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Brief Title: 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)
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)
Study ID: NCT05925530
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.
Detailed Description: This will be a multicentre, Phase II, single-arm, global study assessing the efficacy and safety of neoadjuvant durvalumab and platinum-based CT, given intravenously, followed by either surgery and adjuvant durvalumab or definitive CRT and consolidation durvalumab in participants with resectable and borderline resectable stage IIB-IIIB NSCLC. Neoadjuvant Period A: All participants will initially receive 2 cycles of neoadjuvant durvalumab + CT (investigator's choice platinum-based) every three weeks. Participants will be assessed for resectability by a multidisciplinary team. Neoadjuvant Period B: Cohort 1: Participants who are deemed eligible for surgery will receive study intervention every three weeks for an additional one and up to two cycles, followed by surgery. CRT: Cohort 2: Participants with unresectable tumours (according to MDT re-assessment) will receive definitive CRT (6 one-week cycles) for approximately six weeks. Both cohorts will then go on to receive durvalumab every four weeks until disease progression or recurrence or up to one year.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Saint Petersburg, Florida, United States
Research Site, Chicago, Illinois, United States
Research Site, Charlottesville, Virginia, United States
Research Site, Klagenfurt, , Austria
Research Site, Wien, , Austria
Research Site, Wien, , Austria
Research Site, Kelowna, British Columbia, Canada
Research Site, Kingston, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Brno, , Czechia
Research Site, Olomouc, , Czechia
Research Site, Prague, , Czechia
Research Site, Praha 5, , Czechia
Research Site, Brest Cedex, , France
Research Site, La Tronche, , France
Research Site, Marseille, , France
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Research Site, Paris Cedex 5, , France
Research Site, Poitiers, , France
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Research Site, Berlin, , Germany
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Research Site, Gauting, , Germany
Research Site, Grosshansdorf, , Germany
Research Site, Köln, , Germany
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Research Site, Moers, , Germany
Research Site, München, , Germany
Research Site, Offenbach am Main, , Germany
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Research Site, Bari, , Italy
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Research Site, L'Hospitalet de Llobregat, , Spain
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Research Site, Lund, , Sweden