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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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