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Trial · NCT07361484

Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy and Platinum Chemotherapy (DUBLIN-4)

NCT07361484, Phase 3, Not yet recruiting, BeyondSpring Pharmaceuticals Inc.

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy and Platinum Chemotherapy (DUBLIN-4). Trials, record NCT07361484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07361484

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy and Platinum Chemotherapy (DUBLIN-4)
NCT number
NCT07361484
Status
Not yet recruiting
Phases
Phase 3
Enrollment
442 participants, estimated
Lead sponsor
BeyondSpring Pharmaceuticals Inc.
Conditions
Non-Small Cell Lung Cancer, Non-squamous Non-Small Cell Lung Cance
Interventions
Plinabulin, Docetaxel, Placebo (matching plinabulin placebo)
First posted
2026-01-23
Last updated
2026-09-29

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryOverall Survival (OS)Approximately 2 years after study initiation.OS is defined as the time from randomization to death from any cause
SecondaryProgression-Free Survival (PFS)Approximately 2 years after study initiation.Time from randomization to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
SecondaryObjective Response Rate (ORR)Approximately 2 years after study initiation.Proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1.
SecondaryIncidence of Grade 4 Neutropenia (Cycle 1 Day 8 ANC)At Day 8 of Cycle 1 (approximately 1 week after the first dose; each treatment cycle is 21 days).Proportion of participants with Grade 4 neutropenia, defined as absolute neutrophil count (ANC) \<0.5 × 10\^9/L, based on ANC on Day 8 of Cycle 1.
SecondaryOverall Survival (OS) Rate at Month 2424 months after randomization.Proportion of participants alive at 24 months after randomization.
SecondaryOverall Survival (OS) Rate at Month 3636 months after randomization.Proportion of participants alive at 36 months after randomization.
SecondaryDuration of Response (DoR)Approximately 2 years after study initiation.Time from first documented CR or PR (whichever occurs first) until disease progression per RECIST v1.1 or death from any cause.
SecondaryDisease Control Rate (DCR)Approximately 2 years after study initiation.Proportion of participants with CR, PR, or stable disease (SD) lasting ≥6 months per RECIST v1.1.
SecondaryIncidence of New Brain MetastasesApproximately 2 years after study initiation.Incidence of new brain metastases based on brain imaging (MRI or head CT).
SecondaryQuality of Life (QoL) - EORTC QLQ-LC13Approximately 2 years after study initiation.
Change from baseline in EORTC QLQ-LC13 scores. Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13). Scores are transformed to a 0 to 100 scale. Higher scores indicate worse symptoms / greater symptom burden (worse outcome).

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07361484

GET https://conductscience.org/api/trials/v1/NCT07361484/registered