A study of Pumitamig compared to Durvalumab after concurrent chemoradiotherapy in participants with unresectable stage III non-small cell lung cancer (NSCLC) (ROSETTA Lung-201)
Descrizione riassuntiva dello studio
A study of Pumitamig compared to Durvalumab after concurrent chemoradiotherapy in participants with unresectable stage III non-small cell lung cancer (NSCLC)
(BASEC)
Intervento studiato
Experimental: Arm A:
Drug: Pumitamig
Specified dose on certain days
Other name: BMS-986545
Active comparator: Arm B:
Drug: Durvalumab
Specified dose on certain days
(BASEC)
Malattie studiate
Non-small cell lung cancer (NSCLC)
(BASEC)
- Participants must have a histologically or cytologically confirmed diagnosis of unresectable stage III non-small cell lung cancer (NSCLC) - Participants must have received at least 2 cycles of platinum-based concurrent chemotherapy (a total radiation dose of at least 54 Gy). - Participants must not have disease progression (PD) after treatment with concurrent chemoradiotherapy (CCRT). - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. (BASEC)
Criteri di esclusione
- Participants with non-squamous histology must not have documented epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements. - Participants must not have an active autoimmune disease. - Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary artery disease (within 6 months prior to randomization), ventricular arrhythmias, severe thrombotic or embolic events or severe hemorrhagic events within 6 months prior to randomization or significant risk of pulmonary hemorrhage. - Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or a history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ grade 2), or current or suspected ILD or pneumonitis. - Participants must not have received prior cancer therapy (other than CCRT) for locally advanced stage III disease. - Additional inclusion/exclusion criteria defined in the study protocol apply. (BASEC)
Luogo dello studio
Basilea, Bellinzona, San Gallo, Altro
(BASEC)
Münsterlingen (Thurgau)
(BASEC)
Sponsor
Bristol-Myers Squibb Services Unlimited Company Plaza 254 Blanchardstown Corporate Park 2 Ballycoolin Dublin 15 D15 T867 Ireland
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Markus Jörger
41 (0)76 559 10 70
markus.joerger@clutterh-och.chHOCH Health Ostschweiz (Kantonsspital St. Gallen) Klinik für Medizinische Onkologie und Hämatologie Rorschacher Strasse 95 9007 St. Gallen
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Ethikkommission Ostschweiz EKOS
(BASEC)
Data di approvazione del comitato etico
09.04.2026
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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