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.
Neoadjuvant anti-cancer treatment (osimertinib and/or chemotherapy or other anti-cancer treatment).
Incompletely resected NSCLC (R1 or R2).
Any medical condition that would, according to the investigator's judgment, prevent the patient's participation in the clinical study.
Active infection (e.g. patients receiving treatment for infection) including hepatitis C virus (HCV) and human immunodeficiency virus (HIV), or active uncontrolled hepatitis B infection except for the situations described in APPENDIX I. Screening for chronic conditions is not required.
Single group
Plasma ctDNA
Other intervention* Plasma ctDNA before surgery (optional) * Plasma ctDNA post-surgery : 4 to 8 weeks post-surgery, before starting adjuvant chemotherapy (if given) and before starting adjuvant osimertinib (if given) * Plasma ctDNA every 6 months * Plasma ctDNA at relapse
FFPE blocks
Other intervention* Surgery FFPE blocks * FFPE blocks at relapse (optional)
Feasibility study
Number of patients included receiving osimertinib after 18 months of enrollment
Incidence, nature, and severity of osimertinib-related adverse events (safety)
Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
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