USO 23080
Estudio de fase 3, en dos fases, aleatorizado de ONC-392 frente a docetaxel en cánceres de pulmón metastásicos de células no pequeñas que progresaron con inhibidores de PD-1/PD-L1 (PRESERVE-003).
Tipos de enfermedades: Investigación sobre el cáncer de pulmón
Requisitos de elegibilidad:
1. Adult (> 18 years), all genders, capable of signing informed consent.
2. Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC, metastasis can be regional lymph nodes or distant organs.
3. Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b:
1. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy;
2. Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy.
Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed. 4. At least one measurable tumor lesion according to RECIST 1.1. 5. ECOG score of 0 or 1. 6. Adequate organ functions. Serum LDH level < 2xULN. 7. Life expectancy > 3 months.
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