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Spots Global Cancer Trial Database for 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)

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Trial Identification

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

Interventions

Durvalumab

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Research Site, Montpellier, , France

Research Site, Paris Cedex 5, , France

Research Site, Poitiers, , France

Research Site, Rouen, , France

Research Site, Toulouse, , France

Research Site, Vesoul, , France

Research Site, Berlin, , Germany

Research Site, Berlin, , Germany

Research Site, Esslingen, , Germany

Research Site, Gauting, , Germany

Research Site, Grosshansdorf, , Germany

Research Site, Köln, , Germany

Research Site, Luebeck, , Germany

Research Site, Moers, , Germany

Research Site, München, , Germany

Research Site, Offenbach am Main, , Germany

Research Site, Wuerzburg, , Germany

Research Site, Törökbálint, , Hungary

Research Site, Bari, , Italy

Research Site, Bologna, , Italy

Research Site, Milano, , Italy

Research Site, Milan, , Italy

Research Site, Napoli, , Italy

Research Site, Palermo, , Italy

Research Site, Pavia, , Italy

Research Site, Peschiera Del Garda, , Italy

Research Site, Treviso, , Italy

Research Site, Lisboa, , Portugal

Research Site, Lisboa, , Portugal

Research Site, Vila Nova De Gaia, , 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, Valencia, , Spain

Research Site, Zaragoza, , Spain

Research Site, Lund, , Sweden

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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