Trial Outcomes & Findings for Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC (NCT NCT02504489)

Last Updated: 2026-05-19

Results Overview

Overall survival is defined as the time (days) from the date of randomization to the date of death due to any cause (i.e., Date of death - date of randomization +1).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

559 participants

Primary outcome timeframe

The time (Days) from the date of randomization to the date of death, up to 48 months

Results posted on

2026-05-19

Participant Flow

919 patients were screened for inclusion, and 360 patients were excluded due to failure to meet entry criteria, adverse events, and other reasons.

Participant milestones

Participant milestones
Measure	Docetaxel (D) A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Overall Study STARTED	281	278
Overall Study Treated	281	278
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	281	278

Reasons for withdrawal

Reasons for withdrawal
Measure	Docetaxel (D) A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Overall Study Death	230	214
Overall Study Withdrawal by Subject	18	16
Overall Study Lost to Follow-up	2	2
Overall Study Alive at database lock	25	39
Overall Study Alive at project end	6	7

Baseline Characteristics

Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel (D) n=281 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=278 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV	Total n=559 Participants Total of all reporting groups
Age, Continuous	59.8 years STANDARD_DEVIATION 9.41 • n=30 Participants	60.6 years STANDARD_DEVIATION 8.96 • n=30 Participants	60.2 years STANDARD_DEVIATION 9.19 • n=60 Participants
Sex: Female, Male Female	74 Participants n=30 Participants	79 Participants n=30 Participants	153 Participants n=60 Participants
Sex: Female, Male Male	207 Participants n=30 Participants	199 Participants n=30 Participants	406 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Asian	248 Participants n=30 Participants	244 Participants n=30 Participants	492 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	6 Participants n=30 Participants	3 Participants n=30 Participants	9 Participants n=60 Participants
Race (NIH/OMB) White	25 Participants n=30 Participants	29 Participants n=30 Participants	54 Participants n=60 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=30 Participants	2 Participants n=30 Participants	4 Participants n=60 Participants
Tumor histology Non-squamous	178 Participants n=30 Participants	154 Participants n=30 Participants	332 Participants n=60 Participants
Tumor histology Squamous	100 Participants n=30 Participants	120 Participants n=30 Participants	220 Participants n=60 Participants
Tumor histology Missing	3 Participants n=30 Participants	4 Participants n=30 Participants	7 Participants n=60 Participants
ECOG score 0 (Fully active, able to carry on all pre-disease performance without restriction)	44 Participants n=30 Participants	40 Participants n=30 Participants	84 Participants n=60 Participants
ECOG score 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light)	225 Participants n=30 Participants	229 Participants n=30 Participants	454 Participants n=60 Participants
ECOG score 2 (Ambulatory and capable of all selfcare but unable to carry out any work activities)	11 Participants n=30 Participants	9 Participants n=30 Participants	20 Participants n=60 Participants
ECOG score Missing value	1 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants
Regional distribution Asian	245 Participants n=30 Participants	243 Participants n=30 Participants	488 Participants n=60 Participants
Regional distribution Non-Asian	36 Participants n=30 Participants	35 Participants n=30 Participants	71 Participants n=60 Participants
Cancer stage IIIB (The Cancer has spread extensively to the lymph nodes in the chest)	41 Participants n=30 Participants	50 Participants n=30 Participants	91 Participants n=60 Participants
Cancer stage IV (The cancer is in both lungs or has spread to other parts of the body)	236 Participants n=30 Participants	224 Participants n=30 Participants	460 Participants n=60 Participants
Cancer stage Missing value (no staging recorded)	4 Participants n=30 Participants	4 Participants n=30 Participants	8 Participants n=60 Participants
Previous PD-1 or PD-L1 therapy received Yes	57 Participants n=30 Participants	49 Participants n=30 Participants	106 Participants n=60 Participants
Previous PD-1 or PD-L1 therapy received No	224 Participants n=30 Participants	229 Participants n=30 Participants	453 Participants n=60 Participants
Line of previous therapy First-line	212 Participants n=30 Participants	204 Participants n=30 Participants	416 Participants n=60 Participants
Line of previous therapy Second-line	69 Participants n=30 Participants	74 Participants n=30 Participants	143 Participants n=60 Participants
Previous radiotherapy Yes	84 Participants n=30 Participants	87 Participants n=30 Participants	171 Participants n=60 Participants
Previous radiotherapy No	197 Participants n=30 Participants	191 Participants n=30 Participants	388 Participants n=60 Participants
Previous surgery Yes	138 Participants n=30 Participants	123 Participants n=30 Participants	261 Participants n=60 Participants
Previous surgery No	143 Participants n=30 Participants	155 Participants n=30 Participants	298 Participants n=60 Participants

PRIMARY outcome

Timeframe: The time (Days) from the date of randomization to the date of death, up to 48 months

Population: All randomized participants

Overall survival is defined as the time (days) from the date of randomization to the date of death due to any cause (i.e., Date of death - date of randomization +1).

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=281 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=278 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Overall Survival	9.4 months Interval 8.38 to 10.68	10.5 months Interval 9.34 to 11.87

SECONDARY outcome

Timeframe: up to 2 years after study Initiation

Population: All randomized participants

Overall response rate

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=281 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=278 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
ORR	24 Participants	39 Participants

SECONDARY outcome

Timeframe: Up to 48 months after study initiation.

Population: All randomized participants

Progress-free survival

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=281 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=278 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
PFS	2.8 months Interval 2.76 to 2.93	3.3 months Interval 2.89 to 3.88

SECONDARY outcome

Timeframe: Day 8 of Cycle 1 (±1 day)

Population: All participants who received at least 1 dose of study treatment

Percent of patients without severe neutropenia on Day 8 of Cycle 1

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=241 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=228 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Severe Neutropenia	174 Participants	216 Participants

SECONDARY outcome

Timeframe: up to 24months after study initiation

Population: All randomized participants

To compare 24-month overall survival rate

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=281 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=278 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Month 24 OS Rate	12.51 percentage of participants Interval 7.99 to 17.02	22.13 percentage of participants Interval 16.76 to 27.51

SECONDARY outcome

Timeframe: up to 36 months after study initiation

Population: All randomized participants

To compare 36-month overall survival rate

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=281 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=278 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Month 36 OS Rate	5.27 percentage of participants Interval 1.8 to 8.73	11.73 percentage of participants Interval 6.65 to 16.81

SECONDARY outcome

Timeframe: Up to 2 years after study initiation.

Duration of response

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=24 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=39 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
DoR	6.1 months Interval 3.65 to 7.86	8.3 months Interval 4.37 to 20.48

SECONDARY outcome

Timeframe: Baseline and End of Treatment (Last study assessment prior to treatment discontinuation), assessed up to 2 years after study initiation.

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status / Quality of Life scale was used. The Global Health Status / Quality of Life scale is transformed to a 0-100 scale according to the EORTC scoring manual. Minimum value: 0 Maximum value: 100 Higher scores indicate better quality of life The reported values represent the mean change from baseline to end of treatment (end of treatment score minus baseline score).

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=265 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=253 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Change From Baseline in EORTC QLQ-C30 Global Health Status / Quality of Life Score	-5.48 Score on a 0-100 scale Standard Error 0.600	-7.74 Score on a 0-100 scale Standard Error 0.557

SECONDARY outcome

Timeframe: up to 2 years after study initiation.

To compare the mean difference in quality-adjusted time without symptoms of disease and toxicity

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=281 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=278 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Q-TWiST	10.47 Months Interval 9.34 to 11.63	12.40 Months Interval 10.99 to 13.83

SECONDARY outcome

Timeframe: Up to 2 years after study initiation.

EORTC QLQ C30/QLQ LC13, this instrument consists of one multi-item dyspnea scale and several single item symptom scales (e.g. pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia and hemoptysis). All LC13 symptom scales were scored according to the EORTC QLQ C30/QLQ LC13 scoring manuals. On this 0-100 scale, higher scores represent a higher level of symptoms (worse outcome). The QLQ LC13 Symptom Combined Score used for this outcome is the average of all available LC13 symptom scale scores, if all 3 dyspnea items are non-missing, the dyspnea scale score and all other symptom scales are calculated and the Symptom Combined Score is the average of all available scales. The reported LSMeans (SE) and LSMeans differences (95% CI) are based on this 0-100 Symptom Combined Score, where 0 indicates no lung cancer-related symptoms and 100 indicates the highest level of symptoms.

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=266 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=251 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
QoL (QLQ-LC13)	4.44 score on a scale Standard Error 0.326	4.32 score on a scale Standard Error 0.303

SECONDARY outcome

Timeframe: Up to 29 cycles

Population: All randomized participants

To compare proportion of patients who received docetaxel \>8 cycles, \>10 cycles, and \>12 cycles

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=281 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=278 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Proportion of Patients Who Received Docetaxel No. of subjects who received docetaxel >8 cycles	21 Participants	28 Participants
Proportion of Patients Who Received Docetaxel No. of subjects who received docetaxel >10 cycles	13 Participants	17 Participants
Proportion of Patients Who Received Docetaxel No. of subjects who received docetaxel >12 cycles	4 Participants	13 Participants
Proportion of Patients Who Received Docetaxel No. of subjects who received docetaxel ≦8 cycles	243 Participants	220 Participants

SECONDARY outcome

Timeframe: up to 18 months after study initiation

Population: All randomized participants

To compare 18-month overall survival rate

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=281 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=278 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Month 18 OS Rate	23.75 percentage of participants Interval 18.4 to 29.09	31.11 percentage of participants Interval 25.42 to 36.81

SECONDARY outcome

Timeframe: First Cycle 1 Day 1 to the end of Cycle 12 (approximately up to 36 weeks)

Population: Evaluable population, defined as participants with available data for the analysis; the largest evaluable sample size was observed at Cycle 4.

Relative Dose Intensity (RDI) was defined as the ratio of the actual delivered dose intensity to the planned dose intensity of docetaxel. Dose intensity was calculated as the total dose (mg/m²) divided by the actual cycle duration (days) and normalized to the planned 21-day treatment cycle. Thus, RDI = \[(Actual dose / actual duration) / (Planned dose / 21 days)\]. RDI values were summarized as mean (SD), median, and range per treatment group after 4, 6, 8, 10, and 12 cycles." Note: Analysis population: ITT (Docetaxel \[D\] n=281; Docetaxel + Plinabulin \[DP\] n=278). Means (SD) were calculated using participants with available data at each duration; therefore, the number analyzed varies by row.

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=128 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=133 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Analysis of the Relative Dose Intensity of Docetaxel Over the First 4, 6, 8, 10, 12 Cycles First 4 cycles	0.925 Ratio (unitless) Standard Deviation 0.10	0.918 Ratio (unitless) Standard Deviation 0.09
Analysis of the Relative Dose Intensity of Docetaxel Over the First 4, 6, 8, 10, 12 Cycles First 6 cycles	0.916 Ratio (unitless) Standard Deviation 0.10	0.899 Ratio (unitless) Standard Deviation 0.11
Analysis of the Relative Dose Intensity of Docetaxel Over the First 4, 6, 8, 10, 12 Cycles First 8 cycles	0.920 Ratio (unitless) Standard Deviation 0.11	0.900 Ratio (unitless) Standard Deviation 0.11
Analysis of the Relative Dose Intensity of Docetaxel Over the First 4, 6, 8, 10, 12 Cycles First 10 cycles	0.892 Ratio (unitless) Standard Deviation 0.13	0.899 Ratio (unitless) Standard Deviation 0.11
Analysis of the Relative Dose Intensity of Docetaxel Over the First 4, 6, 8, 10, 12 Cycles First 12 cycles	0.902 Ratio (unitless) Standard Deviation 0.11	0.884 Ratio (unitless) Standard Deviation 0.10

SECONDARY outcome

Timeframe: up to 12 months after study initiation

Population: All randomized participants

To compare 12-month overall survival rate

Outcome measures

Outcome measures
Measure	Docetaxel (D) n=281 Participants A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=278 Participants The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Month 12 OS Rate	40.47 percentage of participants Interval 34.51 to 46.44	43.48 percentage of participants Interval 37.48 to 49.47

Adverse Events

Docetaxel (D)

Serious events: 92 serious events

Other events: 269 other events

Deaths: 230 deaths

Docetaxel + Plinabulin (DP)

Serious events: 115 serious events

Other events: 270 other events

Deaths: 214 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel (D) n=278 participants at risk A treatment cycle is 21 days. Treatment will be repeated until disease progression is detected by imaging studies or unacceptable toxicities are encountered. On Day 1, all patients will receive docetaxel 75 mg/m2 by intravenous (IV) infusion over 1 hour. Oral dexamethasone (16 mg, given as 8 mg twice daily) will be given on the day prior to, the day of (Day 1), and the day following docetaxel infusion (Day 2). Antiemetic prophylaxis will be administered according to institutional guideline for docetaxel. Institutional guideline/practice should be followed in the event of infusion/hypersensitivity reaction. Diphenhydramine and dexamethasone infusion may be administered in the event of infusion reaction. Docetaxel (D): Docetaxel 75 mg/m2 IV	Docetaxel + Plinabulin (DP) n=274 participants at risk The treatment regimen for Docetaxel (D) will be followed for this arm. In addition, on Days 1 and 8 of the 21 day cycle, patients will receive Plinabulin (P) administered via IV infusion over 60 minutes. On Day 1, the infusion begins 2 hours from the starting time of docetaxel infusion, i.e, approximately 60 minutes from the end of docetaxel infusion. On Day 8, patients must be given an anti-emetic prophylactically before the plinabulin infusion. If emesis persists after Day 8, with a grade \>1, plinabulin will be reduced to 20 mg/m2. Patients from the DP Arm who stop treatment with docetaxel due to toxicity or another medically acceptable reason, may continue treatment with plinabulin alone as previously described. Docetaxel + Plinabulin (DP): Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2 Docetaxel (D): Docetaxel 75 mg/m2 IV
Blood and lymphatic system disorders Febrile neutropenia	5.4% 15/278 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).	3.3% 9/274 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).
Gastrointestinal disorders Ileus	0.00% 0/278 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).	4.0% 11/274 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).
Gastrointestinal disorders Diarrhoea	0.00% 0/278 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).	2.9% 8/274 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).
Gastrointestinal disorders Intestinal obstruction	0.00% 0/278 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).	2.2% 6/274 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).
General disorders Pyrexia	0.72% 2/278 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).	3.6% 10/274 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).
Infections and infestations Lung infection	9.0% 25/278 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).	3.6% 10/274 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).
Investigations Neutrophil count decreased	11.5% 32/278 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).	10.6% 29/274 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).
Investigations White blood cell count decreased	9.7% 27/278 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).	12.0% 33/274 • Up to 48 months Per protocol, deaths d/t disease progression were evaluated as efficacy outcomes, were not reported as AEs unless there's uncertainty about an AE. Consequently, deaths reported as SAEs are included in AEs tables. According to CT.gov reporting requirements for All-Cause Mortality, all deaths occurring during the cause of study, \& deaths d/t progression that were reported in clinical database death form, are entered in All-Cause Mortality table (Docetaxel=230 Plinabulin + Docetaxel =214deaths).

Other adverse events

Additional Information

Hao Zhang

BeyondSpring Pharmaceuticals, Inc.

Phone: (646) 305-6387

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place