Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients
Заболявания:
EGFR-mutated NSCLC
Спонсор: Gruppo Oncologico Italiano di Ricerca Clinica
Налично на:
БГ
Обобщение
Retrospective-prospective observational multicentric study including radically resected EGFR-mutated NSCLC patients relapsed during or after adjuvant osimertinib, received according to clinical practice
Описание
This study will include patients
1. who have already received adjuvant osimertinib and who relapsed at the end of the treatment (off-treatment recurrence) and patients
2. who relapsed during the treatment (on-treatment recurrence). Patients could be enrolled at the time or after the recurrence. Data regarding clinical features for each patient, including demographics and comorbidities, and clinical outcomes of adjuvant osimertinib will be collected.
NGS analysis will be centrally performed on tissue biopsy and/or liquid biopsy collected at the time of recurrence in EGFR-mutated NSCLC treated with adjuvant osimertinib. NGS will be also centrally performed on tissue samples collected at the time of surgery.
Кой може да участва
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).
Интервенции
Osimertinib
DRUG
Места на провеждане
25
Италия (25)
S.O.C. di Oncologia Medica e dei Tumori Immuno-correlati, Centro di Riferimento Oncologico IRCCS
Aviano , PN
NOT_YET_RECRUITING
IRCCS Oncologico Giovanni Paolo II
Bari , BA
ACTIVE_NOT_RECRUITING
Asst Papa Giovanni Xxiii Sc Oncologia
Bergamo , BG
NOT_YET_RECRUITING
UOC di Oncologia Medica IRCCS - Policlinico S. Orsola Malpighi
Bologna , BO
NOT_YET_RECRUITING
Grande Ospedale Metropolitano Niguarda Ca' Granda
Milan , Michigan
ACTIVE_NOT_RECRUITING
Irccs Humanitas Research Hospital
Milan , MI
NOT_YET_RECRUITING
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan , MI
NOT_YET_RECRUITING
Ospedale San Raffaele Dipartimento di Oncologia Medica
БГ
EN