Tests pumitamig before surgery for early-stage lung cancer
Tests pumitamig-based treatment before surgery in adults with early-stage non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A Study to Assess The Safety and Tolerability of Pumitamig-Based Therapy Administered Before Surgery in Participants With Early-Stage Non-Small Cell Lung Cancer (ROSETTA Lung-220)
Key facts
- Where
- Bucharest, Cluj-Napoca, and Iași, RomaniaSee the 4 sites
- Phase
- Phase 2
Where in Romania
- BucharestBucharest, RomaniaNo longer taking part
- BucharestBucharest, RomaniaNo longer taking part
- Cluj-NapocaCluj-Napoca, RomaniaNo longer taking part
- IașiIași, RomaniaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07871214
- Record updated
- 13 October 2026
- Original description
The purpose of this study is to assess the safety, tolerability, and surgical feasibility of preoperative Pumitamig-based therapy and other molecules in resectable, Early-Stage Non-Small Cell Lung CancerRead full original descriptionShow less
ROSETTA Lung-220: A Phase 2, Open-Label, Multicenter, Multi-Arm Platform Study Evaluating Pumitamig and Other Novel Neoadjuvant Regimens in Participants With Resectable, Early-Stage (IIA to IIIB) Non-Small Cell Lung Cancer
The purpose of this study is to assess the safety, tolerability, and surgical feasibility of preoperative Pumitamig-based therapy and other molecules in resectable, Early-Stage Non-Small Cell Lung Cancer
Inclusion: Participants must have newly diagnosed, previously untreated participants with histologically confirmed non-small cell lung cancer (NSCLC) (squamous or non-squamous histology); resectable Stage IIA to IIIB (N2) disease (American Joint Committee on Cancer (AJCC) 9th edition); Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Participants must have an evaluable programmed death-ligand 1 (PD-L1) expression.
Exclusion: Participants must not have significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias or major thrombotic or embolic events; Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or who have current or suspected ILD or pneumonitis; Participants must not have prior systemic anticancer therapy, radiotherapy, or investigational therapy for NSCLC or contraindication to curative-intent surgery or study-specified chemotherapy; Participants must not have unresectable disease, N3 nodal involvement, or any evidence of distant metastatic disease (M1) at baseline assessment (suspected or confirmed); Participants must not have active, known autoimmune disease; Participants must not have significant risk of bleeding or history of major hemorrhagic events (including gastrointestinal (GI) hemorrhage or hemorrhagic stroke); Participants must not have GI or non-GI fistula, GI perforation, or intra-abdominal abscess; Other protocol-defined Inclusion/Exclusion criteria apply.