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RecruitingLast updated: 10 July 2026

ROSETTA Lung-201: Comparing two immunotherapies for the treatment of stage III unresectable non-small cell lung cancer in people who have had concurrent chemoradiotherapyA 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.

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

ROSETTA Lung-201

Clinical summary

Summary

You may be eligible for this study if you have non-small cell lung cancer that is stage III and unable to be removed with surgery (unresectable). You must also have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (CCRT) and not had progressive disease.

Eligible participants will be randomly allocated (by chance) to receive either Pumitamig or Durvalumab.

Conditions

This trial is treating people with non-small cell lung cancer

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Bristol-Myers Squibb

Scientific Title

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.

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