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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Lung<br/>CancersCancer LocationLung
Cancers

Systemic therapy | LungLung,Non-Small Cell Lung Cancer

Trial Overview Read MoreRead more

This phase III trial is comparing outcomes for patients with Non-Small Cell (NSC) Lung Cancer, who are receiving second- or third- line chemotherapy with docetaxel alone and in combination with plinabulin, for advanced stage or metastatic disease.
 

This trial is treating patients with Non-Small Cell (NSC) Lung Cancer .

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

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

Commercial Sponsor

BeyondSpring Pharmaceuticals, Inc.

Summary

The primary purpose of the study is to compare the overall survival of NSCLC patients receiving second- or third-line chemotherapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D Arm) for advanced or metastatic disease. Secondary purposes of the study are: 1.To compare the neutropenia (frequency, severity and clinical sequelae), duration of response, quality of life, response rate and progression free survival in patients with NSCLC treated with DP to patients treated with D as second- or third-line chemotherapy for advanced or metastatic disease; and 2.To compare the safety and adverse event profiles of DP to D respectively, as well as dose delays, dose modifications, and/or dose discontinuation of docetaxel due to safety concerns in the two treatment arms. 3.To evaluate population pharmacokinetics in patients enrolled in China and western countries (US and Australia).

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

Epworth Hospital
Richmond
Ms Felicity Osmond
felicity.osmond@epworth.org.au
03 9936 8055

Barwon Health, University Hospital Geelong
Geelong
Dr Lea-Anne Harrison
leaanne.harrison@barwonhealth.org.au
03 42 15 2758

Peninsula & South Eastern Haematology and Oncology Group
Frankston
Mr Albert Goikman
ag@paso.com.au
03 9771 8918

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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