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Looking for participantsPhase3

A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)

Sponsor: Bristol-Myers Squibb

NCT ID: NCT07361497

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), Durvalumab (drug)
How long the study runs
Study runs about 94 months (dates as stated)
About the drug or intervention
Pumitamig — drug: Specified dose on specified days · Durvalumab — 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
850
Started
2026-03-16
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for non-small cell lung cancer (nsclc)
  • • Phase3 - 850 participants
  • • A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Who can take part?

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

Where?

  • • Manchester - The Christie NHS Foundation Trust
  • • Newcastle upon Tyne - Local Institution - 0932
  • • Birmingham - Local Institution - 0928
  • • Cambridge - Addenbrooke's Hospital
  • • +8 more UK sites

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

About This Trial

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

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

EGFRALK

Treatment history

Treatments you must have had:

  • ✓ no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT)
  • ✓ an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC)...
  • ✓Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of...
  • ✓Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
  • ✓Participants must have an activity scale (ECOG) performance status (PS) score of 0 or 1.
See the full criteria
Inclusion Criteria * Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease. * Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy). * Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT). * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. Exclusion Criteria * Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements. * Participants must not have an active autoimmune disease. * Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage. * 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 current or suspected ILD or pneumonitis. * Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease. * Other protocol-defined Inclusion/Exclusion criteria apply.

Where Is This Study? (12 UK sites)

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Martin Igor Gomez Randulfe Rodriguez, Site 0239+44(0)161 446 3000

Local Institution - 0932

Newcastle upon Tyne NE77DN, United Kingdom

NOT_YET_RECRUITING

Local Institution - 0928

Birmingham B9 5SS, United Kingdom

NOT_YET_RECRUITING

Addenbrooke's Hospital

Cambridge CB2 2QQ, United Kingdom

Recruiting
Site contact (verified)
Huiqi Yang, Site 0672+44(0)1223 805000

Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

Recruiting
Site contact (verified)
paul shaw, Site 0289+44 29 2061 5888

The Royal Surrey County Hospital NHS Foundation Trust

Guildford GU2 7XX, United Kingdom

Recruiting
Site contact (verified)
Ajay Mehta, Site 0257+44 1483 571122

Local Institution - 0693

Leeds LS9 7TF, United Kingdom

WITHDRAWN

Clatterbridge Cancer Centre - Liverpool

Liverpool L9 7BA, United Kingdom

Recruiting
Site contact (verified)
Carles Escriu, Site 0232+44 151 556 5000

University College London Hospital

London NW1 2BU, United Kingdom

Recruiting
Site contact (verified)
Crispin Hiley, Site 0296+44 20 3456 7890

Royal Marsden Hospital (Chelsea)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Michael Davidson, Site 0235+44 20 7352 8171

Mount Vernon Hospital

Middlesex DA146LT, United Kingdom

Recruiting
Site contact (verified)
Suraiya Dubash, Site 0533+44 1923 826111

The Royal Marsden NHS Foundation Trust

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Michael Davidson, Site 0913+44(0)20 8642 6011

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