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Clinical Trials in the USA / NCT05925530
Active, not recruiting Phase 2

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)

NCT05925530 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2024-02-22
Last updated
2026-09-09

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Durvalumab →

Durvalumab: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
Research Site The Bronx New York
Research Site Houston Texas
Research Site Charlottesville Virginia
Research Site Vienna Austria
Research Site Vienna Austria
Research Site Kingston Ontario
Research Site Chicoutimi Quebec
Research Site Montreal Quebec
Research Site Brno Czechia
Research Site Olomouc Czechia
Research Site Prague Czechia
Research Site Prague Czechia
Research Site La Tronche France
Research Site Marseille France
Research Site Montpellier France
Research Site Mulhouse France
Research Site Paris France
Research Site Pessac France
Research Site Poitiers France
Research Site Toulouse France
Research Site Berlin Germany
Research Site Cologne Germany
Research Site Großhansdorf Germany
Research Site Moers Germany
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

+ 9 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

More AstraZeneca trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05925530 on ClinicalTrials.gov ↗ ← All trials in the USA