I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: PET scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Also, CT and PET scans will be collected and a first radiomic signature will be created to feed the R-Model."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
I3LUNG is developing and testing an AI-based tool to predict how well immunotherapy will work for adults with advanced non-small cell lung cancer. Immunotherapy helps the immune system fight cancer. The study uses past patient records and new health and lab data.
I3LUNG is an international project aiming to develop a medical device to predict immunotherapy efficacy for NSCLC patients using the integration of multisource data (real word and multi-omics data). This objective will be reached through a retrospective - setting up a transnational platform of available data from 2000 patients - and a prospective - multi-omics prospective data collection in 200 NSCLS patients - study phase. The retrospective cohort will be used to perform a preliminary knowledge extraction phase and to build a retrospective predictive model for IO (R-Model), that will be used in the prospective study phase to create a first version of the PDSS tool, an AI-based tool to provide an easy and ready-to-use access to predictive models, increasing care appropriateness, reducing the negative impacts of prolonged and toxic treatments on wellbeing and healthcare costs. The prospective part of the project includes the collection and the analysis of multi-OMICs data from a multicentric prospective cohort of about 200 patients. This cohort will be used to validate the results obtained from the retrospective model through the creation of a new model (P-Model), which will be used to create the final PDSS tool.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 or older.
- You can care for yourself and are out of bed or a chair for at least half of your waking hours.
- A tissue test confirms stage IIIB, IIIC, or IV non-small cell lung cancer.
- For the past-records group, you received immunotherapy at any treatment stage, including durvalumab maintenance treatment. For the new-data group, immunotherapy must be recommended as your first treatment.
- Cancer that has spread to the brain or spinal cord is allowed.
- Cancer-driving gene changes are allowed in the past-records group only.
- For the new-data group, you must sign and date a consent form showing you understand the study before joining.
- For the new-data group, at least one preserved tissue sample block must be available for lab testing.
Who can't join
- For the past-records group, your records lack the minimum treatment details needed.
- For the new-data group, you have already had treatment for advanced cancer.
- You are not available or cannot complete the required study steps, including surveys about your quality of life.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Age \>/= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status \</= 2. * Histologically confirmed diagnosis of stage IIIB/C-IV Non-Small-Cell Lung Cancer * Received any line immunotherapy (maintenance therapy with Durvalumab is allowed) for retrospective cohort; clinical indication for frontline treatment with immunotherapy as first line treatment for prospective cohort. * Patients with CNS metastasis are allowed * Patients with driver genomic alterations are allowed (only for retrospective cohort) * Evidence of a personally signed and dated ICF indicating that the patient has been informed of and understands all pertinent aspects of the study before enrolment (only for prospective cohort) * Availability of at least one FFPE block for -omics data generation (only for prospective cohort) Exclusion Criteria: * Patients without minimal treatment information data to be included in the retrospective cohort * Prior treatment for advanced disease (only for prospective cohort) * Unavailability or inability to comply with the requested study procedures, including compilation of QoL questionnaires
Study sites (1)
IL
- University of Chicago · Chicago, IL 60637Marina Garassino · Study contactMore trials in Chicago