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Non Small Cell Lung CancerROSIENCT06053099

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)

A study testing Plasma ctDNA and FFPE blocks in people with Non Small Cell Lung Cancer and EGFR Activating Mutation, run by Intergroupe Francophone de Cancerologie Thoracique at 36 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Plasma ctDNA and FFPE blocks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
36 sitesFrance
Study dates
22 Jan 2024to Oct 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed consent.
  • Age ≥ 18 years.
  • Pre-surgical disease evaluation including brain MRI/CT-scan and total body PET-FDG CT-scan prior to surgery.
  • Histologically complete anatomical resection (R0) of stage pIB-IIIA (pTNM 8th edition) NSCLC.
  • Presence of a common EGFR mutation (Del19 or L858R).
  • Archival tumour tissue FFPE blocks from surgery available for centrally molecular analyses.
Show all 14Show fewer
  • 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.
  • Patient who is capable, according to the investigator, of complying with the study's requirements and restrictions.
  • Patient followed in the institution on a regular basis (every 3 to 6 months) according to standard recommendations.
  • Estimated life expectancy > 3 years.
  • 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.
  • 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.

Who cannot join

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

Trial locations and contacts

36 sites in 1 country. Contact the study team or a site near you to ask about taking part.

36 sites in 1 country

France36 sites, 36 recruiting

  • Angers - CHU

    Angers

    Youssef OULKHOUIR, +33 1.56.81.10.45, contact@ifct.fr

    Youssef OULKHOUIR, Dr

    Recruiting

  • Bayonne - CH

    Bayonne

    Sophie SCHNEIDER, +33 1.56.81.10.45, contact@ifct.fr

    Sophie SCHNEIDER, Dr

    Recruiting

  • Boulogne - Ambroise Paré

    Boulogne

    Etienne GIROUX LEPRIEUR, +33 1.56.81.10.45, contact@ifct.fr

    Etienne GIROUX LEPRIEUR, Pr

    Recruiting

  • Lyon - URCOT

    Bron

    Thomas PIERRET, +33 1.56.81.10.45, contact@ifct.fr

    Thomas PIERRET, Dr

    Recruiting

  • Caen - CHU

    Caen

    Jeannick MADELAINE, +33 1.56.81.10.45, contact@ifct.fr

    Jeannick MADELAINE, Dr

    Recruiting

  • Clermont-Ferrand - CHU

    Clermont-Ferrand

    Patrick MERLE, +33 1.56.81.10.45, contact@ifct.fr

    Patrick MERLE

    Recruiting

  • Colmar - CH

    Colmar

    Lionel MOREAU, +33 1.56.81.10.45, contact@ifct.fr

    Lionel MOREAU, Dr

    Recruiting

  • Créteil - CHI

    Créteil

    Isabelle MONNET, +33 1.56.81.10.45, contact@ifct.fr

    Isabelle MONNET, Dr

    Recruiting

  • Dijon - CHU Bocage

    Dijon

    Ayoube ZOUAK, +33 1.56.81.10.45, contact@ifct.fr

    Ayoube ZOUAK, Dr

    Recruiting

  • Grenoble - CHU

    Grenoble

    Anne-Claire TOFFART, +33 1.56.81.10.45, contact@ifct.fr

    Anne-Claire TOFFART, Pr

    Recruiting

  • La Roche-Sur-Yon - CH

    La Roche-sur-Yon

    Cyril GUIBERT, +33 1.56.81.10.45, contact@ifct.fr

    Cyril GUIBERT, Dr

    Recruiting

  • Le Mans - CHG

    Le Mans

    Dr Camille GUGUEN, +33 1.56.81.10.45, contact@ifct.fr

    Dr Camille GUGUEN, Dr

    Recruiting

  • Lille - CHU

    Lille

    Alexis CORTOT, +33 1.56.81.10.45, contact@ifct.fr

    Alexis CORTOT, Pr

    Recruiting

  • Lyon - CRLCC

    Lyon

    Virginie AVRILLON, +33 1.56.81.10.45, contact@ifct.fr

    Virginie AVRILLON, Dr

    Recruiting

  • Marseille - APHM

    Marseille

    Pascale TOMASINI, +33 1.56.81.10.45, contact@ifct.fr

    Pascale TOMASINI, Dr

    Recruiting

  • Metz - Hôpital Robert Schuman

    Metz

    Benoît GODBERT, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Benoît GODBERT

    Recruiting

  • Montpellier - CHU

    Montpellier

    Benoit ROCH, +33 1.56.81.10.45, contact@ifct.fr

    Benoit ROCH, Dr

    Recruiting

  • Montpellier - ICM

    Montpellier

    Quentin THOMAS, +33 1.56.81.10.45, contact@ifct.fr

    Quentin THOMAS, Dr

    Recruiting

  • Nice - CHU

    Nice

    Jonathan BENZAQUEN, +33 1.56.81.10.45, contact@ifct.fr

    Jonathan BENZAQUEN, Dr

    Recruiting

  • Orléans - CHR

    Orléans

    Hugues MOREL, +33 1.56.81.10.45, contact@ifct.fr

    Hugues MOREL, Dr

    Recruiting

  • Paris - Bichat

    Paris

    Gérard ZALCMAN, +33 1.56.81.10.45, contact@ifct.fr

    Gérard ZALCMAN, Pr

    Recruiting

  • Paris - HEGP

    Paris

    Elizabeth FABRE, +33 1.56.81.10.45, contact@ifct.fr

    Elizabeth FABRE, Dr

    Recruiting

  • Paris - Hôpital Cochin

    Paris

    Marie WISLEZ, +33 1.56.81.10.45, contact@ifct.fr

    Marie WISLEZ, Pr

    Recruiting

  • Paris - Pitié-Salpêtrière

    Paris

    Aurore VOZY, +33 1.56.81.10.45, contact@ifct.fr

    Aurore VOZY, Dr

    Recruiting

  • Paris - Tenon

    Paris

    Pr Jacques CADRANEL, +33 1.56.81.10.45, contact@ifct.fr

    Pr Jacques CADRANEL, Pr

    Recruiting

  • Pau - CHG

    Pau

    Aldo RENAULT, +33 1.56.81.10.45, contact@ifct.fr

    Aldo RENAULT, Dr

    Recruiting

  • Bordeaux - CHU

    Pessac

    Maéva ZYSMAN, +33 1.56.81.10.45, contact@ifct.fr

    Maéva ZYSMAN, Dr

    Recruiting

  • Poitiers - CHU

    Poitiers

    Clotilde DELDYCKE, +33 1.56.81.10.45, contact@ifct.fr

    Clotilde DELDYCKE, Dr

    Recruiting

  • Annecy - CH

    Pringy

    Valérie PAULUS-JACQUEMET, +33 1.56.81.10.45, contact@ifct.fr

    Valérie PAULUS-JACQUEMET, Dr

    Recruiting

  • Rennes - CHU

    Rennes

    Charles RICORDEL, +33 1.56.81.10.45, contact@ifct.fr

    Charles RICORDEL, Dr

    Recruiting

  • Rouen - CHU

    Rouen

    Florian GUISIER, +33 1.56.81.10.45, contact@ifct.fr

    Florian GUISIER, Pr

    Recruiting

  • Strasbourg - NHC

    Strasbourg, 63000

    Céline MASCAUX, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Céline MASCAUX, Pr

    Recruiting

  • Suresnes - Foch

    Suresnes

    Alexandra BIZOT, +33 1.56.81.10.45, contact@ifct.fr

    Alexandra BIZOT, Dr

    Recruiting

  • Toulon - CHI

    Toulon

    Clarisse AUDIGIER-VALETTE, +33 1.56.81.10.45, contact@ifct.fr

    Clarisse AUDIGIER-VALETTE, Dr

    Recruiting

  • Toulouse - CHU

    Toulouse

    Laurence BIGAY-GAME, +33 1.56.81.10.45, contact@ifct.fr

    Laurence BIGAY-GAME, Dr

    Recruiting

  • Tours - CHU

    Tours

    Delphine Carmier, +33 1.56.81.10.45, contact@ifct.fr

    Delphine Carmier, Dr

    Recruiting

Other trials in France

About this study

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.

Being tested
Plasma ctDNA, FFPE blocks
Keywords
IFCT, NSCLC, Adjuvant Osimertinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Plasma ctDNAOther

    • 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

  • FFPE blocksOther

    • Surgery FFPE blocks
    • FFPE blocks at relapse (optional)
Study groups in NCT06053099
Study groupRoleWhat they receive
Plasma ctDNA and FFPE blocksExperimentalNot described
Receives: Other: Plasma ctDNA; Other: FFPE blocks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility study

    Number of patients included receiving osimertinib after 18 months of enrollment

    Measured: 18 months

Secondary outcomes (1)

  1. Incidence, nature, and severity of osimertinib-related adverse events (safety)

    Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).

    Measured: About 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2023
  2. Study start22 Jan 2024
  3. Primary completionOct 2031 (estimated)
  4. Study completionOct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06053099
Sponsor's protocol ID
IFCT-2202
Acronym
ROSIE
Status last verified
Mar 2024
First submitted
18 Aug 2023
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Plasma ctDNA and FFPE blocks in people with Non Small Cell Lung Cancer and EGFR Activating Mutation, run by Intergroupe Francophone de Cancerologie Thoracique at 36 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility study (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06053099.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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