I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy

Launched by FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI, MILANO · Sep 8, 2022

Keywords

ClinConnect Summary

The I3LUNG clinical trial is focused on improving treatment for patients with advanced non-small cell lung cancer (NSCLC) by developing a new medical tool that can predict how well immunotherapy will work for them. The study involves collecting and analyzing data from around 200 patients, along with historical data from 2000 patients, to create a smart, user-friendly tool that doctors can use to make better treatment decisions. This tool aims to help reduce the side effects and overall costs of lung cancer treatments by identifying which patients are most likely to benefit from immunotherapy.

To participate in this trial, patients need to be at least 18 years old and have been diagnosed with stage IIIB/C-IV non-small cell lung cancer. They should have received immunotherapy or have a clinical indication for starting it. Patients with certain types of brain metastasis or specific genetic changes may also be eligible. Throughout the trial, participants can expect to be part of a study that collects data about their health and treatment experiences, helping to shape future lung cancer care. It's important for potential participants to understand the study procedures and provide consent before joining.

Gender

ALL

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