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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06053099
Other study ID # IFCT-2202
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 22, 2024
Est. completion date October 2031

Study information

Verified date March 2024
Source Intergroupe Francophone de Cancerologie Thoracique
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date October 2031
Est. primary completion date October 2031
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
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

Country Name City State
France 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

Sponsors (1)

Lead Sponsor Collaborator
Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility study Number of patients included receiving osimertinib after 18 months of enrollment 18 months
Secondary Incidence, nature, and severity of osimertinib-related adverse events (safety) Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). About 3 years
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