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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
950
Artificial intelligence-based mutation prediction using DeepGEM to guide clinical decision-making for molecular testing and therapy selection.
DeepGEM is used for eligibility screening, but its results are withheld. Clinicians manage patients per standard diagnostic and treatment practices.
Overall Survival (OS)
Comparison of OS between the DeepGEM-informed group and the standard care group.
Time frame: From randomization to death from any cause, assessed up to 36 months
Targeted Therapy Utilization Rate
Proportion of participants receiving molecularly matched targeted therapies based on standard genetic testing.
Time frame: Up to 6 months post-randomization
Molecular Testing Rate
Proportion of participants who undergo molecular testing after initial DeepGEM prediction.
Time frame: Up to 3 months
Prediction Concordance
Concordance between DeepGEM-predicted mutation status and results from PCR or NGS molecular testing.
Time frame: Up to 3 months
Cost-effectiveness of DeepGEM
Evaluation of cost per targeted therapy initiated and cost per life-year gained in the DeepGEM group versus standard care.
Time frame: Up to 12 months
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