Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC
Public ClinicalTrials.gov record NCT02504489. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02504489
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 559 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2015 (Actual)
- Primary completion
- Jul 21, 2021 (Actual)
- Completion
- Oct 30, 2023 (Actual)
- Last update posted
- May 19, 2026
2015 – 2023
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer & Research Centers | Chandler | Arizona | 85224 | — |
| Pacific Cancer Medical Center, Inc. | Anaheim | California | 92801 | — |
| Innovative Clinical Research Institute | Whittier | California | 90603 | — |
| Memorial Health Care System | Colorado Springs | Colorado | 80909 | — |
| Cancer Center of Central Connecticut | Plainville | Connecticut | 06062 | — |
| Peachtree Hematoloy-Oncology Consultants, PC | Atlanta | Georgia | 30318 | — |
| Orchard Healthcare Research Inc. | Skokie | Illinois | 60077 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Kansas University Medical Center | Westwood | Kansas | 00913 | — |
| University of Louisville-Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Michigan Center of Medical Research | Farmington Hills | Michigan | 48334 | — |
| Hattiesburg Clinic Hematology/Oncology | Hattiesburg | Mississippi | 39401 | — |
| Central Care Cancer Center | Bolivar | Missouri | 65613 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Toledo Cancer Center | Toledo | Ohio | 43623 | — |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | — |
| Cookeville Regional Medical Center Cancer Center | Cookeville | Tennessee | 61801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02504489, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 19, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02504489 live on ClinicalTrials.gov.