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
1 other identifier
interventional
300
1 country
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedStudy Start
First participant enrolled
January 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2031
March 8, 2024
March 1, 2024
7.7 years
August 18, 2023
March 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility study
Number of patients included receiving osimertinib after 18 months of enrollment
18 months
Secondary Outcomes (1)
Incidence, nature, and severity of osimertinib-related adverse events (safety)
About 3 years
Study Arms (1)
Plasma ctDNA and FFPE blocks
EXPERIMENTALInterventions
* 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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 63000, France
Suresnes - Foch
Suresnes, France
Toulon - CHI
Toulon, France
Toulouse - CHU
Toulouse, France
Tours - CHU
Tours, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2023
First Posted
September 25, 2023
Study Start
January 22, 2024
Primary Completion (Estimated)
October 1, 2031
Study Completion (Estimated)
October 1, 2031
Last Updated
March 8, 2024
Record last verified: 2024-03