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Clinical Trials in Italy / NCT05797493
Recruiting Observational

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

NCT05797493 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2022-10-04
Last updated
2023-04-04

Condition(s) studied

Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Atezolizumab →

Atezolizumab: Upfront chemo-immunotherapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Gemelli IRCCS Rome Italy Recruiting

On this site

📄 Tecentriq (atezolizumab) drug profile →

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BRCA Mutation Carriers' Platform a Multicenter Study Recruiting
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Other trials for the same condition

Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab Recruiting
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer Recruiting
Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy Active, not recruiting
A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer Recruiting
Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05797493 on ClinicalTrials.gov ↗ ← All trials in Italy