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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer
• EGFR Activating Mutation
• EGFR DEL19
• EGFR L858R

Interventions

Type	Name	Description
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
OTHER	FFPE blocks	* Surgery FFPE blocks * FFPE blocks at relapse (optional)

Timeline

• Start date: 2024-01-22
• Primary completion: 2031-10-01
• Completion: 2031-10-01
• First posted: 2023-09-25
• Last updated: 2024-03-08

Locations

36 sites across 1 country: France