Last updated 21 days ago
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)
850 patients around the world
Available in Puerto Rico, Chile, Argentina, United States, Mexico, Brazil, Belgium, Spain
Bristol-Myers Squibb
7Research sites
850Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 chemotherapy (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.
- 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.
Sites
Instituto de Investigaciones Clínicas Córdoba
Recruiting
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Instituto Argentino de Diagnóstico y Tratamiento - IADT
Recruiting
Hospital Privado de Córdoba
Recruiting
Sanatorio Parque - Rosario
Recruiting
StudyROSETTA Lung-201
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07361497
