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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)
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

RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Non-small Cell Lung Cancer (NSCLC)

Interventions: Pumitamig, Durvalumab

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (258)
  • Daphne, Alabama, United States
  • Chandler, Arizona, United States
  • Golden, Colorado, United States
  • Newark, Delaware, United States
  • Ocala, Florida, United States
  • Marietta, Georgia, United States
  • Chicago, Illinois, United States
  • Evanston, Illinois, United States
  • Peoria, Illinois, United States
  • Fort Wayne, Indiana, United States
  • Lexington, Kentucky, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Maple Grove, Minnesota, United States
  • Saint Paul, Minnesota, United States
  • Columbia, Missouri, United States
  • New York, New York, United States
  • Westbury, New York, United States
  • Westbury, New York, United States
  • Winston-Salem, North Carolina, United States
  • Akron, Ohio, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Cleveland, Ohio, United States
  • Mayfield Heights, Ohio, United States
  • Eugene, Oregon, United States
  • Happy Valley, Oregon, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Amarillo, Texas, United States
  • + 228 more on CT.gov