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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
300
* 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
* Surgery FFPE blocks * FFPE blocks at relapse (optional)
Angers - CHU
Angers, France
RECRUITINGBayonne - CH
Bayonne, France
RECRUITINGBoulogne - Ambroise Paré
Boulogne, France
RECRUITINGLyon - URCOT
Bron, France
Feasibility study
Number of patients included receiving osimertinib after 18 months of enrollment
Time frame: 18 months
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).
Time frame: About 3 years
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Caen - CHU
Caen, France
RECRUITINGClermont-Ferrand - CHU
Clermont-Ferrand, France
RECRUITINGColmar - CH
Colmar, France
RECRUITINGCréteil - CHI
Créteil, France
RECRUITINGDijon - CHU Bocage
Dijon, France
RECRUITINGGrenoble - CHU
Grenoble, France
RECRUITING...and 26 more locations