Estudio de fase 3, aleatorizado, doble ciego, de pembroli... | EligiMed

Estudio de fase 3, aleatorizado, doble ciego, de pembrolizumab adyuvante con o sin V940 en participantes con NSCLC resecable en estadio II a IIIB (N2) que no alcanzaron pCR tras recibir pembrolizumab neoadyuvante con quimioterapia doble basada en platino (INTerpath-009)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06623422Tipo: INTERVENTIONALInicio: 21 de oct de 2024Fin estimado: 26 de ene de 2038

Resumen

El objetivo de este estudio es determinar si las personas que reciben intismeran autogene y pembrolizumab después de la cirugía permanecen libres de cáncer por más tiempo que las personas que reciben placebo y pembrolizumab. Los investigadores quieren saber si administrar intismeran autogene y pembrolizumab después de la cirugía puede ayudar a prevenir la recurrencia del cáncer en personas con cáncer de pulmón de células no pequeñas (NSCLC) cuyos tumores no respondieron completamente al tratamiento previo a la cirugía (tratamiento neoadyuvante).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American Joint Committee on Cancer (AJCC) 8th Edition\]
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\])
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Criterios de exclusión

Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor
Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
Received prior neoadjuvant therapy for their current NSCLC diagnosis
Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein \[CTLA-4\], OX-40, CD137)
Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
Received prior treatment with a cancer vaccine
Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

Intervenciones

biological

Pembrolizumab

IV Infusion

drug

Cisplatin

IV infusion

drug

Carboplatin

IV infusion

drug

Pemetrexed

IV infusion

drug

Gemcitabine

IV infusion

drug

Paclitaxel

IV infusion

biological

Intismeran autogene

IM injection

other

Placebo

IM injection

Ubicaciones

CEMIC ( Site 2454)

Caba., Buenos Aires, Argentina

Study Coordinator · 5411529901002543

RECRUITING

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2459)

Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina

Study Coordinator · 49590200

RECRUITING

Fundacion Intecnus ( Site 2456)

Bariloche, Río Negro Province, Argentina

Study Coordinator · 0294154293757

RECRUITING

Centro Médico IPAM ( Site 2452)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +543414858585

RECRUITING

Instituto Medico Especializado Alexander Fleming ( Site 2457)

Buenos Aires, Argentina

Study Coordinator · +541132218900

RECRUITING

Instituto Oncologico de Cordoba -IONC ( Site 2455)

Córdoba, Argentina

Study Coordinator · 5493516165267

RECRUITING

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

ColaboradorModernaTX, Inc.

Contactos

Toll Free Number

CONTACT

Trialsites@msd.com 1-888-577-8839

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.