RecruitingNot ApplicableNCT06053099

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)


Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Enrollment

300 participants

Start Date

Jan 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study follows lung cancer patients with specific EGFR gene mutations who are receiving osimertinib (a targeted therapy) after having their tumors surgically removed. Researchers are collecting molecular data to understand why some patients respond well and others develop resistance to the drug. **You may be eligible if...** - You are 18 or older - You had your lung cancer completely removed by surgery (stage IB–IIIA) - Your tumor has a common EGFR mutation (a deletion in exon 19 or L858R) - You are scheduled to receive osimertinib as preventive (adjuvant) therapy - Your surgical tumor tissue is available for molecular analysis **You may NOT be eligible if...** - You have an uncommon or rare EGFR mutation type - Your cancer was not completely removed (positive margins) - You are not regularly followed at the participating institution - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPlasma 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

OTHERFFPE blocks

* Surgery FFPE blocks * FFPE blocks at relapse (optional)


Locations(36)

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, France

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NCT06053099


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