Resumen

El objetivo primario de este estudio es comparar el efecto de zimberelimab (ZIM) y domvanalimab (DOM) en combinación con quimioterapia respecto de pembrolizumab (PEMBRO) en combinación con quimioterapia sobre la supervivencia global (SG) en pacientes con cáncer de pulmón de células no pequeñas metastásico no tratado previamente sin alteración genómica accionable.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Zimberelimab

Administered intravenously

drug

Domvanalimab

Administered intravenously

drug

Pembrolizumab

Administered intravenously

drug

Carboplatin

Administered intravenously

drug

Cisplatin

Administered intravenously

drug

Paclitaxel

Administered intravenously

drug

Nab-paclitaxel

Administered intravenously

drug

Pemetrexed

Administered intravenously

Ubicaciones

Investigaciones CORI S.R.L.

Capital, Argentina

Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica

Cardoba, Argentina

Sanatorio Allende

Córdoba, Argentina

Sanatorio Britanico de Rosario

Rosario, Argentina

Sanatorio Parque de Rosario

Rosario, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina

Clínica Viedma

Viedma, Argentina

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Zimberelimab

Domvanalimab

Pembrolizumab

Carboplatin

Cisplatin

Paclitaxel

Nab-paclitaxel

Pemetrexed

Ubicaciones

Investigaciones CORI S.R.L.

Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica

Sanatorio Allende

Sanatorio Britanico de Rosario

Sanatorio Parque de Rosario

Hospital Provincial del Centenario

Instituto Medico de la Fundacion Estudios Clinicos

Clínica Viedma

Patrocinadores