Lung Cancer (NSCLC)NCT07287904
Prediction of Targeted Therapy Efficacy in EGFR-mutant Lung Cancer Patients Using AI-based Multimodal Data
An observational study of Lung Cancer (NSCLC) and EGFR Activating Mutation, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer (NSCLC), EGFR Activating Mutation, Adenocarcinoma Lung
- What is being tested?
- Comprehensive analysis through laboratory tests, imaging techniques, and clinical data
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospectively included data from 1000 patients diagnosed with stage IB-IIIA invasive lung adenocarcinoma with EGFR mutations who underwent radical surgery from January 2021 to December 2024.
Who may be able to join
- Age 18-80 years, undergoing radical surgery for lung cancer (R0 resection);
- Postoperative pathological stage IB-IIIA, pathology confirmed as adenocarcinoma;
- EGFR gene testing positive, EGFR 19del/L858R mutation;
- Receiving postoperative EGFR-TKI targeted adjuvant therapy;
- Complete and clear preoperative imaging data, genetic testing report, and pathology report available.
Who cannot join
- Patients negative for EGFR;
- Incomplete surgical resection (R1, R2);
- Did not receive EGFR-TKI targeted therapy after surgery;
- Recurrent or advanced stage patients;
- Incomplete preoperative or postoperative data;
- Patients who died within 30 days post-surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaorong Dong, Dr contact
China1 site
Wuhan Union Hospital
Wuhan, Hubei, 430022
Na Li, Dr, 02785726114, ln19931020@126.com
About this study
Official title: A Retrospective Analysis Study on Predicting the Efficacy of Targeted Therapy in Lung Cancer Patients With EGFR Mutations Based on AI-driven Multimodal Data
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.
Read the 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.
- Conditions
- Lung Cancer (NSCLC), EGFR Activating Mutation, Adenocarcinoma Lung, Postoperative Adjuvant Therapy
- Being tested
- Comprehensive analysis through laboratory tests, imaging techniques, and clinical data
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive analysis through laboratory tests, imaging techniques, and clinical dataDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
The 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。
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start25 Dec 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaorong Dong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Xiaorong Dong, Dr, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287904
- Sponsor's protocol ID
- AIEF20250825
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vaidya P, Bera K, Gupta A, Wang X, Corredor G, Fu P, Beig N, Prasanna P, Patil PD, Velu PD, Rajiah P, Gilkeson R, Feldman MD, Choi H, Velcheti V, Madabhushi A. CT derived radiomic score for predicting the added benefit of adjuvant chemotherapy following surgery in stage I, II resectable non-small cell lung cancer: a retrospective multicohort study for outcome prediction. Lancet Digit Health. 2020 Mar;2(3):e116-e128. doi: 10.1016/S2589-7500(20)30002-9. Epub 2020 Feb 13.
PubMed 33334576Chen M, Lu H, Copley SJ, Han Y, Logan A, Viola P, Cortellini A, Pinato DJ, Power D, Aboagye EO. A Novel Radiogenomics Biomarker for Predicting Treatment Response and Pneumotoxicity From Programmed Cell Death Protein or Ligand-1 Inhibition Immunotherapy in NSCLC. J Thorac Oncol. 2023 Jun;18(6):718-730. doi: 10.1016/j.jtho.2023.01.089. Epub 2023 Feb 10.
PubMed 36773776Lin H, Hua J, Gong Z, Chen M, Qiu B, Wu Y, He W, Wang Y, Feng Z, Liang Y, Long W, Li R, Kuang Q, Chen Y, Lu J, Luo S, Zhao W, Yan L, Chen X, Shi Z, Xu Z, Mo Z, Liu E, Han C, Cui Y, Yang X, Chen X, Liu J, Pan X, Madabhushi A, Lu C, Liu Z. Multimodal radiopathological integration for prognosis and prediction of adjuvant chemotherapy benefit in resectable lung adenocarcinoma: A multicentre study. Cancer Lett. 2025 Apr 28;616:217557. doi: 10.1016/j.canlet.2025.217557. Epub 2025 Feb 13.
PubMed 39954935
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis Study on Predicting the Efficacy of Targeted Therapy in Lung Cancer Patients With EGFR Mutations Based on AI-driven Multimodal Data
- ClinicalTrials.gov ID
- NCT07287904
- Acronym / sponsor ID
- AIEF20250825
- Conditions
- Lung Cancer (NSCLC), EGFR Activating Mutation, Adenocarcinoma Lung, Postoperative Adjuvant Therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospectively included data from 1000 patients diagnosed with stage IB-IIIA invasive lung adenocarcinoma with EGFR mutations who underwent radical surgery from January 2021 to December 2024.
Key inclusion criteria (5 listed)
- Age 18-80 years, undergoing radical surgery for lung cancer (R0 resection);
- Postoperative pathological stage IB-IIIA, pathology confirmed as adenocarcinoma;
- EGFR gene testing positive, EGFR 19del/L858R mutation;
- Receiving postoperative EGFR-TKI targeted adjuvant therapy;
- Complete and clear preoperative imaging data, genetic testing report, and pathology report available.
Key exclusion criteria (6 listed)
- Patients negative for EGFR;
- Incomplete surgical resection (R1, R2);
- Did not receive EGFR-TKI targeted therapy after surgery;
- Recurrent or advanced stage patients;
- Incomplete preoperative or postoperative data;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive analysis through laboratory tests, imaging techniques, and clinical dataExtract 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. | Diagnostic test | – |
Primary outcome
DFS
Time frame: two years
The 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。
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Results publication: PubMed 33334576Vaidya P, Bera K, Gupta A, Wang X, Corredor G, Fu P, Beig N, Prasanna P, Patil PD, Velu PD, Rajiah P, Gilkeson R, Feldman MD, Choi H, Velcheti V, Madabhushi A. CT derived radiomic score for predicting the added benefit of adjuvant chemotherapy following surgery in stage I, II resectable non-small cell lung cancer: a retrospective multicohort study for outcome prediction. Lancet Digit Health. 2020 Mar;2(3):e116-e128. doi: 10.1016/S2589-7500(20)30002-9. Epub 2020 Feb 13.
- Results publication: PubMed 36773776Chen M, Lu H, Copley SJ, Han Y, Logan A, Viola P, Cortellini A, Pinato DJ, Power D, Aboagye EO. A Novel Radiogenomics Biomarker for Predicting Treatment Response and Pneumotoxicity From Programmed Cell Death Protein or Ligand-1 Inhibition Immunotherapy in NSCLC. J Thorac Oncol. 2023 Jun;18(6):718-730. doi: 10.1016/j.jtho.2023.01.089. Epub 2023 Feb 10.
- Results publication: PubMed 39954935Lin H, Hua J, Gong Z, Chen M, Qiu B, Wu Y, He W, Wang Y, Feng Z, Liang Y, Long W, Li R, Kuang Q, Chen Y, Lu J, Luo S, Zhao W, Yan L, Chen X, Shi Z, Xu Z, Mo Z, Liu E, Han C, Cui Y, Yang X, Chen X, Liu J, Pan X, Madabhushi A, Lu C, Liu Z. Multimodal radiopathological integration for prognosis and prediction of adjuvant chemotherapy benefit in resectable lung adenocarcinoma: A multicentre study. Cancer Lett. 2025 Apr 28;616:217557. doi: 10.1016/j.canlet.2025.217557. Epub 2025 Feb 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaorong Dong, Dr contact
Xiaorong Dong, Dr principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (NSCLC) and EGFR Activating Mutation, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Na Li, Dr (02785726114, ln19931020@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07287904, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.