NCT07871214Not yet recruitingPhase 2
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)
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 7 Oct 2026
- Start date
- 30 Nov 2026
- Primary completion date
- 15 Mar 2028
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Lung cancer
- NCT number
- NCT07871214
- EudraCT number
- 2026-527590-11
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 30 Nov 2026 to the primary completion date, 15 Mar 2028
- 50 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.