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Taking people in ItalyPhase 3

Pumitamig compared with durvalumab after chemoradiation for non-small cell lung cancer

Compares pumitamig with durvalumab in adults whose lung cancer cannot be removed surgically.

Key facts

Who runs it
Bristol-Myers Squibb
Where
Aviano, Milan, Naples, Orbassano, Parma, Ravenna, and Rome, ItalySee the 8 sitesAlso in 31 other countries, 248 sites
Trial code
Registry title
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)
Status
Recruiting
Phase
Phase 3
People taking part
850 people, planned
Started
16 Mar 2026
Expected to end
13 Jan 2034
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Pumitamig
  • Durvalumab
Record updated
5 November 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 non-small cell lung cancer (NSCLC) that cannot be removed by surgery (stage III). Their cancer must not have grown after chemotherapy given together with radiation.

Age
18 years or older
Sex
All sexes can join
Disease stage
Non-small cell lung cancer, stage III, cannot be removed by surgery, confirmed by tissue or cell tests
Earlier treatment
Must have had at least 2 cycles of platinum-based chemotherapy given together with radiation (total radiation dose at least 54 Gy), with no cancer growth afterwards. Must not have had other cancer treatment for stage III disease.
Biomarker or test result
If the cancer is non-squamous, it must not have documented EGFR or ALK gene rearrangements.

Main reasons for not taking part

  • Active autoimmune disease
  • Serious heart or blood vessel problems, such as uncontrolled high blood pressure or heart failure
  • Serious lung disease, or past or current interstitial lung disease or pneumonitis
  • Other cancer treatment for stage III disease apart from chemoradiation

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Participants must not have an active autoimmune disease
  • Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements
  • 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?

Where in Italy

Also in 31 other countries, 248 sites

  • Centro di Riferimento Oncologico di AvianoAviano, ItalyTaking people
  • Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people
  • Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
  • IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
  • Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyTaking people
  • Azienda Ospedaliero Universitaria ParmaParma, ItalyTaking people
  • Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyTaking people
  • Università Campus Bio-Medico di RomaRome, ItalyTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Arm ATreatment being tested

    Treatment: Pumitamig

  • Arm BExisting treatment, for comparison

    Treatment: Durvalumab

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-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy.
Plain-language title
Pumitamig compared with durvalumab after chemoradiation for non-small cell 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 NCT07361497, who can take part
Record updated
5 November 2026
Under construction, not live – 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) (NCT07361497) – Frontlight Research