Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential

Plain-language summary

This study examines a gene expression (transcriptional) framework that could help predict response to immunotherapy in lung cancer at the molecular level. It enrolls people over 18 with histologically confirmed non-small cell lung cancer, metastatic disease, and adequate tissue for molecular analysis. It is a non-phase study and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Regina Elena Cancer Institute

Start date

6/4/2024

Estimated completion

6/4/2026

Countries

Italy

Related genes

Locations

• Rome, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria cohort (NSCLC-IC):

* Age \>18 years;
* Histological diagnosis of NSCLC
* metastatic disease
* Availability, at the time of enrollment, of adequate biological material to be able to perform molecular analyses, taken (surgical or by biopsy) before administration of any anti-tumor treatment (chemotherapy and/or radiotherapy);
* ECOG PS 0-2;
* Adequate hematological, hepatic and renal function;
* Measurable disease according to RECIST criteria
* Availability of follow-up data for at least 6 months and/or until death/progression

Exclusion Criteria cohort (NSCLC-IC):

* Previous systemic therapy for metastatic disease;
* Comorbidities not controlled with adequate medical therapy.

Inclusion Criteria NSCLC-VC cohort:

* Age \>18 years;
* Histological diagnosis of NSCLC
* metastatic disease
* Availability, at the time of enrollment, of adequate biological material to be able to perform molecular analyses, taken (during surgery and/or by biopsy) before administration of any anti-tumor treatment (chemotherapy and/or radiotherapy);
* ECOG PS 0-2;
* Adequate hematological, hepatic and renal function;
* Measurable disease according to RECIST criteria;
* Written informed consent (participation in the study and data processing)

Exclusion Criteria NSCLC-VC cohort:

* Previous systemic treatment for metastatic disease;
* Comorbidities not controlled with adequate medical therapy;