Actively Recruiting
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)
Led by Intergroupe Francophone de Cancerologie Thoracique · Updated on 2024-03-08
300
Participants Needed
36
Research Sites
401 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Age 18 years or older.
- Pre-surgical disease evaluation including brain MRI/CT scan and total body PET-FDG CT scan.
- Complete anatomical resection (R0) of stage pIB-IIIA NSCLC.
- Presence of common EGFR mutation (Del19 or L858R).
- Archival tumor tissue FFPE blocks available from surgery for molecular analysis.
- Eligible for 3-year adjuvant osimertinib therapy; adjuvant chemotherapy allowed before osimertinib.
- Capable of complying with study requirements.
- Regular follow-up at the institution every 3 to 6 months.
- Estimated life expectancy greater than 3 years.
- Women of childbearing potential must have a negative pregnancy test before osimertinib and use effective contraception during treatment and for 2 months after.
- Men sexually active with women of childbearing potential must use effective contraception during treatment and for 4 months after last dose.
You will not qualify if you...
- History of cancer within the past 3 years, except in situ cervical carcinoma or non-melanoma skin carcinoma.
- Received neoadjuvant anti-cancer treatment before surgery (osimertinib, chemotherapy, or other treatments).
- Incomplete resection of NSCLC (R1 or R2).
- Any medical condition that would prevent participation in the study as judged by the investigator.
- Active infection including hepatitis C, HIV, or uncontrolled hepatitis B infection.
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Trial Site Locations
Total: 36 locations
1
Angers - CHU
Angers, France
Actively Recruiting
2
Bayonne - CH
Bayonne, France
Actively Recruiting
3
Boulogne - Ambroise Paré
Boulogne, France
Actively Recruiting
4
Lyon - URCOT
Bron, France
Actively Recruiting
5
Caen - CHU
Caen, France
Actively Recruiting
6
Clermont-Ferrand - CHU
Clermont-Ferrand, France
Actively Recruiting
7
Colmar - CH
Colmar, France
Actively Recruiting
8
Créteil - CHI
Créteil, France
Actively Recruiting
9
Dijon - CHU Bocage
Dijon, France
Actively Recruiting
10
Grenoble - CHU
Grenoble, France
Actively Recruiting
11
La Roche-Sur-Yon - CH
La Roche-sur-Yon, France
Actively Recruiting
12
Le Mans - CHG
Le Mans, France
Actively Recruiting
13
Lille - CHU
Lille, France
Actively Recruiting
14
Lyon - CRLCC
Lyon, France
Actively Recruiting
15
Marseille - APHM
Marseille, France
Actively Recruiting
16
Metz - Hôpital Robert Schuman
Metz, France
Actively Recruiting
17
Montpellier - CHU
Montpellier, France
Actively Recruiting
18
Montpellier - ICM
Montpellier, France
Actively Recruiting
19
Nice - CHU
Nice, France
Actively Recruiting
20
Orléans - CHR
Orléans, France
Actively Recruiting
21
Paris - Bichat
Paris, France
Actively Recruiting
22
Paris - HEGP
Paris, France
Actively Recruiting
23
Paris - Hôpital Cochin
Paris, France
Actively Recruiting
24
Paris - Pitié-Salpêtrière
Paris, France
Actively Recruiting
25
Paris - Tenon
Paris, France
Actively Recruiting
26
Pau - CHG
Pau, France
Actively Recruiting
27
Bordeaux - CHU
Pessac, France
Actively Recruiting
28
Poitiers - CHU
Poitiers, France
Actively Recruiting
29
Annecy - CH
Pringy, France
Actively Recruiting
30
Rennes - CHU
Rennes, France
Actively Recruiting
31
Rouen - CHU
Rouen, France
Actively Recruiting
32
Strasbourg - NHC
Strasbourg, France, 63000
Actively Recruiting
33
Suresnes - Foch
Suresnes, France
Actively Recruiting
34
Toulon - CHI
Toulon, France
Actively Recruiting
35
Toulouse - CHU
Toulouse, France
Actively Recruiting
36
Tours - CHU
Tours, France
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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