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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIntergroupe Francophone de Cancerologie Thoracique

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Plasma ctDNA
  • FFPE blocks

Treatment groups

300 Participants
are divided into 1 treatment group