Immune Metabolism Dysregulation and Efficacy to Anti-PD-1 PD-L1 Agents in Non Small Cell Lung Cancer Patients
Recruiting · NCT07637474 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- IRCCS National Cancer institute - Rome, Rome, Italy