NCT06807307 Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential
| NCT ID | NCT06807307 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Elena Cancer Institute |
| Condition | NSCLC |
| Study Type | OBSERVATIONAL |
| Enrollment | 256 participants |
| Start Date | 2024-06-04 |
| Primary Completion | 2026-06-04 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Through genomic and transcriptomic sequencing techniques (whole exome sequencing, WES; whole transcriptome sequencing, WTS) patients with enrichment for KEAPness and specific gene interactions associated with it.
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