PEOPLE (NTC03447678), a phase II trial to test pembrolizumab as first-line treatment in patients with advanced NSCLC with PD-L1 <50%: a multiomics analysis.
Giuseppe Lo Russo, Arsela Prelaj, James Dolezal...
https://pubmed.ncbi.nlm.nih.gov/37286305/Actively Recruiting
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2023-01-06
2200
Participants Needed
4
Research Sites
104 weeks
Total Duration
Researchers are developing a medical device using artificial intelligence to predict how well immunotherapy works in patients with non-small cell lung cancer NSCLC. The project combines data from past patients retrospective study and ongoing data collection from current patients prospective study. The aim is to create predictive models that help personalize treatment decisions, improve patient care, and reduce side effects and healthcare costs. The retrospective study includes data from over 2,000 patients, including clinical information and imaging scans like CT and PET, to build an initial predictive model. The prospective study collects detailed multi-omics data from about 200 patients to validate and improve this model, leading to a final tool called PDSS. This AI-based tool will help clinicians make better-informed treatment decisions by providing easy access to predictive information. Participants in the prospective study will provide biological samples for multi-omics analysis and undergo assessments during their treatment. Researchers will evaluate treatment response at 8 weeks using imaging scans and monitor progression-free survival and overall survival for up to 10 years. The project also aims to develop patient decision aids to support shared decision-making and improve communication between patients and doctors throughout the study duration.
CONDITIONS
I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
A
Arsela Prelaj, MD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead Sponsor
Vall d'Hebron Institute of Oncology
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Retrospective data from past records with no additional participant visits
Participants in the retrospective cohort have their clinical data and imaging scans collected and analyzed to build predictive models.
No visits required for retrospective data collection
Duration - During the prospective study period until data collection is complete
Participants in the prospective cohort provide multi-omics biological samples for analysis to validate predictive models.
Multiple visits as needed for sample and data collection
Duration - Up to 120 months
Participants in the prospective cohort are observed over time to assess outcomes such as progression and survival.
Follow-up visits according to clinical practice
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Giuseppe Lo Russo, Arsela Prelaj, James Dolezal...
https://pubmed.ncbi.nlm.nih.gov/37286305/Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead Sponsor
Vall d'Hebron Institute of Oncology
Collaborating Sponsor