NCT07110259Not yet recruiting
AI-Based DeepGEM Tool for Predicting Gene Mutations in NSCLC Patients: A Randomized Controlled Study
Application of the Artificial Intelligence-Based Gene Mutation Prediction Tool DeepGEM in Patients With Non-Small Cell Lung Cancer (NSCLC): A Prospective, Multicenter, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This prospective, multicenter, randomized controlled trial aims to evaluate the clinical utility of DeepGEM, an artificial intelligence (AI)-based mutation prediction tool based on histopathological whole-slide images, in patients with non-small cell lung cancer (NSCLC). The study will assess whether DeepGEM can facilitate molecular testing, increase targeted therapy utilization, and improve survival outcomes in a real-world clinical setting. Patients with stage II-IV treatment-naïve NSCLC and qualified pathology slides for DeepGEM analysis will be enrolled. Eligible participants with AI-predicted EGFR, ALK, or ROS1 mutations will be randomized in a 4:1 ratio to either the DeepGEM-informed group (clinicians can access AI results to guide further testing and treatment) or the standard care group (clinicians are blinded to AI results and follow routine care).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 950 (estimated)
- First submitted
- 31 Jul 2025
- Start date
- 31 Jul 2025
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Jianxing He
- Diseases
- Lung cancer
- NCT number
- NCT07110259
What you commit to
- Study type: Interventional
- Planned participants: 950
- From 31 Jul 2025 to the primary completion date, 31 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy-including but not limited to monoclonal antibodies or tyrosine kinase inhibitors) before enrollment.
Other illness
- Failure of DeepGEM analysis or unqualified histopathological image quality.
- History of any other malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma (e.g., cervical carcinoma in situ).
- Any other clinical condition that, in the opinion of the investigators, may interfere with the study protocol or compromise participant safety, including poor compliance with study procedures.
Other
- Cognitive or psychological barriers to understanding or accepting AI-based prediction or molecular testing.
- Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception.
Who the study is looking for
- Age between 18 and 75 years, inclusive, at the time of enrollment.
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with clinical stage II-IV as per the 8th edition of the AJCC staging system.
- Availability of qualified histopathological whole-slide images that can be reviewed through the KindMED system(DeepGEM).
- Successful mutation prediction of EGFR, ALK, or ROS1 by the DeepGEM AI tool.
- No prior systemic anti-cancer therapy, including chemotherapy, targeted therapy, or immunotherapy.
- Willing and able to comply with study requirements, including follow-up and treatment; written informed consent must be provided.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.