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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 256 participants in total. It began in 2024-06-04 with a primary completion date of 2026-06-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06807307 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06807307 currently recruiting?
Yes, NCT06807307 is actively recruiting participants. Contact the research team at marcello.maugerisacca@ifo.it for enrollment information.
Where is the NCT06807307 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06807307 clinical trial?
NCT06807307 is sponsored by Regina Elena Cancer Institute. The trial plans to enroll 256 participants.