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Looking for participantsPhase3

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)

Sponsor: Bristol-Myers Squibb

NCT ID: NCT07361510

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pumitamig (drug), Pembrolizumab (drug)
How long the study runs
Study runs about 67 months (dates as stated)
About the drug or intervention
Pumitamig — drug: Specified dose on specified days · Pembrolizumab — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
750
Started
2026-03-12
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for non-small cell lung cancer (nsclc)
  • • Phase3 - 750 participants
  • • 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%

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-small cell lung cancer (nsclc)

Where?

  • • Aberdeen - Aberdeen Royal Infirmary
  • • Middlesbrough - Local Institution - 0112
  • • Norwich - Norfolk and Norwich University Hospital
  • • Sutton - The Royal Marsden NHS Foundation Trust
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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%.

Non-Small Cell Lung Cancer (NSCLC)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PD-L1

Treatment history

Treatments you must have had:

  • ✓ a programmed death ligand-1 (PD-L1) expression ≥ 50%
  • ✓ measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1
  • ✓ no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC
  • ✓ an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Participants must have a confirmed by testing a sample diagnosis of Non-Small Cell Lung Cancer (NSCLC)...
  • ✓Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%.
  • ✓Participants must have cancer that can be measured on scans as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • ✓Participants must have no prior systemic anti-tumor therapy for that has grown locally or that has spread NSCLC.
See the full criteria
Inclusion Criteria * 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 Criteria * Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated. * Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression. * 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. * Other protocol-defined Inclusion/Exclusion criteria apply.

Where Is This Study? (9 UK sites)

Aberdeen Royal Infirmary

Aberdeen AB25 2ZN, United Kingdom

Recruiting
Site contact (verified)
Andrew Duncan, Site 036501224 550072

Local Institution - 0112

Middlesbrough TS4 3BW, United Kingdom

WITHDRAWN

Norfolk and Norwich University Hospital

Norwich NR47UY, United Kingdom

Recruiting
Site contact (verified)
Farasat Kazmi, Site 042601603 286286

The Royal Marsden NHS Foundation Trust

Sutton SM25PT, United Kingdom

Recruiting
Site contact (verified)
Sanjaykumar Popat, Site 04100208 186 5267

Addenbrooke's Hospital

Cambridge CB2 2QQ, United Kingdom

Recruiting
Site contact (verified)
Huiqi Yang, Site 011401223 216083

Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

Recruiting
Site contact (verified)
paul shaw, Site 018202920 615888

The Royal Surrey County Hospital NHS Foundation Trust

Guildford GU2 7XX, United Kingdom

Recruiting
Site contact (verified)
Ajay Mehta, Site 000701483 571122 EX 2627

Royal Marsden Hospital (Chelsea)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Sanjaykumar Popat, Site 008700442078082132

Royal Wolverhampton Nhs Trust

Wolverhampton WV10 0QP, United Kingdom

Recruiting
Site contact (verified)
Talha Hafeez, Site 037101902 307999

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09