Molecular diagnosis of lung cancer response to immunotherapy

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

This study is trying to see how the genes in lung cancer tumors affect how well patients respond to immunotherapy, with the hope of improving personalized treatment options.

Quick facts

• Study type: Observational
• Enrollment: 256 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Regina Elena Cancer Institute (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Rome)
• Trial ID: NCT06807307 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze genomic and transcriptomic data from patients with non-small cell lung cancer (NSCLC) to understand their response to immunotherapy. It involves collecting tissue samples and performing whole exome and transcriptome sequencing to identify specific gene interactions and tumor evolution over time. The study will also explore the immune subtypes associated with these genetic characteristics and use cell lines to identify potential new treatment vulnerabilities. The goal is to enhance personalized treatment strategies for lung cancer patients.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a histological diagnosis of metastatic NSCLC who have adequate biological material for molecular analysis.

Not a fit: Patients who have previously received systemic therapy for metastatic disease or have uncontrolled comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective personalized immunotherapy options for lung cancer patients.

How similar studies have performed: Other studies have shown promise in using genomic and transcriptomic approaches for cancer treatment personalization, indicating potential success for this approach.

Eligibility criteria

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;

Where this trial is running

Rome

• IRCCS National Cancer Institute "Regina Elena" — Rome, Italy (Recruiting)

Study contacts

• Study coordinator: Marcello Maugeri Saccà, Medical Doctor

Conditions NSCLC