A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19)
IFCT-2202 ROSIE study aims to incorporate a broad-panel centralized NGS testing at baseline in all patients with completely resected NSCLC with common EGFR mutation after confirmation of an optimal preoperative extension assessment and with a centralized review of the quality of the surgical excision. Furthermore, the IFCT-2202 ROSIE study also aims to study the molecular events associated with relapse on, or after osimertinib exposure, that should result in the opportunity to accede to optimal treatment in case of metastatic relapse.
• Signed Informed consent.
• Age ≥ 18 years.
• Pre-surgical disease evaluation including brain MRI/CT-scan and total body PET-FDG CT-scan prior to surgery.
• Histologically complete anatomical resection (R0) of stage pIB-IIIA (pTNM 8th edition) NSCLC.
• Presence of a common EGFR mutation (Del19 or L858R).
• Archival tumour tissue FFPE blocks from surgery available for centrally molecular analyses.
• Patient eligible to receive osimertinib adjuvant therapy in a 3-year intent to treat decision; patients could receive if necessary adjuvant chemotherapy before starting osimertinib treatment.
• Patient who is capable, according to the investigator, of complying with the study's requirements and restrictions.
• Patient followed in the institution on a regular basis (every 3 to 6 months) according to standard recommendations.
⁃ Estimated life expectancy \> 3 years.
⁃ Woman patients who are of childbearing potential are eligible:
∙ They must have a negative pregnancy test before the first dose of osimertinib.
‣ They must agree to use effective methods of contraception throughout the course of treatment and should be maintained for 2 months after the end of treatment.
⁃ Male subjects who are sexually active with a woman of childbearing potential are eligible if an efficacious contraception method should be used during the treatment and during the 4 months following the last dose.