Clinical trial · Observational
Immune Metabolism Dysregulation and Efficacy to Anti-PD-1 PD-L1 Agents in Non Small Cell Lung Cancer Patients
NCT07637474CI-TRIAL-00114020recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nsclc | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Serum collection
- description
- 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
- label
- Neoadjuvant treatment
- description
- 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.
- label
- Tissue samples
- description
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.