Resumen

El objetivo primario del estudio es comparar sacituzumab tirumotecan combinado con pembrolizumab frente a pembrolizumab solo con respecto a la supervivencia global (SG). La hipótesis primaria es que la combinación de sacituzumab tirumotecan y pembrolizumab es superior a pembrolizumab solo en cuanto a SG. Todos los participantes que hayan completado el primer ciclo de pembrolizumab pueden ser elegibles para recibir hasta 9 ciclos adicionales de pembrolizumab en monoterapia si se verifica mediante revisión central independiente enmascarada (RCIM) progresión de enfermedad según los Criterios de Evaluación de Respuesta en Tumores Sólidos versión 1.1 (RECIST 1.1) tras el tratamiento inicial.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC
Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
A life expectancy of at least 3 months.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Criterios de exclusión

Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
Has Grade ≥2 peripheral neuropathy.
History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
Received prior systemic anticancer therapy for their metastatic NSCLC.
Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Received radiation therapy to the lung that is \>30 Gy within 6 months of start of study intervention.
Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.
Active autoimmune disease that has required systemic treatment in the past 2 years.
History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
Active infection requiring systemic therapy
Concurrent active Hepatitis B and Hepatitis C virus infection.
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
History of allogeneic tissue/solid organ transplant.
Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.

Intervenciones

biological

Sacituzumab tirumotecan

IV infusion

biological

Pembrolizumab

IV infusion

drug

Supportive care measures

Participants are allowed to take supportive care measures at the discretion of the investigator. Prophylactic supportive care measures may include but are not limited to antiemetic agents, antidiarrheal agents, granulocyte and erythroid growth factors, and blood transfusions

Ubicaciones

Instituto Alexander Fleming ( Site 0306)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · +54 9 011-3221-8900

RECRUITING

Hospital Británico de Buenos Aires-Oncology ( Site 0304)

Buenos Aires, Buenos Aires F.D., Argentina

Study Coordinator · +541143096807

RECRUITING

Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)

Río Cuarto, Córdoba Province, Argentina

Study Coordinator · +54351153819050

RECRUITING

Instituto de Oncología de Rosario ( Site 0301)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +549-341-5778394

RECRUITING

Hospital Aleman-Oncology ( Site 0300)

Buenos Aires, Argentina

Study Coordinator · +54 9 115662 5455

RECRUITING

Estudio de Fase 3, Aleatorizado y Abierto de MK-2870 en Combinación con Pembrolizumab Comparado con Pembrolizumab en Monoterapia como Tratamiento de Primera Línea en Participantes con Cáncer de Pulmón de Células no Pequeñas Metastásico con TPS de PD-L1 Mayor o Igual al 50% (TroFuse-007)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Sacituzumab tirumotecan

Pembrolizumab

Supportive care measures

Ubicaciones

Instituto Alexander Fleming ( Site 0306)

Hospital Británico de Buenos Aires-Oncology ( Site 0304)

Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)

Instituto de Oncología de Rosario ( Site 0301)

Hospital Aleman-Oncology ( Site 0300)

Patrocinadores

Contactos

Toll Free Number