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)
MDT-BRIDGE
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)
2 other identifiers
interventional
142
11 countries
49
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Feb 2024
Typical duration for phase_2 nonsmall-cell-lung-cancer
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedStudy Start
First participant enrolled
February 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2027
ExpectedApril 16, 2026
April 1, 2026
1.9 years
June 22, 2023
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resection rate
Resection rate is defined as the proportion of all participants who underwent definitive surgery. Participants who undergo (ie, start) surgery with the goal of complete tumour resection will be counted as meeting this endpoint.
At day of surgery (Within 40 days of the last dose of neoadjuvant treatment)
Secondary Outcomes (23)
Resection rate
At the day of surgery (within 40 days after the last dose of neoadjuvant treatment)
R0, R1, R2 resection rates
At the day of surgery (within 40 days after the last dose of neoadjuvant treatment)
Pathological complete response (pCR)
At the day of surgery (within 40 days after the last dose of neoadjuvant treatment)
Overall Survival (OS)
From first dose of study intervention until death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Overall Survival (OS) rate
At 12 months and 24 months
- +18 more secondary outcomes
Study Arms (1)
Durvalumab
EXPERIMENTALDurvalumab will be administered to the participants via intravenous infusion (IV)
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (49)
Research Site
The Bronx, New York, 10467, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Charlottesville, Virginia, 22908, United States
Research Site
Vienna, 1130, Austria
Research Site
Vienna, 1140, Austria
Research Site
Kingston, Ontario, K7L 2V7, Canada
Research Site
Chicoutimi, Quebec, G7H 5H6, Canada
Research Site
Montreal, Quebec, H4A 3J1, Canada
Research Site
Brno, 625 00, Czechia
Research Site
Olomouc, 77900, Czechia
Research Site
Prague, 12808, Czechia
Research Site
Prague, 150 06, Czechia
Research Site
La Tronche, 38700, France
Research Site
Marseille, 13008, France
Research Site
Montpellier, 34295, France
Research Site
Mulhouse, 68070, France
Research Site
Paris, 75005, France
Research Site
Pessac, 33604, France
Research Site
Poitiers, 86000, France
Research Site
Toulouse, 31059, France
Research Site
Berlin, 13125, Germany
Research Site
Cologne, 51109, Germany
Research Site
Großhansdorf, 22927, Germany
Research Site
Moers, 47441, Germany
Research Site
Würzburg, 97074, Germany
Research Site
Budapest, 1122, Hungary
Research Site
Törökbálint, 2045, Hungary
Research Site
Bari, 70124, Italy
Research Site
Bologna, 40138, Italy
Research Site
Milan, 20132, Italy
Research Site
Milan, 20133, Italy
Research Site
Milan, 20141, Italy
Research Site
Naples, 80131, Italy
Research Site
Palermo, 90127, Italy
Research Site
Pavia, 27100, Italy
Research Site
Peschiera del Garda, 37019, Italy
Research Site
Lisbon, 1350-352, Portugal
Research Site
Lisbon, 1500-650, Portugal
Research Site
Barakaldo, 48903, Spain
Research Site
Barcelona, 08025, Spain
Research Site
L'Hospitalet de Llobregat, 08908, Spain
Research Site
Madrid, 28007, Spain
Research Site
Madrid, 28027, Spain
Research Site
Madrid, 28046, Spain
Research Site
Pamplona, 31008, Spain
Research Site
Valencia, 46009, Spain
Research Site
Zaragoza, 50009, Spain
Research Site
Solna, 171 64, Sweden
Research Site
Uppsala, SE-751 85, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2023
First Posted
June 29, 2023
Study Start
February 22, 2024
Primary Completion
January 12, 2026
Study Completion (Estimated)
August 27, 2027
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies-sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.