Resumen

El objetivo de este estudio es evaluar intismeran autogene más pembrolizumab frente a placebo más pembrolizumab para el tratamiento adyuvante del cáncer de pulmón de células no pequeñas (CPCNP) con resección completa de márgenes negativos en estadio II, IIIA, IIIB (con afectación ganglionar [N2]). La hipótesis principal es que intismeran autogene más pembrolizumab es superior a placebo más pembrolizumab en cuanto a la supervivencia libre de enfermedad (SLE) evaluada por el investigador.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
Has no evidence of disease before randomization.
Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
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.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).

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.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Received prior neoadjuvant therapy for their current NSCLC diagnosis.
Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
Known additional malignancy that is progressing or has required active treatment within the past 5 years.
Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Active infection requiring systemic therapy.

Ubicaciones

Clinica Adventista Belgrano-Oncology ( Site 2901)

Caba., Buenos Aires, Argentina

Study Coordinator · +54 911 32682903

RECRUITING

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2912)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · +541149590200

RECRUITING

Instituto Alexander Fleming ( Site 2911)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · +541132218900

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 2908)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · +5492235937663

RECRUITING

Fundacion Estudios Clinicos-Oncology ( Site 2907)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +549346969922

RECRUITING

Sanatorio Parque ( Site 2904)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +543414200222

RECRUITING

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Intismeran autogene

Pembrolizumab

Placebo

Ubicaciones

Clinica Adventista Belgrano-Oncology ( Site 2901)

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2912)

Instituto Alexander Fleming ( Site 2911)

Instituto de Investigaciones Clínicas Mar del Plata ( Site 2908)

Fundacion Estudios Clinicos-Oncology ( Site 2907)

Sanatorio Parque ( Site 2904)

Patrocinadores

Contactos

Toll Free Number