Compares pumitamig with pembrolizumab for untreated advanced lung cancer
Tests pumitamig against pembrolizumab in adults with advanced non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)
Key facts
- Where
- 'S-Hertogenbosch, Amersfoort, Nijmegen, and Tilburg, NetherlandsSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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 advanced non-small cell lung cancer who have not had treatment for it yet and whose tumour has high PD-L1 (50% or more).
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Non-small cell lung cancer (squamous or nonsquamous), Stage IIIB/IIIC or Stage IV, with measurable disease (RECIST v1.1) and ECOG Performance Status 0-1
- Earlier treatment
- No earlier systemic anti-tumor therapy for locally advanced or metastatic non-small cell lung cancer
- Biomarker or test result
- PD-L1 expression of 50% or more
Main reasons for not taking part
- A documented actionable genomic alteration for which approved first-line therapies are indicated
- Symptomatic untreated brain or spinal cord spread (CNS metastases, leptomeningeal metastases, spinal cord compression)
- Significant heart or blood vessel problems, such as uncontrolled high blood pressure or heart failure
- Active autoimmune disease
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- What was the PD-L1 result of your tumour test?
- Can you look after yourself and are you up and about most of the day?
- Has your cancer spread to the brain?
Source: NCT07361510, who can take part
Where in Netherlands
- Jeroen Bosch Ziekenhuis Stichting'S-Hertogenbosch, NetherlandsTaking people
- Meander Medisch CentrumAmersfoort, NetherlandsTaking people
- Radboud universitair medisch centrum StichtingNijmegen, NetherlandsTaking people
- Elisabeth-Tweesteden ZiekenhuisTilburg, NetherlandsTaking people
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
- NCT07361510EU 2025-523586-18-00
- Record updated
- 23 October 2026
- Original description
The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.Read full original descriptionShow less
ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.
The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.
Inclusion: Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease; Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%; Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC; Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Exclusion: Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated; Participants must not have any 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 or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage; Participants must not an active autoimmune disease; Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression; Other protocol-defined Inclusion/Exclusion criteria apply.