Etude : PACIFIC-R / D4194R00005

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : PACIFIC-R / D4194R00005

Situation thérapeutique :

Traitement :

Cadre réglementaire : RIPH3

Dernière MÀJ : 22/06/2021
CIM10 - Localisation(s)
Informations principales
Titre : First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Informations complémentaires
Schéma : This is a non-interventional/observational study including NSCLC unresectable Stage III patients treated with durvalumab. Patient selection and retrospective data collection will be from participating countries: Australia, Belgium, Israel, Netherlands, Norway France, Germany, Italy, Switzerland, Spain
Data will be collected from those patients who have received at least one dose of durvalumab between September 2017 through 21 DEC 2018. Patients may participate in other clinical trials during this follow-up period.

Patients must have completed a platinum-based chemotherapy concurrently or sequentially with radiation therapy without evidence of disease progression. There is no fixed maximum duration for durvalumab treatment and it continues until the physician determines that it is in the patient's best interest to stop therapy.

Chart abstractions will occur at specified intervals up to five years after the patient had the first dose of durvalumab. A target of four (maximum five) chart extractions is anticipated for each participant. Dates may be adjusted based on local market ethics processes or patient enrolment.
- First chart extraction will be used to determine which patients meet the inclusion/exclusion criteria for the study and will retrospectively collect all data from diagnosis of stage III unresectable NSCLC and the durvalumab start date (index date).
- The second chart extraction will be triggered at time of estimated maturity of PFS data to provide an accurate measure of the PFS outcome.
- The third chart extraction will be triggered at time of estimated maturity of OS data to provide an accurate measure of the OS outcome• The fourth and fifth chart extractions will occur approximately 3-years and 5-years after enrolment
- The dates for the second through fifth chart abstractions may be adjusted, pending data availability. The estimated PFS and OS maturity will be calculated from the actual patient index dates (date of first dose of durvalumab) and any available data on PFS and OS observed in the first extraction together with the distribution of PFS and OS observed in the PACIFIC trial.

Phase : IV

Stade : Localement avancé

Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures
- Age ≥ 18 years at time of study entry or adult according to each country regulations for age of majority
- Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 7 or 8)
- Patients must have been enrolled in one of the durvalumab EAPs Patients must have been treated with at least one dose of durvalumab within the EAP prior to the study entry and between start of EAP in the country, from September 2017 or later up to end of EAP enrolment or MA + three months (estimated as maximum to 30 December 2018) (whichever occurs earlier).

Patients who die during the EAP are eligible to enter in the study when local laws allow for a consent waiver, if all other inclusion/exclusion criteria are met.

Critères de non-inclusion : Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).
Informations relatives au promoteur
Promoteur :
Type de sponsor : Industriel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Alexis Cortot

Eric Wasielewski

Statut de l'essai : CLOS

MAJ : 06/10/2020

Centre investigateur :
Centre Hospitalier de Béthune - 27 rue Delbecque - CS 10809 - 62400 BETHUNE

Investigateur :
Docteur Quentin BURY

Claire MAZUY
06 27 19 41 05

Statut de l'essai : CLOS

MAJ : 21/10/2020