Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE)

Running, not enrolling · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID: NCT05925530
Run by: AstraZeneca
People needed: 142
Starts: 2024-02-22
Expected to finish: 2027-08-27
Last updated by the study team: 2026-06-30

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Research Site — Würzburg, Germany
Research Site — Budapest, Hungary
Research Site — Törökbálint, Hungary
Research Site — Bari, Italy
Research Site — Bologna, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
Research Site — Naples, Italy
Research Site — Palermo, Italy
Research Site — Pavia, Italy
Research Site — Peschiera del Garda, Italy
Research Site — Lisbon, Portugal
Research Site — Lisbon, Portugal
Research Site — Barakaldo, Spain
Research Site — Barcelona, Spain
Research Site — L'Hospitalet de Llobregat, Spain
Research Site — Madrid, Spain
Research Site — Madrid, Spain
Research Site — Madrid, Spain
Research Site — Pamplona, Spain
Research Site — Valencia, Spain
Research Site — Zaragoza, Spain
Research Site — Solna, Sweden
Research Site — Uppsala, Sweden

Full record on ClinicalTrials.gov

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