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 the neutropenia (incidence of Grade 4 neutropenia [absolute neutrophil count (ANC) < 0.5 × 10^9/L]) on Day 8 (+/- 1 day) of Cycle 1), DoR, neutrophil count on Day 8 (+/- 1 day) of Cycle 1, incidence of docetaxel dose reduction and/or docetaxel dose withheld in Cycle 2 due to neutropenia in Cycle 1, QoL (EORTC QLQ-C30 [item 30, average overall quality of life over all observable weeks]), ORR, and PFS in patients with NSCLC treated in the DP Arm to patients treated in the D Arm as 2nd- or 3rd-line therapy for advanced or metastatic disease. - To compare the safety and adverse events profile of the DP Arm to D Arm. - To compare dose intensity of docetaxel (percent dose administered compared to dose assigned) between the 2 treatment arms. - To evaluate population pharmacokinetics in patients enrolled in China and rest of world (RoW).
Name: Docetaxel + Plinabulin (DP)
Name: Docetaxel (D)
Description: Overall survival of NSCLC patients receiving 2nd- or 3rd-line systemic therapy
Measure: Overall Survival Time: Approximately 2 years after study initiationDescription: Incidence of Grade 4 neutropenia on Day 8 of Cycle 1
Measure: Grade 4 neutropenia Time: During 1st 21-day cycleDescription: Neutrophil count on Day 8 of Cycle 1
Measure: Neutrophil count Time: During 1st 21-day cycleDescription: incidence of docetaxel dose reduction and/or docetaxel dose withheld in Cycle 2 due to neutropenia in Cycle 1
Measure: docetaxel dose reduction and/or docetaxel dose withheld Time: During 2nd 21-day cycleDescription: Average Quality of Life score over all observed weeks (scale 0 - 30, higher value represents better outcome)
Measure: Quality of Life (EORTC QLQ-C30) Time: Approximately 2 years after study initiation.Description: Overall response rate
Measure: ORR Time: Approximately 2 years after study initiation.Description: Progress-free survival
Measure: PFS Time: Approximately 2 years after study initiation.Description: Duration of response
Measure: DoR Time: Approximately 2 years after study initiation.Allocation: Randomized
Parallel Assignment
There is one SNP
Radiographic tumor assessment is to be performed within 28 days prior to randomization. 5. patients with nonsquamous NSCLC must have been tested for EGFR exon 19 deletion and Exon 21 L858R substitution mutation. --- L858R ---