Clinical Trials in Italy / NCT06807307
Recruiting
Observational
Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential
NCT06807307 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
NSCLC
Study 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
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;
Primary outcome measure(s)
- Innovative molecular tool — 24 months
To generate an innovative molecular tool for prediction DNA/RNA will be extracted from 5μm FFPE tissue sections using the AllPrep DNA/RNA FFPE kit (Qiagen). The quality of the RNA will be evaluated with the Bioanalyzer, the integrity of genomic DNA through the Agilent NGS FFPE qPCR QC Kit (Agilent). The libraries for RNA-Seq will be prepared using the RNA TruSeq Exome Kit (Illumina). The quality of the libraries resulting will be checked using Bioanalyzer (high sensitivity DNA kit). The intermediate library before exon enrichment will be quantified with Qubit, the final library with qPCR. The samples will be sequenced in paired-end mode, sequencing 76 bp on each side. The Exome DNA sequencing will be performed using SureSelectXT Low Input Kit reagents for the initial preparation of the library followed by enrichment with Clinical Research Exome Kit (Agilent).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCCS National Cancer Institute "Regina Elena" | Rome | Italy | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06807307 on ClinicalTrials.gov ↗ ← All trials in Italy