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

Recruiting

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: Atezolizumab

• Registration Number: NCT05797493
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-04
• Study First Submitted: 2023-03-16
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-02
• Last Update Submitted: 2023-04-02
• Study First Posted: 2023-04-04
• Last Update Posted: 2023-04-04
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ES-SCLC	Atezolizumab	ES-SCLC receiving upfront chemo-immunotherapy

Primary Outcome Measures

Name	Time	Method
OS	Up to 60 months	Time from treatment start to the date of death from any cause, assessed up to 60 months
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

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Rome, Italy