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Recruiting NCT06807307

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

— Observational NSCLC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: NSCLC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

Retrospective-prospective, non-pharmacological, biological, multicenter observational study, for which the collection and use of tissue samples from patients suffering from NSCLC and/or other tumor types. 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. Subsequently, through the same techniques, applied to different tumor regions taken from operating site it will be possible to identify the evolution of the tumor at a spatio-temporal level and the immune subtype associated with the presence/absence of KEAPness. Finally, cell lines will be used to recapitulate what was observed in the patient and per-patient cohorts identify new pharmacological vulnerabilities associated with the characteristics of KEAPness.

Primary outcome measures

  • Innovative molecular tool [Time frame: 24 months]
Secondary outcome measures (2)
  • Tracing the evolutionary path [Time frame: 24 months]
  • Identification of therapeutic vulnerabilities specific [Time frame: 24 months]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • IRCCS National Cancer Institute "Regina Elena" — Rome

Identifiers

NCT: NCT06807307 · RS158/IRE/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗