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Clinical Trials in Italy / NCT07637474
Recruiting Observational

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

NCT07637474 · tracked via the Priya Life Science Italy tracker
Sponsor
Regina Elena Cancer Institute
Phase
Observational
Started
2024-07-24
Last updated
2026-06-09

Condition(s) studied

Nsclc

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Overall survival OS — 24 months
    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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS National Cancer institute Rome Rome Recruiting

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Other trials for the same condition

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A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced Recruiting
A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study. Recruiting
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations Active, not 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 NCT07637474 on ClinicalTrials.gov ↗ ← All trials in Italy