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)
Summary description of the study
A study of Pumitamig compared to Durvalumab after concurrent chemoradiotherapy in participants with unresectable stage III non-small cell lung cancer (NSCLC)
(BASEC)
Intervention under investigation
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)
Disease under investigation
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)
Exclusion criteria
- 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)
Trial sites
Basel, Bellinzona, St. Gallen, Other
(BASEC)
Münsterlingen (Thurgau)
(BASEC)
Sponsor
Bristol-Myers Squibb Services Unlimited Company Plaza 254 Blanchardstown Corporate Park 2 Ballycoolin Dublin 15 D15 T867 Ireland
(BASEC)
Contact
Contact Person Switzerland
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)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
09.04.2026
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available