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
- Bangkok, Chiang Mai, Khon Kaen, and Songkhla, ThailandSee the 4 sites
- Phase
- Phase 3
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 Thailand
- BangkokBangkok, ThailandNot yet recruiting
- Chiang MaiChiang Mai, ThailandNot yet recruiting
- Khon KaenKhon Kaen, ThailandNot yet recruiting
- SongkhlaSongkhla, ThailandNot yet recruiting
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.