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)

Non Small Cell Lung Cancer Clinical Trial

— ROSIE  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053099
• Other study ID #: IFCT-2202
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Activating Mutation
• Lung Neoplasms
• Non Small Cell Lung Cancer

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