ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.

Aún no reclutaFase 3ClinicalTrials.gov

ID: NCT07361510Tipo: INTERVENTIONALInicio: 9 de abr de 2026Fin estimado: 14 de oct de 2031

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease.
Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%.
Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

Criterios de exclusión

Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated.
Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression.
Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage.
Participants must not an active autoimmune disease.

Intervenciones

drug

Pumitamig

Specified dose on specified days

drug

Pembrolizumab

Specified dose on specified days

Ubicaciones

Local Institution - 0076

Mar del Plata, Buenos Aires, Argentina

Site 0076

Local Institution - 0229

Rosario, Santa Fe Province, Argentina

Site 0229

Local Institution - 0362

Rosario, Santa Fe Province, Argentina

Site 0362

Local Institution - 0058

Buenos Aires, Argentina

Site 0058

Local Institution - 0374

Córdoba, Argentina

Site 0374

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorBioNTech SE

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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