Phase
Condition
N/ATreatment
FFPE blocks
Plasma ctDNA
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed Informed consent.
- Age ≥ 18 years.
- Pre-surgical disease evaluation including brain MRI/CT-scan and total body PET-FDGCT-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 molecularanalyses.
- Patient eligible to receive osimertinib adjuvant therapy in a 3-year intent to treatdecision; patients could receive if necessary adjuvant chemotherapy before startingosimertinib treatment.
- Patient who is capable, according to the investigator, of complying with the study'srequirements and restrictions.
- Patient followed in the institution on a regular basis (every 3 to 6 months) accordingto 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 courseof 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 areeligible if an efficacious contraception method should be used during the treatmentand during the 4 months following the last dose.
Exclusion
Exclusion Criteria:
- 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.
- Neoadjuvant anti-cancer treatment (osimertinib and/or chemotherapy or otheranti-cancer treatment).
- Incompletely resected NSCLC (R1 or R2).
- Any medical condition that would, according to the investigator's judgment, preventthe patient's participation in the clinical study.
- 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
Connect with a study center
Angers - CHU
Angers,
FranceActive - Recruiting
Bayonne - CH
Bayonne,
FranceActive - Recruiting
Boulogne - Ambroise Paré
Boulogne,
FranceActive - Recruiting
Lyon - URCOT
Bron,
FranceActive - Recruiting
Caen - CHU
Caen,
FranceActive - Recruiting
Clermont-Ferrand - CHU
Clermont-Ferrand,
FranceActive - Recruiting
Colmar - CH
Colmar,
FranceActive - Recruiting
Créteil - CHI
Créteil,
FranceActive - Recruiting
Dijon - CHU Bocage
Dijon,
FranceActive - Recruiting
Grenoble - CHU
Grenoble,
FranceActive - Recruiting
La Roche-Sur-Yon - CH
La Roche-sur-Yon,
FranceActive - Recruiting
Le Mans - CHG
Le Mans,
FranceActive - Recruiting
Lille - CHU
Lille,
FranceActive - Recruiting
Lyon - CRLCC
Lyon,
FranceActive - Recruiting
Marseille - APHM
Marseille,
FranceActive - Recruiting
Metz - Hôpital Robert Schuman
Metz,
FranceActive - Recruiting
Montpellier - CHU
Montpellier,
FranceActive - Recruiting
Montpellier - ICM
Montpellier,
FranceActive - Recruiting
Nice - CHU
Nice,
FranceActive - Recruiting
Orléans - CHR
Orléans,
FranceActive - Recruiting
Paris - Bichat
Paris,
FranceActive - Recruiting
Paris - HEGP
Paris,
FranceActive - Recruiting
Paris - Hôpital Cochin
Paris,
FranceActive - Recruiting
Paris - Pitié-Salpêtrière
Paris,
FranceActive - Recruiting
Paris - Tenon
Paris,
FranceActive - Recruiting
Pau - CHG
Pau,
FranceActive - Recruiting
Bordeaux - CHU
Pessac,
FranceActive - Recruiting
Poitiers - CHU
Poitiers,
FranceActive - Recruiting
Annecy - CH
Pringy,
FranceActive - Recruiting
Rennes - CHU
Rennes,
FranceActive - Recruiting
Rouen - CHU
Rouen,
FranceActive - Recruiting
Strasbourg - NHC
Strasbourg, 63000
FranceActive - Recruiting
Suresnes - Foch
Suresnes,
FranceActive - Recruiting
Toulon - CHI
Toulon,
FranceActive - Recruiting
Toulouse - CHU
Toulouse,
FranceActive - Recruiting
Tours - CHU
Tours,
FranceActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.