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) (ROSIE)

March 6, 2024 updated by: Intergroupe Francophone de Cancerologie Thoracique
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Recruiting
        • Angers - CHU
        • Principal Investigator:
          • Youssef OULKHOUIR, Dr
        • Contact:
      • Bayonne, France
        • Recruiting
        • Bayonne - CH
        • Contact:
        • Principal Investigator:
          • Sophie SCHNEIDER, Dr
      • Boulogne, France
        • Recruiting
        • Boulogne - Ambroise Paré
        • Principal Investigator:
          • Etienne GIROUX LEPRIEUR, Pr
        • Contact:
          • Etienne GIROUX LEPRIEUR
          • Phone Number: +33 1.56.81.10.45
          • Email: contact@ifct.fr
      • Bron, France
        • Recruiting
        • Lyon - URCOT
        • Contact:
        • Principal Investigator:
          • Thomas PIERRET, Dr
      • Caen, France
        • Recruiting
        • Caen - CHU
        • Contact:
          • Jeannick MADELAINE
          • Phone Number: +33 1.56.81.10.45
          • Email: contact@ifct.fr
        • Principal Investigator:
          • Jeannick MADELAINE, Dr
      • Clermont-Ferrand, France
        • Recruiting
        • Clermont-Ferrand - CHU
        • Contact:
        • Principal Investigator:
          • Patrick MERLE
      • Colmar, France
        • Recruiting
        • Colmar - CH
        • Principal Investigator:
          • Lionel MOREAU, Dr
        • Contact:
      • Créteil, France
        • Recruiting
        • Créteil - CHI
        • Contact:
        • Principal Investigator:
          • Isabelle MONNET, Dr
      • Dijon, France
        • Recruiting
        • Dijon - CHU Bocage
        • Principal Investigator:
          • Ayoube ZOUAK, Dr
        • Contact:
      • Grenoble, France
        • Recruiting
        • Grenoble - CHU
        • Contact:
          • Anne-Claire TOFFART
          • Phone Number: +33 1.56.81.10.45
          • Email: contact@ifct.fr
        • Principal Investigator:
          • Anne-Claire TOFFART, Pr
      • La Roche-sur-Yon, France
        • Recruiting
        • La Roche-Sur-Yon - CH
        • Contact:
        • Principal Investigator:
          • Cyril GUIBERT, Dr
      • Le Mans, France
        • Recruiting
        • Le Mans - CHG
        • Contact:
        • Principal Investigator:
          • Dr Camille GUGUEN, Dr
      • Lille, France
        • Recruiting
        • Lille - CHU
        • Contact:
        • Sub-Investigator:
          • Alexis CORTOT, Pr
      • Lyon, France
        • Recruiting
        • Lyon - CRLCC
        • Contact:
        • Principal Investigator:
          • Virginie AVRILLON, Dr
      • Marseille, France
        • Recruiting
        • Marseille - APHM
        • Contact:
        • Principal Investigator:
          • Pascale TOMASINI, Dr
      • Metz, France
        • Recruiting
        • Metz - Hôpital Robert Schuman
        • Principal Investigator:
          • Benoit Godbert
        • Contact:
          • Benoît GODBERT, Dr
          • Phone Number: +33 1.56.81.10.45
          • Email: contact@ifct.fr
      • Montpellier, France
        • Recruiting
        • Montpellier - CHU
        • Contact:
        • Principal Investigator:
          • Benoit ROCH, Dr
      • Montpellier, France
        • Recruiting
        • Montpellier - ICM
        • Contact:
        • Principal Investigator:
          • Quentin THOMAS, Dr
      • Nice, France
        • Recruiting
        • Nice - CHU
        • Contact:
          • Jonathan BENZAQUEN
          • Phone Number: +33 1.56.81.10.45
          • Email: contact@ifct.fr
        • Principal Investigator:
          • Jonathan BENZAQUEN, Dr
      • Orléans, France
        • Recruiting
        • Orléans - CHR
        • Contact:
        • Principal Investigator:
          • Hugues MOREL, Dr
      • Paris, France
        • Recruiting
        • Paris - Hôpital Cochin
        • Principal Investigator:
          • Marie WISLEZ, Pr
        • Contact:
      • Paris, France
        • Recruiting
        • Paris - Bichat
        • Contact:
        • Principal Investigator:
          • Gérard ZALCMAN, Pr
      • Paris, France
        • Recruiting
        • Paris - Tenon
        • Contact:
          • Pr Jacques CADRANEL
          • Phone Number: +33 1.56.81.10.45
          • Email: contact@ifct.fr
        • Principal Investigator:
          • Pr Jacques CADRANEL, Pr
      • Paris, France
        • Recruiting
        • Paris - HEGP
        • Contact:
        • Principal Investigator:
          • Elizabeth FABRE, Dr
      • Paris, France
        • Recruiting
        • Paris - Pitié-Salpêtrière
        • Contact:
        • Principal Investigator:
          • Aurore VOZY, Dr
      • Pau, France
        • Recruiting
        • Pau - CHG
        • Contact:
        • Principal Investigator:
          • Aldo RENAULT, Dr
      • Pessac, France
        • Recruiting
        • Bordeaux - CHU
        • Contact:
        • Principal Investigator:
          • Maéva ZYSMAN, Dr
      • Poitiers, France
        • Recruiting
        • Poitiers - CHU
        • Contact:
        • Principal Investigator:
          • Clotilde DELDYCKE, Dr
      • Pringy, France
        • Recruiting
        • Annecy - CH
        • Contact:
          • Valérie PAULUS-JACQUEMET
          • Phone Number: +33 1.56.81.10.45
          • Email: contact@ifct.fr
        • Principal Investigator:
          • Valérie PAULUS-JACQUEMET, Dr
      • Rennes, France
        • Recruiting
        • Rennes - CHU
        • Principal Investigator:
          • Charles RICORDEL, Dr
        • Contact:
      • Rouen, France
        • Recruiting
        • Rouen - CHU
        • Contact:
        • Principal Investigator:
          • Florian GUISIER, Pr
      • Strasbourg, France, 63000
        • Recruiting
        • Strasbourg - NHC
        • Contact:
          • Céline MASCAUX, Dr
          • Phone Number: +33 1.56.81.10.45
          • Email: contact@ifct.fr
        • Principal Investigator:
          • Céline MASCAUX, Pr
      • Suresnes, France
        • Recruiting
        • Suresnes - Foch
        • Contact:
        • Principal Investigator:
          • Alexandra BIZOT, Dr
      • Toulon, France
        • Recruiting
        • Toulon - CHI
        • Contact:
          • Clarisse AUDIGIER-VALETTE
          • Phone Number: +33 1.56.81.10.45
          • Email: contact@ifct.fr
        • Principal Investigator:
          • Clarisse AUDIGIER-VALETTE, Dr
      • Toulouse, France
        • Recruiting
        • Toulouse - CHU
        • Contact:
          • Laurence BIGAY-GAME
          • Phone Number: +33 1.56.81.10.45
          • Email: contact@ifct.fr
        • Principal Investigator:
          • Laurence BIGAY-GAME, Dr
      • Tours, France
        • Recruiting
        • Tours - CHU
        • Contact:
        • Principal Investigator:
          • Delphine Carmier, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed Informed consent.
  2. Age ≥ 18 years.
  3. Pre-surgical disease evaluation including brain MRI/CT-scan and total body PET-FDG CT-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 molecular analyses.
  7. 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.
  8. Patient who is capable, according to the investigator, of complying with the study's requirements and restrictions.
  9. Patient followed in the institution on a regular basis (every 3 to 6 months) according to 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 course of treatment and should be maintained for 2 months after the end of treatment.
  12. 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 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 been treated and considered cured. Patients with history of in situ carcinoma of the cervix or non-melanoma skin carcinoma are eligible.

  2. Neoadjuvant anti-cancer treatment (osimertinib and/or chemotherapy or other anti-cancer treatment).
  3. Incompletely resected NSCLC (R1 or R2).
  4. Any medical condition that would, according to the investigator's judgment, prevent the patient's participation in the clinical study.
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plasma ctDNA and FFPE blocks
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility study
Time Frame: 18 months
Number of patients included receiving osimertinib after 18 months of enrollment
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence, nature, and severity of osimertinib-related adverse events (safety)
Time Frame: About 3 years
Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
About 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Estimated)

October 1, 2031

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-2202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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