NCT06807307Recruiting
Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential
KEAPnes: Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential
Source: ClinicalTrials.gov · Last updated 4 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 256 (estimated)
- First submitted
- 29 Jan 2025
- Start date
- 4 Jun 2024
- Primary completion date
- 4 Jun 2026
- Lead sponsor
- Regina Elena Cancer Institute
- Diseases
- Lung cancer
- NCT number
- NCT06807307
What you commit to
- Study type: Observational
- Planned participants: 256
- From 4 Jun 2024 to the primary completion date, 4 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous systemic therapy for metastatic disease;
- Comorbidities not controlled with adequate medical therapy.
- Previous systemic treatment for metastatic disease;
- Comorbidities not controlled with adequate medical therapy;
Who the study is looking for
- 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
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS National Cancer Institute "Regina Elena" Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.