MDT-BRIDGE - 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) - D9106C00002

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- 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.

Schema di trattamento: 

Participants that go on to receive surgery, will receive durvalumab for up to four cycles prior to surgery. Participants that go on to receive CRT will receive durvalumab for up to two cycles prior to CRT. All participants will receive durvalumab every four weeks until disease progression or recurrence or up to 12 months following surgery/CRT, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

Trattamento sperimentale: 

Durvalumab

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

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.

Note generali: 

NB: Oltre che nei Centri sotto elencati, lo studio è previsto anche nelle seguenti città:

- Bari (70124)
- Napoli (80131)
- Palermo (90127)
- Pavia (27100)

Centri partecipanti

Nord Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT05925530

Data di inserimento: 15.12.2023

Promotore

AstraZeneca

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd