Estudio de plataforma de fase 1b/2, multicéntrico, abierto, de combinaciones seleccionadas de inmunoterapia en participantes adultos con cáncer de pulmón de células no pequeñas (CPCNP) avanzado no tratado previamente con alta expresión de PD-L1

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT06162572Tipo: INTERVENTIONALInicio: 7 de ago de 2024Fin estimado: 1 de jul de 2027

Resumen

Este es un estudio de fase 1b/2 que evalúa el anticuerpo anti-PD1 cemiplimab, en combinación con S095018 (anticuerpo anti-TIM3), S095024 (anticuerpo anti-CD73) o S095029 (anticuerpo anti-NKG2A) en participantes adultos con cáncer de pulmón de células no pequeñas (CPCNP) avanzado/metastásico no tratado previamente con alta expresión de PD-L1. El estudio incluye dos partes: la parte A, la fase de introducción de seguridad de la terapia combinada para determinar la dosis recomendada de expansión (RDE) para S095018, S095024 y S095029 en combinación con cemiplimab, y la parte B, la fase de expansión de dosis aleatorizada para evaluar la eficacia de S095018, S095024 o S095029 en combinación con cemiplimab. El tratamiento del estudio se administrará durante un máximo de 108 semanas, o hasta la progresión de la enfermedad confirmada según iRECIST y/o hasta cumplir con otros criterios de discontinuación del tratamiento.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Adult patient aged ≥ 18 years
Written informed consent
Histologically (squamous or non-squamous) or cytologically documented locally advanced NSCLC not eligible for surgical resection and/or definitive chemoradiation, or metastatic NSCLC
No prior systemic treatment for locally advanced or metastatic NSCLC
High tumor cell PD-L1 expression \[Tumor Proportion Score (TPS) ≥50%\] based on documented status as determined by an approved test
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Measurable disease as determined by RECIST v1.1

Criterios de exclusión

Tumors harboring driver mutations/genetic aberrations for which targeted therapies are approved as frontline treatment (e.g. EGFR mutation, ALK fusion oncogene, ROS1 aberrations)
Prior immune checkpoint inhibitor therapy
Active brain metastases
Participants with active and uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Uncontrolled HIV infection. Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are allowed to enroll
Active, known or suspected autoimmune disease or immune deficiency
History of hypersensitivity reactions to any ingredient of the investigational medicinal product (IMP) and other monoclonal antibody (mAbs) and/or their excipients
History of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis ≥ grade 2
History of inflammatory bowel disease or colitis ≥ grade 2
History of hemophagocytic lymphohistiocytosis.
Systemic chronic steroid therapy (\>10mg/d prednisone or equivalent)
Clinically significant infection, as assessed by the investigator
Pregnant or breast-feeding (lactating) women
Participants with a history of allogeneic organ transplantation (e.g., stem cell or solid organ transplant)
Any medical condition that would in the investigator's judgement prevent the participant's participation in the clinical study