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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)
Sponsor: AstraZeneca
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2024-02-22
Completion Date
2027-08-27
Last Updated
2026-01-29
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (49)
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The Bronx, New York, United States
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Houston, Texas, United States
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Charlottesville, Virginia, United States
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Vienna, Austria
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Vienna, Austria
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Kingston, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Montreal, Quebec, Canada
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Brno, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Prague, Czechia
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La Tronche, France
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Marseille, France
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Montpellier, France
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Mulhouse, France
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Paris, France
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Pessac, France
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Poitiers, France
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Toulouse, France
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Berlin, Germany
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Cologne, Germany
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Großhansdorf, Germany
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Moers, Germany
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Würzburg, Germany
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Budapest, Hungary
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Törökbálint, Hungary
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Bari, Italy
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Bologna, Italy
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Milan, Italy
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Milan, Italy
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Milan, Italy
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Naples, Italy
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Palermo, Italy
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Pavia, Italy
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Peschiera del Garda, Italy
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Lisbon, Portugal
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Lisbon, Portugal
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Barakaldo, Spain
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Barcelona, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Pamplona, Spain
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Valencia, Spain
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Zaragoza, Spain
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Solna, Sweden
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Uppsala, Sweden