Informations générales (source: ClinicalTrials.gov)
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) (ROSIE)
Interventional
N/A
Intergroupe Francophone de Cancerologie Thoracique (Voir sur ClinicalTrials)
janvier 2024
octobre 2031
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Alexandra BIZOT | 05/05/2025 07:12:14 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Marie WISLEZ | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Pr Jacques CADRANEL | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Angers - CHU - Angers - France | Youssef OULKHOUIR | Contact (sur clinicalTrials) | |||
| Annecy - CH - Pringy - France | Valérie PAULUS-JACQUEMET | Contact (sur clinicalTrials) | |||
| Bayonne - CH - Bayonne - France | Sophie SCHNEIDER | Contact (sur clinicalTrials) | |||
| Bordeaux - CHU - Pessac - France | Maéva ZYSMAN | Contact (sur clinicalTrials) | |||
| Boulogne - Ambroise Paré - Boulogne - France | Etienne GIROUX LEPRIEUR | Contact (sur clinicalTrials) | |||
| Caen - CHU - Caen - France | Jeannick MADELAINE | Contact (sur clinicalTrials) | |||
| Clermont-Ferrand - CHU - Clermont-Ferrand - France | Patrick MERLE | Contact (sur clinicalTrials) | |||
| Colmar - CH - Colmar - France | Lionel MOREAU | Contact (sur clinicalTrials) | |||
| Créteil - CHI - Créteil - France | Isabelle MONNET | Contact (sur clinicalTrials) | |||
| Dijon - CHU Bocage - Dijon - France | Ayoube ZOUAK | Contact (sur clinicalTrials) | |||
| Grenoble - CHU - Grenoble - France | Anne-Claire TOFFART | Contact (sur clinicalTrials) | |||
| La Roche-Sur-Yon - CH - La Roche-sur-Yon - France | Cyril GUIBERT | Contact (sur clinicalTrials) | |||
| Le Mans - CHG - Le Mans - France | Dr Camille GUGUEN | Contact (sur clinicalTrials) | |||
| Lille - CHU - Lille - France | Alexis CORTOT | Contact (sur clinicalTrials) | |||
| Lyon - CRLCC - Lyon - France | Virginie AVRILLON | Contact (sur clinicalTrials) | |||
| Lyon - URCOT - Bron - France | Thomas PIERRET | Contact (sur clinicalTrials) | |||
| Marseille - APHM - Marseille - France | Pascale TOMASINI | Contact (sur clinicalTrials) | |||
| Metz - Hôpital Robert Schuman - Metz - France | Benoît GODBERT, Dr | Contact (sur clinicalTrials) | |||
| Montpellier - CHU - Montpellier - France | Benoit ROCH | Contact (sur clinicalTrials) | |||
| Montpellier - ICM - Montpellier - France | Quentin THOMAS | Contact (sur clinicalTrials) | |||
| Nice - CHU - Nice - France | Jonathan BENZAQUEN | Contact (sur clinicalTrials) | |||
| Orléans - CHR - Orléans - France | Hugues MOREL | Contact (sur clinicalTrials) | |||
| Paris - HEGP - Paris - France | Elizabeth FABRE | Contact (sur clinicalTrials) | |||
| Paris - Pitié-Salpêtrière - Paris - France | Aurore VOZY | Contact (sur clinicalTrials) | |||
| Pau - CHG - Pau - France | Aldo RENAULT | Contact (sur clinicalTrials) | |||
| Poitiers - CHU - Poitiers - France | Clotilde DELDYCKE | Contact (sur clinicalTrials) | |||
| Rennes - CHU - Rennes - France | Charles RICORDEL | Contact (sur clinicalTrials) | |||
| Rouen - CHU - Rouen - France | Florian GUISIER | Contact (sur clinicalTrials) | |||
| Strasbourg - NHC - 63000 - Strasbourg - France | Céline MASCAUX, Dr | Contact (sur clinicalTrials) | |||
| Suresnes - Foch - Suresnes - France | Alexandra BIZOT | Contact (sur clinicalTrials) | |||
| Toulon - CHI - Toulon - France | Clarisse AUDIGIER-VALETTE | Contact (sur clinicalTrials) | |||
| Toulouse - CHU - Toulouse - France | Laurence BIGAY-GAME | Contact (sur clinicalTrials) | |||
| Tours - CHU - Tours - France | Delphine Carmier | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Signed Informed consent.
2. Age ≥ 18 years.
3. Pre-surgical disease evaluation including brain MRI/CT-scan and total body PET-FDG
CT-scan prior to surgery.
4. Histologically complete anatomical resection (R0) of stage pIB-IIIA (pTNM 8th
edition) NSCLC.
5. Presence of a common EGFR mutation (Del19 or L858R).
6. Archival tumour tissue FFPE blocks from surgery available for centrally molecular
analyses.
7. 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.
8. Patient who is capable, according to the investigator, of complying with the study's
requirements and restrictions.
9. Patient followed in the institution on a regular basis (every 3 to 6 months)
according to standard recommendations.
10. Estimated life expectancy > 3 years.
11. 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.
12. 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.
1. Signed Informed consent.
2. Age ≥ 18 years.
3. Pre-surgical disease evaluation including brain MRI/CT-scan and total body PET-FDG
CT-scan prior to surgery.
4. Histologically complete anatomical resection (R0) of stage pIB-IIIA (pTNM 8th
edition) NSCLC.
5. Presence of a common EGFR mutation (Del19 or L858R).
6. Archival tumour tissue FFPE blocks from surgery available for centrally molecular
analyses.
7. 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.
8. Patient who is capable, according to the investigator, of complying with the study's
requirements and restrictions.
9. Patient followed in the institution on a regular basis (every 3 to 6 months)
according to standard recommendations.
10. Estimated life expectancy > 3 years.
11. 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.
12. 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.
1. History of cancer, except for the following situations:
Patients with history of cancer for more than 3 years are eligible if they have been
treated and considered cured. Patients with history of in situ carcinoma of the
cervix or non-melanoma skin carcinoma are eligible.
2. Neoadjuvant anti-cancer treatment (osimertinib and/or chemotherapy or other
anti-cancer treatment).
3. Incompletely resected NSCLC (R1 or R2).
4. Any medical condition that would, according to the investigator's judgment, prevent
the patient's participation in the clinical study.
5. 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.