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

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

Status: Not yet enrolling

Conditions: Postoperative Adjuvant Therapy; EGFR Activating Mutation; Adenocarcinoma Lung; Lung Cancer (NSCLC)

Treatments: Diagnostic Test: Comprehensive analysis through laboratory tests, imaging techniques, and clinical data

Study type: Observational

Funder types: Other

Identifiers

NCT07287904

AIEF20250825

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.