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.
Key facts
- Who runs it
- Bristol-Myers Squibb
- Where
- Taichung, Tainan, and Taipei, TaiwanSee the 4 sitesAlso in 13 other countries, 46 sites
- Trial code
- NCT07871214
- EudraCT 2026-527590-11
- U1111-1343-3078
- 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)
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 80 people, planned
- Starts
- 30 Nov 2026
- Expected to end
- 15 Mar 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- Pumitamig
- Carboplatin
- Cisplatin
- Paclitaxel
- Pemetrexed
- Record updated
- 13 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed lung cancer (non-small cell type) that has not been treated and can be removed by surgery. Treatment is given before the operation.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Non-small cell lung cancer, squamous or non-squamous, that can be removed by surgery, Stage IIA to IIIB (N2)
- Earlier treatment
- Must not have had any earlier cancer drug treatment, radiotherapy or investigational treatment for this lung cancer
- Biomarker or test result
- PD-L1 level must be measurable
Main reasons for not taking part
- Cancer that cannot be removed by surgery, N3 lymph node spread, or spread to distant organs
- Active autoimmune disease
- Serious heart problems
- Serious lung disease, or past or current interstitial lung disease or pneumonitis needing steroid treatment
- High risk of bleeding, or a gut fistula, gut perforation or abscess in the abdomen
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Taiwan
Also in 13 other countries, 46 sites
- TaichungHospital not named in the registryContact: Site 0012No longer taking part
- TainanHospital not named in the registryContact: Site 0017No longer taking part
- TaipeiHospital not named in the registryContact: Site 0011No longer taking part
- TaipeiHospital not named in the registryContact: Site 0216No longer taking part
About the trial
What the trial wants to find out
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
The 2 groups in the trial
- Cohort A: PumitamigTreatment being tested
Treatment: Pumitamig, Carboplatin, Cisplatin, Paclitaxel, and Pemetrexed
- Cohort B: PumitamigTreatment being tested
Treatment: Pumitamig, Carboplatin, Cisplatin, Paclitaxel, and Pemetrexed
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests pumitamig before surgery for early-stage lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 October 2026