Innovative immune assays for small cell lung cancer
Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05797493
This study is testing new ways to understand how the immune system responds in people with small cell lung cancer to see if it can help predict their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome) |
| Trial ID | NCT05797493 on ClinicalTrials.gov |
What this trial studies
This project utilizes a pan-omic approach to assess immune responses in patients with small cell lung cancer (SCLC). It involves comprehensive tumor characterization through genomic, proteomic, and transcriptomic analyses, alongside profiling of blood immune cells and cytokines. The aim is to validate the predictive role of SCLC transcriptomic classifications and explore correlations with changes in peripheral blood immunity and metabolic-induced inflammation. The study will focus on a real-world population to enhance understanding of immune responses in SCLC.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with extensive-stage SCLC who have received specific upfront treatments.
Not a fit: Patients with brain metastases at diagnosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved predictive models for treatment responses in small cell lung cancer patients.
How similar studies have performed: While similar approaches have been explored, this specific pan-omic methodology in SCLC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. histologically- or cytologically-documented extensive-stage SCLC 2. to have received upfront treatment with Cisplatin/Carboplatin, etoposide and anti PD1/PD-L1 inhibitors 3. No evidence of brain metastases at diagnosis 4. ECOG PS 0-2 5. adult patients (aged ≥ 18 years) at diagnosis; 6. signing of informed consent approved by the local Ethic Committee Exclusion Criteria: * none
Where this trial is running
Rome
- Fondazione Policlinico Gemelli IRCCS — Rome, Italy (RECRUITING)
Study contacts
- Study coordinator: Emilio Bria, Prof.
- Email: emilio.bria@policlinicogemelli.it
- Phone: +39 0630156318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Small Cell Lung Cancer, sclc, immunotherapy