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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)
Sponsor: Intergroupe Francophone de Cancerologie Thoracique
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-01-22
Completion Date
2031-10
Last Updated
2024-03-08
Healthy Volunteers
No
Interventions
Plasma ctDNA
* 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
* Surgery FFPE blocks * FFPE blocks at relapse (optional)
Locations (36)
Angers - CHU
Angers, France
Bayonne - CH
Bayonne, France
Boulogne - Ambroise Paré
Boulogne, France
Lyon - URCOT
Bron, France
Caen - CHU
Caen, France
Clermont-Ferrand - CHU
Clermont-Ferrand, France
Colmar - CH
Colmar, France
Créteil - CHI
Créteil, France
Dijon - CHU Bocage
Dijon, France
Grenoble - CHU
Grenoble, France
La Roche-Sur-Yon - CH
La Roche-sur-Yon, France
Le Mans - CHG
Le Mans, France
Lille - CHU
Lille, France
Lyon - CRLCC
Lyon, France
Marseille - APHM
Marseille, France
Metz - Hôpital Robert Schuman
Metz, France
Montpellier - CHU
Montpellier, France
Montpellier - ICM
Montpellier, France
Nice - CHU
Nice, France
Orléans - CHR
Orléans, France
Paris - Bichat
Paris, France
Paris - HEGP
Paris, France
Paris - Hôpital Cochin
Paris, France
Paris - Pitié-Salpêtrière
Paris, France
Paris - Tenon
Paris, France
Pau - CHG
Pau, France
Bordeaux - CHU
Pessac, France
Poitiers - CHU
Poitiers, France
Annecy - CH
Pringy, France
Rennes - CHU
Rennes, France
Rouen - CHU
Rouen, France
Strasbourg - NHC
Strasbourg, France
Suresnes - Foch
Suresnes, France
Toulon - CHI
Toulon, France
Toulouse - CHU
Toulouse, France
Tours - CHU
Tours, France