NCT02504489: DUBLIN-3

Randomized Blinded Phase III Assessment of Second or Third-Line Chemotherapy With Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced Non-Small Cell Lung Cancer and With at Least One Measurable Lung Lesion

Completed Phase 3 Results posted Last updated 16 May 2026

What this trial tests

Phase 3 trial testing Docetaxel + Plinabulin (DP) in Non-Small Cell Lung Cancer in 559 participants. Completed in 30 October 2023.

Timeline

1 December 2015

Primary endpoint
21 July 2021

30 October 2023

Quick facts

Lead sponsor	BeyondSpring Pharmaceuticals Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	559
Start date	1 December 2015
Primary completion	21 July 2021
Estimated completion	30 October 2023
Sites	57 locations across United States, Australia, China

Drugs / interventions tested

• Docetaxel + Plinabulin (DP) — full drug profile →
• Docetaxel (D) — full drug profile →

Conditions studied

• Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

BeyondSpring Pharmaceuticals Inc. — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Overall Survival
  Time frame: The time (Days) from the date of randomization to the date of death, up to 48 months
  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).

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The evolution and heterogeneity of neutrophils in cancers: origins, subsets, functions, orchestrations and clinical applications.
   Liu S, Wu W, Du Y, Yin H, et al · · 2023 · cited 66× · PMID 37679744 · DOI 10.1186/s12943-023-01843-6
2. Structures and Biological Activities of Diketopiperazines from Marine Organisms: A Review.
   Song Z, Hou Y, Yang Q, Li X, et al · · 2021 · cited 52× · PMID 34436242 · DOI 10.3390/md19080403
3. Plinabulin, a Distinct Microtubule-Targeting Chemotherapy, Promotes M1-Like Macrophage Polarization and Anti-tumor Immunity.
   Natoli M, Herzig P, Pishali Bejestani E, Buchi M, et al · · 2021 · cited 35× · PMID 33747968 · DOI 10.3389/fonc.2021.644608
4. Development of Immunotherapy Strategies Targeting Tumor Microenvironment Is Fiercely Ongoing.
   Bai R, Cui J. · · 2022 · cited 32× · PMID 35833121 · DOI 10.3389/fimmu.2022.890166
5. The impact of myelosuppression on quality of life of patients treated with chemotherapy.
   Crawford J, Herndon D, Gmitter K, Weiss J. · · 2024 · cited 31× · PMID 38587388 · DOI 10.2217/fon-2023-0513
6. From Seabed to Bedside: A Review on Promising Marine Anticancer Compounds.
   Wang E, Sorolla MA, Krishnan PDG, Sorolla A. · · 2020 · cited 31× · PMID 32041255 · DOI 10.3390/biom10020248
7. Plinabulin, an inhibitor of tubulin polymerization, targets KRAS signaling through disruption of endosomal recycling.
   Cimino PJ, Huang L, Du L, Wu Y, et al · · 2019 · cited 28× · PMID 30972217 · DOI 10.3892/br.2019.1196
8. 34th Annual Meeting & Pre-Conference Programs of the Society for Immunotherapy of Cancer (SITC 2019): part 1 : National Harbor, MD, USA. 6-10 November 2019.
   · 2019 · cited 19× · PMID 31694725 · DOI 10.1186/s40425-019-0763-1