Immune Metabolism Dysregulation and Efficacy to Anti-PD-1 PD-L1 Agents in Non Small Cell Lung Cancer Patients

NCT07637474 | Recruiting

• 1 other identifier: RS196/IRE/24
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nsclc

Outcome Measures

Primary Outcomes (1)

• Overall survival OS

  The application of spatial transcriptomic approaches will enable the discovery of specific cellular niches that may be responsible for mechanisms of sensitivity or resistance to ICI. With the results you get, you will probably have a chance to locate it new and wonderful metabolic pathways capable of exerting their anti-tumor effect even in combination with ICIs.

  24 months

Study Arms (3)

Serum collection

Collection of sera/plasma from 400 patients, present in the Institute's Biobank. These are cells peripheral blood mononuclear cells (PBMC) and 150 tumor-infiltrating lymphocytes, cells immune cells that infiltrate adjacent non-tumor tissue and autologous CAFs from patients admitted to the IRE Institute for curative surgery. 20% of these patients relapse and access treatment Oncology Unit to be treated with immunotherapy according to the guidelines. This allows the availability on archive of tumor tissue, PBMC, CAF and TIL frozen at the time collected of the intervention who, at the time of progression, will begin treatment with ICIs according to clinical guidelines

Neoadjuvant treatment

Tissue taken will be collected, as per clinical practice, to curative surgery and when available to diagnostic biopsy. We plan to biobank in prospective manner: PBMC and plasma at the start of neoadjuvant treatment, the day before of surgery and during clinical follow-up with a pattern of every 3 months for at least 6 months of follow up and where possible up to 21 months. Evaluation of the response will be carried out by analysis of the pathological response in surgical tissue according to conventional criteria.

Tissue samples

Collection of fresh tissue samples from treatment-naïve patients undergoing surgery for NSCLC. Which will be prospectively biobanked, particularly PBMC and day-ahead plasma of the surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from NSCLC lung cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: collaborator

Study Sites (1)

IRCCS National Cancer institute

Rome, Rome, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples, blood samples and immune cells.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lorenza Landi, Doctor

  IRCCS National Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenza Landi, Doctor

CONTACT

06 5266 5699; lorenza.landi@ifo.it

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: June 9, 2026
• Study Start: July 24, 2024
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): July 24, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

IT (1)