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

ConditionNsclc
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Histological diagnosis of advanced stage NSCLC

Histotype adenocarcinoma and squamous carcinoma

ECOG PS <2

Disqualifiers

Contraindications to immunotherapy

Unavailability of tumor tissue

Histotype with neuroendocrine or mixed component

Contraindication to immunotherapy

Trial population

Patients suffering from NSCLC lung cancer

Trial design

Design model

Family-based

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 3 trial groups
Group A: Serum collection
Group B: Neoadjuvant treatment
Group C: Tissue samples

Trial outcomes

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.

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Regina Elena Cancer Institute

Lead sponsor

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Collaborator