Immune Metabolism in NSCLC and Response to PD-1/PD-L1 Inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study collects tumor tissue and blood samples from adults with advanced NSCLC to explore how metabolic pathways in the tumor microenvironment relate to responses to immune-checkpoint inhibitors. Researchers will analyze tumor-associated fibroblasts, macrophages, and immune cells in tissues and peripheral blood, linking metabolic and transcriptional features to clinical outcomes. Additional work will test whether identified metabolic signatures can be modulated in ex vivo models using organoids and tissue sections. The study may help identify biomarkers of response and new metabolic targets to overcome resistance to ICIs.

Why it matters

Who can join: the full rules

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

Where it's running

• IRCCS National Cancer institute
  Rome, Rome, Italy Recruiting

Study contacts

• Principal investigator: Lorenza Landi, Doctor — IRCCS National Cancer Institute
• Study coordinator: Lorenza Landi, Doctor
• Email: lorenza.landi@ifo.it
• Phone: 06 5266 5699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.