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)

Last updated: March 6, 2024
Sponsor: Intergroupe Francophone de Cancerologie Thoracique
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

FFPE blocks

Plasma ctDNA

Clinical Study ID

NCT06053099
IFCT-2202
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Signed Informed consent.
  2. Age ≥ 18 years.
  3. Pre-surgical disease evaluation including brain MRI/CT-scan and total body PET-FDGCT-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 molecularanalyses.
  7. Patient eligible to receive osimertinib adjuvant therapy in a 3-year intent to treatdecision; patients could receive if necessary adjuvant chemotherapy before startingosimertinib treatment.
  8. Patient who is capable, according to the investigator, of complying with the study'srequirements and restrictions.
  9. Patient followed in the institution on a regular basis (every 3 to 6 months) accordingto 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 courseof treatment and should be maintained for 2 months after the end of treatment.
  1. Male subjects who are sexually active with a woman of childbearing potential areeligible if an efficacious contraception method should be used during the treatmentand during the 4 months following the last dose.

Exclusion

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 beentreated and considered cured. Patients with history of in situ carcinoma of the cervixor non-melanoma skin carcinoma are eligible.
  2. Neoadjuvant anti-cancer treatment (osimertinib and/or chemotherapy or otheranti-cancer treatment).
  3. Incompletely resected NSCLC (R1 or R2).
  4. Any medical condition that would, according to the investigator's judgment, preventthe patient's participation in the clinical study.
  5. Active infection (e.g. patients receiving treatment for infection) including hepatitisC virus (HCV) and human immunodeficiency virus (HIV), or active uncontrolled hepatitisB infection except for the situations described in APPENDIX I. Screening for chronicconditions is not required.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: FFPE blocks
Phase:
Study Start date:
January 22, 2024
Estimated Completion Date:
October 31, 2031

Connect with a study center

  • Angers - CHU

    Angers,
    France

    Active - Recruiting

  • Bayonne - CH

    Bayonne,
    France

    Active - Recruiting

  • Boulogne - Ambroise Paré

    Boulogne,
    France

    Active - Recruiting

  • Lyon - URCOT

    Bron,
    France

    Active - Recruiting

  • Caen - CHU

    Caen,
    France

    Active - Recruiting

  • Clermont-Ferrand - CHU

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Colmar - CH

    Colmar,
    France

    Active - Recruiting

  • Créteil - CHI

    Créteil,
    France

    Active - Recruiting

  • Dijon - CHU Bocage

    Dijon,
    France

    Active - Recruiting

  • Grenoble - CHU

    Grenoble,
    France

    Active - Recruiting

  • La Roche-Sur-Yon - CH

    La Roche-sur-Yon,
    France

    Active - Recruiting

  • Le Mans - CHG

    Le Mans,
    France

    Active - Recruiting

  • Lille - CHU

    Lille,
    France

    Active - Recruiting

  • Lyon - CRLCC

    Lyon,
    France

    Active - Recruiting

  • Marseille - APHM

    Marseille,
    France

    Active - Recruiting

  • Metz - Hôpital Robert Schuman

    Metz,
    France

    Active - Recruiting

  • Montpellier - CHU

    Montpellier,
    France

    Active - Recruiting

  • Montpellier - ICM

    Montpellier,
    France

    Active - Recruiting

  • Nice - CHU

    Nice,
    France

    Active - Recruiting

  • Orléans - CHR

    Orléans,
    France

    Active - Recruiting

  • Paris - Bichat

    Paris,
    France

    Active - Recruiting

  • Paris - HEGP

    Paris,
    France

    Active - Recruiting

  • Paris - Hôpital Cochin

    Paris,
    France

    Active - Recruiting

  • Paris - Pitié-Salpêtrière

    Paris,
    France

    Active - Recruiting

  • Paris - Tenon

    Paris,
    France

    Active - Recruiting

  • Pau - CHG

    Pau,
    France

    Active - Recruiting

  • Bordeaux - CHU

    Pessac,
    France

    Active - Recruiting

  • Poitiers - CHU

    Poitiers,
    France

    Active - Recruiting

  • Annecy - CH

    Pringy,
    France

    Active - Recruiting

  • Rennes - CHU

    Rennes,
    France

    Active - Recruiting

  • Rouen - CHU

    Rouen,
    France

    Active - Recruiting

  • Strasbourg - NHC

    Strasbourg, 63000
    France

    Active - Recruiting

  • Suresnes - Foch

    Suresnes,
    France

    Active - Recruiting

  • Toulon - CHI

    Toulon,
    France

    Active - Recruiting

  • Toulouse - CHU

    Toulouse,
    France

    Active - Recruiting

  • Tours - CHU

    Tours,
    France

    Active - Recruiting

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