Status:
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)
Lead Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Conditions:
Non Small Cell Lung Cancer
EGFR Activating Mutation
Eligibility:
All Genders
18+ years
Phase:
NA
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 pr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2031
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06053099
Start Date
January 22 2024
End Date
October 1 2031
Last Update
March 8 2024
Active Locations (36)
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1
Angers - CHU
Angers, France
2
Bayonne - CH
Bayonne, France
3
Boulogne - Ambroise Paré
Boulogne, France
4
Lyon - URCOT
Bron, France