Last updated 43 days ago
Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer
1069 patients around the world
Available in Brazil, Argentina, Mexico, Chile
Gilead Sciences
22Research sites
1069Patients 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
- Life expectancy ≥ 3 months.Pathologically documented NSCLC that meets both of the criteria below:Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition).Have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations.Have no actionable genomic alterations such as ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other driver oncogenes with approved frontline therapies.Have not received prior systemic treatment for metastatic NSCLC.Measurable disease per RECIST v1.1 criteria by investigator assessment.Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.Have adequate organ functions.
- Have mixed small-cell lung cancer (SCLC) and NSCLC histology.Positive serum pregnancy test or individuals who are breastfeeding or have plans to breastfeed during the study period.Received prior treatment with any anti-PD-1, anti-PD-L1, or any other antibody targeting an immune checkpoint.Known hypersensitivity to the study drug, its metabolites, or formulation excipient.Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.Have an active autoimmune disease that required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).Are receiving chronic systemic steroids.Have significant third-space fluid retention.Have untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.Has had an allogenic tissue/solid organ transplant.Have received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Sites
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Swiss Medical Center Barrio Parque - CABA
Sanatorio Allende (Nueva Córdoba)
Recruiting
Sanatorio Británico - Rosario
Recruiting
Sanatorio Parque - Rosario
Recruiting
Centro Médico Caipo (centro para la atención integral de pacientes oncológicos)
StudySTAR-121
SponsorGilead Sciences
Study typeInterventional
Conditions
Non-small cell lung carcinomaLung cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05502237
