Retrospective-prospective observational multicentric study including radically resected EGFR-mutated NSCLC patients relapsed during or after adjuvant osimertinib, received according to clinical practice
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
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).
100 relapsed EGFR-mutated NSCLC patient receiving osimertinib in adjuvant setting and with tissue biopsy and/or liquid biopsy collected at the time of recurrence
Cohort
Other
Osimertinib
DrugCharacterization of the molecular mechanisms of recurrence to adjuvant osimertinib
The primary endpoint of the study is the frequency of new variant(s) detected by Next Generation Sequencing (NGS) Panel at the time of recurrence to adjuvant osimertinib in tissue and/or liquid biopsy
The primary endpoint of the study is the frequency of new variant(s) detected by Next Generation Sequencing (NGS) Panel at the time of recurrence to adjuvant osimertinib in tissue and/or liquid biopsy
Secondary endpoint
• Frequency of new variant(s) in Next Generation Sequencing (NGS) Panel in tissue sample at the time of recurrence to adjuvant osimertinib compared to surgical/pre-osimertinib sample
Secondary endpoint
• percent of treatment options at disease relapse
Secondary endpoint
• Correlation of new variants in NGS and clinical features to the onset of recurrence (on treatment/off treatment)
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