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A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)

StatusRecruiting
PhasePhase 3
Started2026-03-16
View on ClinicalTrials.gov ↗

Amendment history

2026-09-04
Study Status, Contacts/Locations v11
Study sites258→259
2026-08-07
Study Status, Contacts/Locations v10
Study sites256→258
2026-07-17
Study Status, Contacts/Locations v9
Study sites255→256
2026-06-25
Study Status, Contacts/Locations v8
Study sites255 entries, revised
LocalTennessee InstitutionOncology The University of Texas-MD Anderson Cancer Center Instituto de Investigaciones Clínicas Córdoba S.A. Nepean Hospital St. Marys Hospital Center Fujian Cancer Hospital Qilu Hospital of Shandong University Shandong Cancer Hospital Institut Bergonié - 0480Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest LocalHôpital InstitutionNord Guillaume-et-René-Laennec / CHU de Nantes Hopitaux Universitaires Paris Centre-Hopital Cochin Universitaetsklinikum Jena Krankenhaus Martha-Maria Halle-Doelau Ggmbh LungenClinic Grosshansdorf GmbH Lungenfachklinik Imm [...] [...]
2026-06-02
Study Status, Contacts/Locations v7
Study sites254→255
Show 6 earlier versions
2026-05-13
Study Status, Contacts/Locations v6
Study sites254 entries, revised
LocalLyell InstitutionMcEwin Hospital Joondalup Health Campus Asan Medical Center Samsung Medical Center Kantonsspital Münsterlingen - 0448Spital Thurgau AG LocalClatterbridge InstitutionCancer Centre - 0476 Local Institution - 0035 Local Institution - 0064 Local Institution - 0738 Local Institution - 0232Liverpool
2026-04-29
Study Status, Contacts/Locations v5
Study sites255→254
2026-04-03
Study Status, Contacts/Locations v4
Study sites256→255
2026-03-24
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-04-09→confirmed 2026-03-16
Study sites255→256
Eligibility criteria+5 characters
[...] ave received at least 2 cycles of platinum-based concurrent chemotherapychemoradiotherapy (a total dose of radiation of at least 54 Gy). Participants [...]
2026-02-17
Study Status, Contacts/Locations, IPDSharing v2
Study sites249→255
2026-01-27
Study Status, Conditions, Contacts/Locations, References v1
Study sites239→249
2026-01-21
Original filing
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Trial Details
NCT Number NCT07361497
Lead Sponsor Bristol-Myers Squibb
Collaborators: BioNTech SE
Conditions Non-small Cell Lung Cancer (NSCLC)
Enrollment 850 participants
Start Date 2026-03-16
Primary Completion 2030-09-18 (estimated)
Study Completion 2034-01-13 (estimated)
Updated on ClinicalTrials.gov 2026-09-30