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NCT02504489 · ClinicalTrials.gov registry record · Phase 3
Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by BeyondSpring Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 559
- Enrollment target
- 20
- Study locations
NCT02504489 is a Phase 3 study of Non-Small Cell Lung Cancer that has completed, run by BeyondSpring Pharmaceuticals. The registered enrollment target is 559 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT02504489, a Phase 3 study of Non-Small Cell Lung Cancer, has completed, sponsored by BeyondSpring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 559 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Docetaxel + Plinabulin (DP)
- DRUG Docetaxel (D)
Study Locations (20)
California
- Pacific Cancer Medical Center, Inc. - Anaheim
- Innovative Clinical Research Institute - Whittier
Illinois
- Orchard Healthcare Research Inc. - Skokie
- Carle Cancer Center - Urbana
Michigan
- Henry Ford Hospital - Detroit
- Michigan Center of Medical Research - Farmington Hills
Ohio
- University of Cincinnati - Cincinnati
- Toledo Cancer Center - Toledo
Arizona
- Ironwood Cancer & Research Centers - Chandler
Colorado
- Memorial Health Care System - Colorado Springs
Connecticut
- Cancer Center of Central Connecticut - Plainville
Georgia
- Peachtree Hematoloy-Oncology Consultants, PC - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 559 participants |
| Start Date | 2015-12 |
| Est. Completion | 2021-05-23 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02504489
The ClinicalTrials.gov registry entry for NCT02504489 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 559 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (15% lower). The listed sponsor is BeyondSpring Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Docetaxel + Plinabulin (DP) is the first listed.
NCT02504489 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Illinois, Michigan.
Frequently Asked Questions
What is clinical trial NCT02504489 about?
NCT02504489 is a clinical study titled "Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC". 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 ...
What is the current status of trial NCT02504489?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 559 participants. The study started on 2015-12. Estimated completion is 2021-05-23.
What conditions does trial NCT02504489 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT02504489?
The interventions under investigation include: Docetaxel + Plinabulin (DP) (DRUG), Docetaxel (D) (DRUG).
Who is sponsoring clinical trial NCT02504489?
This trial is sponsored by BeyondSpring Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02504489 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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