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Recruiting NCT07363252

NCT07363252 Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients

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Clinical Trial Summary
NCT ID NCT07363252
Status Recruiting
Phase
Sponsor Gruppo Oncologico Italiano di Ricerca Clinica
Condition EGFR-mutated NSCLC
Study Type OBSERVATIONAL
Enrollment 100 participants
Start Date 2026-04-14
Primary Completion 2028-12

Trial Parameters

Condition EGFR-mutated NSCLC
Sponsor Gruppo Oncologico Italiano di Ricerca Clinica
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-04-14
Completion 2028-12
Interventions
Osimertinib

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Brief Summary

Retrospective-prospective observational multicentric study including radically resected EGFR-mutated NSCLC patients relapsed during or after adjuvant osimertinib, received according to clinical practice

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years * Diagnosis of radically resected IB-IIIA NSCLC with EGFR activating mutation * Treatment with adjuvant osimertinib (starting from September 2022, date of approval) according to clinical practice * Recurrence of disease during or after adjuvant therapy with osimertinib received according to clinical practice * Availability of tissue and/or liquid biopsy sample collected at the time of recurrence * Signed informed consent. * Exclusion Criteria: * Unavailability of tissue and/or liquid biopsy sample collected at the time of recurrence * Concomitant synchronous malignancies aside from NSCLC or any concurrent and/or active malignancy that has required treatment within 2 years * Involvement in the planning and/or conduct of the study (applies to both investigator staff and/or staff at the study site).

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