Clinical trial NCT06053099: 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)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Small Cell Lung Cancer
EGFR Activating Mutation
EGFR DEL19
EGFR L858R
Keywords: IFCT
NSCLC
Adjuvant Osimertinib
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Feasibility study
timeFrame: 18 months
Secondary outcomes:
measure: Incidence, nature, and severity of osimertinib-related adverse events (safety)
timeFrame: About 3 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers - CHU
city: Bayonne
country: France
facility: Bayonne - CH
city: Boulogne
country: France
facility: Boulogne - Ambroise Paré
city: Bron
country: France
facility: Lyon - URCOT
city: Caen
country: France
facility: Caen - CHU
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand - CHU
city: Colmar
country: France
facility: Colmar - CH
city: Créteil
country: France
facility: Créteil - CHI
city: Dijon
country: France
facility: Dijon - CHU Bocage
city: Grenoble
country: France
facility: Grenoble - CHU
city: La Roche-sur-Yon
country: France
facility: La Roche-Sur-Yon - CH
city: Le Mans
country: France
facility: Le Mans - CHG
city: Lille
country: France
facility: Lille - CHU
city: Lyon
country: France
facility: Lyon - CRLCC
city: Marseille
country: France
facility: Marseille - APHM
city: Metz
country: France
facility: Metz - Hôpital Robert Schuman
city: Montpellier
country: France
facility: Montpellier - CHU
city: Montpellier
country: France
facility: Montpellier - ICM
city: Nice
country: France
facility: Nice - CHU
city: Orléans
country: France
facility: Orléans - CHR
city: Paris
country: France
facility: Paris - Bichat
city: Paris
country: France
facility: Paris - HEGP
city: Paris
country: France
facility: Paris - Hôpital Cochin
city: Paris
country: France
facility: Paris - Pitié-Salpêtrière
city: Paris
country: France
facility: Paris - Tenon
city: Pau
country: France
facility: Pau - CHG
city: Pessac
country: France
facility: Bordeaux - CHU
city: Poitiers
country: France
facility: Poitiers - CHU
city: Pringy
country: France
facility: Annecy - CH
city: Rennes
country: France
facility: Rennes - CHU
city: Rouen
country: France
facility: Rouen - CHU
city: Strasbourg
country: France
facility: Strasbourg - NHC
city: Suresnes
country: France
facility: Suresnes - Foch
city: Toulon
country: France
facility: Toulon - CHI
city: Toulouse
country: France
facility: Toulouse - CHU
city: Tours
country: France
facility: Tours - CHU
Study officials:
References: