Immune Metabolism Dysregulation and Efficacy to Anti-PD-1 PD-L1 Agents in Non Small Cell Lung Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Nsclc. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Prospective, biological, observational study involving the collection and use of samples from patients suffering from NSCLC lung cancer, aimed at comparing the molecular profile related to metabolism among subjects with response or resistance to checkpoint inhibitors immune system (ICI), in order to contribute to define response biomarkers and new molecular pathways as therapeutic targets combine with ICI to overcome resistance.
Detailed description
This study aims to identify the metabolic pathways related to the tumor microenvironment in NSCLC patients and their role in the response to ICI.
To this end, the metabolic picture will be evaluated on tumor-associated fibroblasts and macrophages tumor-associated and tumor-infiltrating lymphocytes, obtained from tissue samples of two different cohorts of patients candidate to receive immune-checkpoint treatment inhibitors. Furthermore it will correlate metabolic alterations in tumor tissues and peripheral immune cells or in plasma proteins of NSCLC patients with clinical response to ICIs.
For this purpose, serum/plasma and peripheral blood mononuclear cells (PBMC) will be isolated from the peripheral blood of patients to carry out phenotypic, metabolic and transcriptional studies on cells peripheral immune system. Finally it will come explored the therapeutic modulation of metabolic signatures identified in ex vivo models, using organoids and cultures of organotypic tissue sections obtained from patients affected by NSCLC, subjected to curative surgical treatment and treatment naive.
Primary outcome measures
- Overall survival OS [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Age > 18 years
- Histological diagnosis of advanced stage NSCLC
- Histotype adenocarcinoma and squamous carcinoma
- ECOG PS <2
- Known PDL-1 stage
- Measurable disease
- Availability of tumor tissue
- No evidence of molecular drivers
- Written informed consent (to the study and data processing)
For the second cohort in addition to the precedents it is included
- Diagnosis of limited or locally advanced NSCLC deemed resectable
For the third cohort in addition to the precedents it is included
- patients candidates for surgery for non-small cell lung cancer
Exclusion criteria
- Contraindications to immunotherapy
- Unavailability of tumor tissue
- Histotype with neuroendocrine or mixed component
For the second cohort
- Contraindication to immunotherapy
- Histotype with neuroendocrine or mixed component
- Locally advanced disease candidate for concomitant chemo-radiotherapy treatment
For the third cohort
- previously treated patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Family-based
Study locations
Italy · 1 center
- IRCCS National Cancer institute — Rome
Identifiers
NCT: NCT07637474 · RS196/IRE/24