General information
  • Disease category Lung Cancer (BASEC)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Basel, Bellinzona, St. Gallen, Other
    (BASEC)
  • Contact Prof. Markus Jörger markus.joerger@h-och.ch (BASEC)
  • Data Source(s) BASEC: Import from 13.05.2026 ICTRP: N/A
  • Last update 13.05.2026 10:25
HumRes68062 | SNCTP000006868 | BASEC2026-00208

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)

  • Disease category Lung Cancer (BASEC)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Basel, Bellinzona, St. Gallen, Other
    (BASEC)
  • Contact Prof. Markus Jörger markus.joerger@h-och.ch (BASEC)
  • Data Source(s) BASEC: Import from 13.05.2026 ICTRP: N/A
  • Last update 13.05.2026 10:25

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)

Criteria for participation in trial
- 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)

not available

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@h-och.ch

HOCH 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