8 completed, 2 active not recruiting, 2 terminated, 1 not yet recruiting. 9 Phase 2, 6 Phase 1, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 4, Active not recruiting 2, Terminated 2, Recruiting 1 |
| Phase 1 | 6 | Completed 4, Terminated 2 |
| Phase 3 | 4 | Completed 2, Not yet recruiting 1, Unknown 1 |
Follow NPI 2358: new trials by email Literature Review of NPI 2358 trials Research Report on NPI 2358
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy and Platinum Chemotherapy (DUBLIN-4) Plinabulin, Docetaxel, Placebo (matching plinabulin placebo) - Non-Small Cell Lung Cancer, Non-squamous Non-Small Cell Lung Cance | Phase 3 | Not yet recruiting | BeyondSpring Pharmaceuticals Inc. | 442 | 2026-12-01 | 2026-09-29 |
| First Line Pembrolizumab, Plinabulin Plus Etoposide and Platinum (EP) for ES-SCLC Pembrolizumab, Plinabulin plus Etoposide and Platinum - Small Cell Lung Cancer Extensive Stage | Phase 2 | Recruiting | Xiaorong Dong | 45 | 2024-03-07 | 2025-02-11 |
| Pembrolizumab in Combination With Plinabulin and Docetaxel For Metastatic NSCLC After ICIs (KeyPemls-004) Pembrolizumab in Combination with Plinabulin and Docetaxel - Non Small Cell Lung Cancer Metastatic | Phase 2 | Active not recruiting | Peking Union Medical College Hospital | 47 | 2023-02-01 | 2026-07-28 |
| Study of Plinabulin and Pegfilgrastim in People With Multiple Myeloma Undergoing an Autologous Hematopoietic Stem Cell Transplant (AHCT) Plinabulin - Multiple Myeloma | Phase 2 | Active not recruiting | Memorial Sloan Kettering Cancer Center | 17 | 2021-12-21 | 2025-12-24 |
| Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies Atezolizumab, Avelumab, Durvalumab - Advanced Bladder Carcinoma, Advanced Lung Non-Small Cell Carcinoma | Phase 1 / Phase 2 | Terminated | M.D. Anderson Cancer Center | 19 | 2021-04-14 | 2026-04-30 |
| Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia Pegfilgrastim, Plinabulin, D5W Placebo - Chemotherapy-induced Neutropenia | Phase 3 | Unknown | BeyondSpring Pharmaceuticals Inc. | 221 | 2019-10-23 | 2021-01-15 |
| A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Nivolumab, Plinabulin, Ipilimumab - Lung Cancer, SCLC | Phase 1 / Phase 2 | Completed | Salma Sabbour | 39 | 2018-09-06 | 2026-01-20 |
| Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3 Plinabulin, Pegfilgrastim, Saline Placebo - Chemotherapy-induced Neutropenia | Phase 3 | Completed | BeyondSpring Pharmaceuticals Inc. | 105 | 2018-05-29 | 2024-08-29 |
| Plinabulin iv Solution in Prevention of TAC Induced Neutropenia Plinabulin, Pegfilgrastim, Docetaxel, doxorubicin, and cyclophosphamide (TAC) - Chemotherapy-induced Neutropenia | Phase 2 | Completed | BeyondSpring Pharmaceuticals Inc. | 115 | 2017-11-27 | 2020-01-18 |
| Nivolumab and Plinabulin in Treating Patients With Stage IIIB-IV, Recurrent, or Metastatic Non-small Cell Lung Cancer Nivolumab, Plinabulin - ALK Gene Translocation, EGFR Activating Mutation | Phase 1 / Phase 2 | Terminated | University of Washington | 5 | 2017-06-14 | 2019-03-04 |
| Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2 Plinabulin, Pegfilgrastim - Chemotherapy-induced Neutropenia | Phase 2 | Completed | BeyondSpring Pharmaceuticals Inc. | 55 | 2017-04-05 | 2024-05-16 |
| Nivolumab in Combination With Plinabulin in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Nivolumab + Plinabulin - Non-small Cell Lung Cancer Metastatic | Phase 1 | Completed | Lyudmila Bazhenova, M.D. | 18 | 2016-08-29 | 2025-11-12 |
| Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC Docetaxel + Plinabulin (DP), Docetaxel (D) - Non-Small Cell Lung Cancer | Phase 3 | Completed | BeyondSpring Pharmaceuticals Inc. | 559 | 2015-12-01 | 2026-05-19 |
| Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer docetaxel, NPI-2358 + docetaxel - Cancer | Phase 1 / Phase 2 | Completed | Nereus Pharmaceuticals, Inc. | 172 | 2008-02-01 | 2011-08-16 |
| Study of the Vascular Disrupting Agent NPI-2358 in Patients With Advanced Solid Tumors or Lymphoma NPI-2358 - Cancer | Phase 1 | Completed | Nereus Pharmaceuticals, Inc. | 35 | 2006-04-01 | 2011-01-10 |
Carcinoma, Non-Small-Cell Lung (5) · Neoplasms (3) · Lung Neoplasms (2) · Carcinoma, Renal Cell (1) · Lymphoma (1) · Multiple Myeloma (1) · Neoplasm Metastasis (1) · Urinary Bladder Neoplasms (1)
BeyondSpring Pharmaceuticals Inc. (6) · Nereus Pharmaceuticals, Inc. (2) · Lyudmila Bazhenova, M.D. (1) · M.D. Anderson Cancer Center (1) · Memorial Sloan Kettering Cancer Center (1) · Peking Union Medical College Hospital (1) · Salma Sabbour (1) · University of Washington (1) · Xiaorong Dong (1)
United States (10) · China (7) · Ukraine (4) · Australia (2) · Russia (2) · Argentina (1) · Brazil (1) · Chile (1) · India (1)
Douglas Blayney, M.D. (1) · Douglas W. Blayney, MD (1) · Gunjan Shah, MD, MS (1) · Lyudmilla Bazhenova, MD (1) · Matthew A Spear, M.D. (1) · Matthew A Spear, MD (1) · Rafael Santana-Davila (1) · Salma Jabbour, MD (1) · Siqing Fu, MD, PHD (1)
PMID 32970104, PMID 35084480, PMID 39173229, PMID 39265599, PMID 40580957
P30CA015704 (1)