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Study of Pumitamig vs. Durvalumab for Stage III Lung Cancer

This study is looking at two medicines, Pumitamig and Durvalumab, for people with unresectable Stage III non-small cell lung cancer (NSCLC). "Unresectable" means the cancer cannot be removed by surgery. You may be able to join if you are 18 or older, have this type of lung cancer, and have already received at least two cycles of platinum-based chemotherapy and radiation therapy. The study aims to see if Pumitamig or Durvalumab can help people live longer without their cancer getting worse. We are measuring this over up to 3 years. The study is currently recruiting 850 participants, but its overall status is unclear.

Study design
This is an interventional study comparing two different drugs, Pumitamig and Durvalumab. It plans to enroll 850 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 years to measure how long they live without their cancer progressing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07361497

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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~850 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:PumitamigDurvalumab

At a glance

Recruiting sites
158 of 258 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Measured over Up to 3 years

Conditions

Non-small Cell Lung Cancer (NSCLC)

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

258 sites across 150 states
United Kingdom9
Germany8
Texas7
Romania6
Turkey (Türkiye)6
Ohio5
Bulgaria5
Spain5

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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.

What this trial measures

  • Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)Up to 3 years