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Pumitamig versus durvalumab after chemoradiation for unresectable stage III NSCLC

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.

PHASE3 · Bristol-Myers Squibb · NCT07361497

This trial tests whether Pumitamig or durvalumab works better to keep unresectable stage III non-small cell lung cancer from coming back after concurrent chemoradiation.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment850 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb (industry)
Drugs / interventionsradiation, Durvalumab
Locations254 sites (Daphne, Alabama and 253 other locations)
Trial IDNCT07361497 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial enrolls people with unresectable stage III NSCLC who have completed at least two cycles of platinum-based concurrent chemoradiotherapy (including radiation ≥54 Gy) and who have no progressive disease after treatment. Participants will be assigned to receive either Pumitamig or durvalumab as consolidation therapy and will be followed for disease progression, survival, and side effects. Key exclusions include non-squamous tumors with documented EGFR or ALK alterations, active autoimmune disease, and significant cardiovascular impairment. The study directly compares efficacy and safety outcomes between the two drugs in this post-chemoradiation setting.

Who should consider this trial

Good fit: Adults with histologically or cytologically confirmed unresectable Stage III NSCLC who completed at least two cycles of platinum-based concurrent chemoradiotherapy (radiation ≥54 Gy), have no progressive disease after CCRT, and have ECOG performance status 0 or 1 are the intended participants.

Not a fit: Patients with non-squamous NSCLC harboring EGFR or ALK alterations, those with active autoimmune disease, significant uncontrolled cardiovascular conditions, or those with progressive disease after CCRT are unlikely to qualify or benefit from the trial.

Why it matters

Potential benefit: If successful, the trial could identify a consolidation therapy that prolongs the time without cancer growth and may improve survival after chemoradiation.

How similar studies have performed: Durvalumab has previously shown improved progression-free and overall survival as consolidation after chemoradiation in the PACIFIC trial, while Pumitamig is a newer agent now being tested directly against durvalumab.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Daphne, Alabama and 253 other locations

+204 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-small Cell Lung Cancer, Pumitamig, Locally advanced, Unresectable, Stage 3 Non-small Cell Lung Cancer, CA2660001

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.