Small Cell Lung Cancer
Conditions
Keywords
sclc, immunotherapy
Brief summary
The scope of the PICASSO project is to apply an innovative patient-based pan-omic approach to immune-assays, that will include multi-omics tumour characterization (genome, proteome, transcriptome), blood immune-cells and cytokine profiling, serological screening for paraneoplastic autoantibodies, clinical and metabolic measurements. The PICASSO project is aimed to validate in real world population the predictive role of SCLC transcriptomic classification (particularly, I-SCLC subtype) and to explore correlations with dynamic changes in peripheral blood immunity. Additionally, investigators expected to validate the predictive/prognostic role of emerging new variables, including metabolic-induced meta-inflammation alterations and subclinical auto-immunity.
Interventions
DRUGAtezolizumab
Upfront chemo-immunotherapy
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Up to 60 months | Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
| OS | Up to 60 months | Time from treatment start to the date of death from any cause, assessed up to 60 months |
Countries
Italy
Contacts
Primary ContactEmilio Bria, Prof.
Outcome results
None listed