristics from the patient cases to construct a multi-omics model integrating imaging, pathology, demographics, and genetics, providing a more precise prognostic assessment for targeted therapy in lung cancer patients.

Interventions

DIAGNOSTIC_TESTComprehensive analysis through laboratory tests, imaging techniques, and clinical data

Extract radiomics features of the tumor and peritumoral regions from preoperative CT images, H&E-stained digital pathology whole-slide images, and genetic test reports, and integrate them with multidimensional pathological features and gene expression distribution characteristics to construct a radiopathogenomic multi-omics modality, providing more precise prognostic assessment for targeted therapy in lung cancer patients.

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18-80 years, undergoing radical surgery for lung cancer (R0 resection); 2. Postoperative pathological stage IB-IIIA, pathology confirmed as adenocarcinoma; 3. EGFR gene testing positive, EGFR 19del/L858R mutation; 4. Receiving postoperative EGFR-TKI targeted adjuvant therapy; 5. Complete and clear preoperative imaging data, genetic testing report, and pathology report available.

Exclusion criteria

1. Patients negative for EGFR; 2. Incomplete surgical resection (R1, R2); 3. Did not receive EGFR-TKI targeted therapy after surgery; 4. Recurrent or advanced stage patients; 5. Incomplete preoperative or postoperative data; 6. Patients who died within 30 days post-surgery.

Design outcomes

Primary

MeasureTime frameDescription
DFStwo yearsThe endpoint of this study was disease-free survival (DFS), defined as the time interval from surgery to the first recurrence or death,assessed up to 24 months。

Countries

China

Contacts

Primary ContactNa Li, Dr
ln19931020@126.com02785726114
Backup ContactXiaorong Dong, Dr
xiaorongdong@hust.edu.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026