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Taking people in TaiwanPhase 3

Compares pumitamig with pembrolizumab for untreated advanced lung cancer

Tests pumitamig against pembrolizumab in adults with advanced non-small cell lung cancer.

Key facts

Who runs it
Bristol-Myers Squibb
Where
Kaohsiung City, Kaohsiung Niao Sung Dist, New Taipei City, Taichung, and Taoyuan, TaiwanSee the 5 sitesAlso in 35 other countries, 268 sites
Trial code
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)
Status
Recruiting
Phase
Phase 3
People taking part
750 people, planned
Started
12 Mar 2026
Expected to end
14 Oct 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Pumitamig
  • Pembrolizumab
Record updated
23 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 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

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Taiwan

Also in 35 other countries, 268 sites

  • E-DA HospitalKaohsiung City, TaiwanContact: Yu-Feng Wei, Site 0387Taking people
  • Chang Gung Memorial Hospital at KaohsiungKaohsiung Niao Sung Dist, TaiwanContact: Kuo-Tung Huang, Site 0389Taking people
  • Far Eastern Memorial HospitalNew Taipei City, TaiwanContact: Cheng-Yu Chang, Site 0035Taking people
  • Taichung Veterans General HospitalTaichung, TaiwanContact: Tsung-Ying Yang, Site 0203Taking people
  • Chang Gung Medical Foundation-Linkou BranchTaoyuan, TaiwanContact: Cheng-Ta Yang, Site 0388Taking people

About the trial

What the trial wants to find out

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%.

The 2 groups in the trial

  • Arm A: PumitamigTreatment being tested

    Treatment: Pumitamig

  • Arm B: PembrolizumabExisting treatment, for comparison

    Treatment: Pembrolizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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%.
Plain-language title
Compares pumitamig with pembrolizumab for untreated advanced 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 13 November 2026.
Fit questions
Built from NCT07361510, who can take part
Record updated
23 October 2026