Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

— PICASSO  

Official title:

Panomic Approach to Immune-Connected Assays in Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797493
• Other study ID #: 5061
• Status: Recruiting
• Start date: October 4, 2022
• Est. completion date: June 2027

Study information

• Verified date: April 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Emilio Bria, Prof.
• Phone: +39 0630156318
• Email: emilio.bria[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Atezolizumab
Upfront chemo-immunotherapy

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	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	Up to 60 months
Primary	OS	Time from treatment start to the date of death from any cause, assessed up to 60 months	Up to 60 months