Calendario›BYSI›Docetaxel + Plinabulin · DUBLIN-3
Docetaxel + Plinabulin · DUBLIN-3
Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC
Ensayo de BeyondSpring Inc. en Cancer de pulmon no microcitico.
Más ensayos de: Cáncer de pulmón no microcítico.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 559
- Centros
- 57
- Fin del objetivo primario
- jul 2021
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, simple ciego. Comenzó en dic 2015.
Qué mide
Supervivencia global (The time (Days) from the date of randomization to the date of death, up to 48 months) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroTo compare the overall survival of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease. Secondary purposes of the study are: * To compare overall response rate (ORR) of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease. * To compare progression free survival (PFS) of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease. * To compare incidence of Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 0.5 × 109/L) on Day 8 (+/- 1 day) of Cycle 1 of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease. * To compare 24-month and 36-month OS rate of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease.
Más ensayos de BYSI
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Plinabulin | Fase 3 | Aún sin reclutar | jun 2029 (prevista) |
| Pegfilgrastim | Fase 3 | Sin noticias del promotor | sep 2020 (real) |
| Plinabulin · Protective-1 | Fase 3 | Completado | dic 2018 (real) |
| Plinabulin | Fase 2 | Completado | oct 2018 (real) |
| Plinabulin | Fase 2 | Completado | mar 2018 (real) |
Todos los de BYSI, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02504489), actualizada en may 2026.