Molecular diagnosis of lung cancer response to immunotherapy
Official title: KEAPnes: Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential
Run by Regina Elena Cancer Institute · NCT06807307 · Data updated 2026-11-12
This study is trying to see how the genes in lung cancer tumors affect how well patients respond to immunotherapy, with the hope of improving personalized treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 256 (estimated) |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | June 4, 2024 |
| Main results expected | June 4, 2026 |
| Study ends | June 4, 2026 |
| Registry record updated | February 4, 2025 |
| Trial ID | NCT06807307 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with a histological diagnosis of metastatic NSCLC who have adequate biological material for molecular analysis.
✕Probably not a fit
Patients who have previously received systemic therapy for metastatic disease or have uncontrolled comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to analyze genomic and transcriptomic data from patients with non-small cell lung cancer (NSCLC) to understand their response to immunotherapy. It involves collecting tissue samples and performing whole exome and transcriptome sequencing to identify specific gene interactions and tumor evolution over time. The study will also explore the immune subtypes associated with these genetic characteristics and use cell lines to identify potential new treatment vulnerabilities. The goal is to enhance personalized treatment strategies for lung cancer patients.
Why it matters
Potential benefit: If successful, this study could lead to more effective personalized immunotherapy options for lung cancer patients.
How similar studies have gone: Other studies have shown promise in using genomic and transcriptomic approaches for cancer treatment personalization, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria cohort (NSCLC-IC): * Age \>18 years; * Histological diagnosis of NSCLC * metastatic disease * Availability, at the time of enrollment, of adequate biological material to be able to perform molecular analyses, taken (surgical or by biopsy) before administration of any anti-tumor treatment (chemotherapy and/or radiotherapy); * ECOG PS 0-2; * Adequate hematological, hepatic and renal function; * Measurable disease according to RECIST criteria * Availability of follow-up data for at least 6 months and/or until death/progression Exclusion Criteria cohort (NSCLC-IC): * Previous systemic therapy for metastatic disease; * Comorbidities not controlled with adequate medical therapy. Inclusion Criteria NSCLC-VC cohort: * Age \>18 years; * Histological diagnosis of NSCLC * metastatic disease * Availability, at the time of enrollment, of adequate biological material to be able to perform molecular analyses, taken (during surgery and/or by biopsy) before administration of any anti-tumor treatment (chemotherapy and/or radiotherapy); * ECOG PS 0-2; * Adequate hematological, hepatic and renal function; * Measurable disease according to RECIST criteria; * Written informed consent (participation in the study and data processing) Exclusion Criteria NSCLC-VC cohort: * Previous systemic treatment for metastatic disease; * Comorbidities not controlled with adequate medical therapy;
Where it's running
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IRCCS National Cancer Institute "Regina Elena"
Rome, Italy Recruiting
Study contacts
- Study coordinator: Marcello Maugeri Saccà, Medical Doctor
- Email: marcello.maugerisacca@ifo.it
- Phone: +39 06 5266 6914
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.