Estudio de fase III, abierto, aleatorizado y multicéntrico de ceralasertib más durvalumab versus docetaxel en pacientes con cáncer de pulmón de células no pequeñas avanzado o metastásico sin alteraciones genómicas accionables, cuya enfermedad progresó durante o después de terapia anti-PD-(L)1 y quimioterapia basada en platino: LATIFY

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05450692Tipo: INTERVENTIONALInicio: 15 de sept de 2022Fin estimado: 30 de oct de 2026

Resumen

Este estudio evaluará la eficacia y seguridad de la combinación de ceralasertib y durvalumab versus docetaxel como tratamiento estándar en pacientes con CPCNP localmente avanzado y metastásico tras progresión a terapia anti-PD-(L)1 y quimioterapia basada en platino.

Descripción detallada

Este estudio constará de dos brazos de tratamiento (grupos A y B). Los participantes serán aleatorizados en una proporción 1:1 a uno de los dos grupos de tratamiento: * Grupo A: Terapia combinada ceralasertib más durvalumab. Cada ciclo de 28 días comenzará con ceralasertib administrado por vía oral seguido de durvalumab administrado por vía intravenosa. * Grupo B: Monoterapia con docetaxel. Cada ciclo de 21 días comenzará con la administración de docetaxel.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.
Documented radiological PD whilst on or after receiving the most recent treatment regimen.
Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
Adequate organ function and marrow reserve
Minimum life expectancy of 12 weeks.
Body weight \> 30 kg and no cancer-associated cachexia.
Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).

Criterios de exclusión

Participant with mixed SCLC and NSCLC histology.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention.
Persistent toxicities (CTCAE Grade \> 2) caused by previous anticancer therapy.
Active or prior documented autoimmune or inflammatory disorders.
Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
Participants:
Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
Must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy.
Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \> 10 mg prednisone or equivalent per day.
Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.

Intervenciones

drug

Ceralasertib

Participants will receive ceralasertib oral tablets.

drug

Durvalumab

Participants will receive durvalumab as an intravenous infusion.

drug

Docetaxel

Participants will received docetaxel as an intravenous infusion.

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Pergamino, Argentina

Research Site

Rosario, Argentina

Research Site

Rosario, Argentina

Research Site

San Juan, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorParexel

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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