Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
To 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.