Informations générales (source: ClinicalTrials.gov)
A Multicentre, Phase II, Single-Arm, Interventional Study of Neoadjuvant Durvalumab and Platinum-based Chemotherapy (CT), Followed by Either Surgery and Adjuvant Durvalumab or Chemoradiotherapy (CRT) and Consolidation Durvalumab, in Participants With Resectable or Borderline Resectable Stage IIB-IIIB Non-small Cell Lung Cancer (NSCLC) (MDT-BRIDGE)
Interventional
Phase 2
AstraZeneca (Voir sur ClinicalTrials)
février 2024
août 2027
24 septembre 2024
The purpose of this study is to assess efficacy and safety of neoadjuvant durvalumab in
combination with platinum-based chemotherapy (CT) given as initial therapy after cancer
diagnosis followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT)
and consolidation durvalumab given alone as further therapy in participants with
resectable and borderline resectable stage IIB-IIIB NSCLC.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:40 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 13008 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 29200 - Brest Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 38700 - La Tronche - France | Contact (sur clinicalTrials) | ||||
| Research Site - 68070 - Mulhouse - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75005 - Paris Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Research Site - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Deemed resectable or borderline resectable at baseline, confirmed by MDT evaluation
at diagnosis.
- Previously untreated and pathologically confirmed Stage IIB to select [i.e.N2] Stage
IIIB by AJCC v8.
- Nodal status confirmed with whole body FDG-PET and biopsy via endobronchial
ultrasound, mediastinoscopy, or thoracoscopy.
- Mandatory brain MRI.
- EGFR and ALK wild-type.
- Medically operable: adequate cardiac and lung function to undergo resection.
- Participant must be ≥ 18 years, at the time of screening.
- Histologically or cytologically documented NSCLC.
- Minimum life expectancy of 12 weeks.
- Minimum body weight of 30 kg.
- Male and female participants must be willing to use acceptable methods of
contraception.
- Female participants of childbearing potential must have negative pregnancy test.
- Deemed resectable or borderline resectable at baseline, confirmed by MDT evaluation
at diagnosis.
- Previously untreated and pathologically confirmed Stage IIB to select [i.e.N2] Stage
IIIB by AJCC v8.
- Nodal status confirmed with whole body FDG-PET and biopsy via endobronchial
ultrasound, mediastinoscopy, or thoracoscopy.
- Mandatory brain MRI.
- EGFR and ALK wild-type.
- Medically operable: adequate cardiac and lung function to undergo resection.
- Participant must be ≥ 18 years, at the time of screening.
- Histologically or cytologically documented NSCLC.
- Minimum life expectancy of 12 weeks.
- Minimum body weight of 30 kg.
- Male and female participants must be willing to use acceptable methods of
contraception.
- Female participants of childbearing potential must have negative pregnancy test.
- Unresectable NSCLC confirmed by MDT evaluation at baseline
- Stage IIIC patients
- Participants whose planned surgery at enrollment is a wedge resection
- Known EGFR mutation or ALK translocation
- Participants contraindicated for surgical intervention due to comorbid conditions
- Participants who are allergic to study intervention.
- Participants with more than one primary tumour.
- Known active hepatitis infection, positive HCV antibody, HBsAg or HBV core antibody
(anti-HBc), at screening.
- Female participants who are pregnant or breastfeeding.
- Judgement by the investigator that the participant should not participate in the
study.
- Previously infected or tested positive for human immunodeficiency virus.