Multiple clinical trials spanning Phase 1 through Phase 3 have evaluated Plinabulin as monotherapy and in combination with chemotherapy or immunotherapy for advanced non-small cell lung cancer, chemotherapy-induced neutropenia, small cell lung cancer, melanoma, and solid tumors. Sponsored by pharmaceutical entities like BeyondSpring and Nereus as well as academic centers including M.D. Anderson, Peking Union Medical College Hospital, and the National Cancer Institute, these studies display active, recruiting, completed, and terminated statuses. Notable late-phase evaluations focus on neutropenia prevention and advanced lung malignancies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07361484 | NOT_YET_RECRUITING | Non-Small Cell Lung Cancer; Non-squamous Non-Small Cell Lung Cance |
BeyondSpring Pharmaceuticals Inc. |
2026-06-01 | PHASE3 |
| NCT05130827 | ACTIVE_NOT_RECRUITING | Multiple Myeloma |
Memorial Sloan Kettering Cancer Center |
2021-12-21 | PHASE2 |
| NCT05745350 | RECRUITING | Small Cell Lung Cancer Extensive Stage |
Xiaorong Dong |
2024-03-07 | PHASE2 |
| NCT05599789 | ACTIVE_NOT_RECRUITING | Non Small Cell Lung Cancer Metastatic |
Peking Union Medical College Hospital |
2023-02-01 | PHASE2 |
| NCT04902040 | TERMINATED | Advanced Bladder Carcinoma; Advanced Lung Non-Small Cell Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Melanoma; Advanced Merkel Cell Carcinoma; Advanced Renal Cell Carcinoma; Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage III Merkel Cell Carcinoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Clinical Stage IV Merkel Cell Carcinoma AJCC v8; Pathologic Stage III Cutaneous Melanoma AJCC v8; Pathologic Stage III Merkel Cell Carcinoma AJCC v8; Pathologic Stage IIIA Cutaneous Melanoma AJCC v8; Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8; Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Pathologic Stage IIIB Merkel Cell Carcinoma AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Pathologic Stage IIID Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8; Pathologic Stage IV Merkel Cell Carcinoma AJCC v8; Stage III Bladder Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage III Renal Cell Cancer AJCC v8; Stage IIIA Bladder Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Bladder Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Bladder Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8; Stage IVA Bladder Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Bladder Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8 |
M.D. Anderson Cancer Center |
2021-04-14 | PHASE1; PHASE2 |
| NCT02812667 | COMPLETED | Non-small Cell Lung Cancer Metastatic |
Lyudmila Bazhenova, M.D. |
2016-08-29 | PHASE1 |
| NCT03575793 | COMPLETED | Lung Cancer; SCLC |
Salma Sabbour |
2018-09-06 | PHASE1; PHASE2 |
| NCT02504489 | COMPLETED | Non-Small Cell Lung Cancer |
BeyondSpring Pharmaceuticals Inc. |
2015-12 | PHASE3 |
| NCT03294577 | UNKNOWN | Chemotherapy-induced Neutropenia |
BeyondSpring Pharmaceuticals Inc. |
2019-10-23 | PHASE3 |
| NCT03102606 | COMPLETED | Chemotherapy-induced Neutropenia |
BeyondSpring Pharmaceuticals Inc. |
2018-05-29 | PHASE3 |
| NCT04227990 | COMPLETED | Chemotherapy-induced Neutropenia |
BeyondSpring Pharmaceuticals Inc. |
2017-11-27 | PHASE2 |
| NCT02846792 | TERMINATED | ALK Gene Translocation; EGFR Activating Mutation; Recurrent Non-Small Cell Lung Carcinoma; ROS1 Gene Translocation; Stage IIIB Non-Small Cell Lung Cancer AJCC v7; Stage IV Non-Small Cell Lung Cancer AJCC v7 |
University of Washington |
2017-06-14 | PHASE1; PHASE2 |
| NCT04345900 | COMPLETED | Chemotherapy-induced Neutropenia |
BeyondSpring Pharmaceuticals Inc. |
2017-04-05 | PHASE2 |
| NCT02846792 | Terminated | ALK Gene Translocation|EGFR Activating Mutation|Recurrent Non-Small Cell Lung Carcinoma|ROS1 Gene Translocation|Stage IIIB Non-Small Cell Lung Cancer AJCC v7|Stage IV Non-Small Cell Lung Cancer AJCC v7 |
University of Washington|National Cancer Institute (NCI) |
2017-06-14 | Phase 1|Phase 2 |
| NCT00630110 | COMPLETED | Cancer |
Nereus Pharmaceuticals, Inc. |
2008-02 | PHASE1; PHASE2 |
| NCT00322608 | COMPLETED | Cancer |
Nereus Pharmaceuticals, Inc. |
2006-04 | PHASE1 |
| NCT00630110 | Completed | Cancer |
Nereus Pharmaceuticals Inc. |
2008-02 | Phase 1|Phase 2 |
(data from https://clinicaltrials.gov, updated on 2026-01-23)
Check the
Plinabulin
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.