CLINICAL TRIALS PROFILE FOR PLINABULIN

Clinical Trials for Plinabulin

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02504489 ↗	Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC	Active, not recruiting	BeyondSpring Pharmaceuticals Inc.	Phase 3	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.
NCT02812667 ↗	Nivolumab in Combination With Plinabulin in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)	Recruiting	BeyondSpring Pharmaceuticals Inc.	Phase 1	The purpose of the study is to determine whether plinabulin (also known as BPI-2358) has an effect on cancer and body in combination with nivolumab, a standard treatment for metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. Plinabulin inhibits tumor growth by targeting both new and existing blood vessels going to the tumor as well as killing tumor cells. Plinabulin is an investigational drug, a drug that is not approved for use outside of research studies by regulatory agencies. Up to 38 patients will be enrolled.
NCT02812667 ↗	Nivolumab in Combination With Plinabulin in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)	Recruiting	Lyudmila Bazhenova, M.D.	Phase 1	The purpose of the study is to determine whether plinabulin (also known as BPI-2358) has an effect on cancer and body in combination with nivolumab, a standard treatment for metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. Plinabulin inhibits tumor growth by targeting both new and existing blood vessels going to the tumor as well as killing tumor cells. Plinabulin is an investigational drug, a drug that is not approved for use outside of research studies by regulatory agencies. Up to 38 patients will be enrolled.
NCT02846792 ↗	Nivolumab and Plinabulin in Treating Patients With Stage IIIB-IV, Recurrent, or Metastatic Non-small Cell Lung Cancer	Terminated	National Cancer Institute (NCI)	Phase 1/Phase 2	This phase I/II trial studies the side effects and best dose of plinabulin when given together with nivolumab and to see how well they work in treating patients with stage IIIB-IV non-small cell lung cancer that has come back or spread to other places in the body. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as plinabulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab and plinabulin together may work better at treating patients with non-small cell lung cancer.

Clinical Trial Conditions for Plinabulin

Condition Name

Condition Name
Intervention	Trials
Chemotherapy-induced Neutropenia	4
Non-Small Cell Lung Cancer	2
Clinical Stage III Merkel Cell Carcinoma AJCC v8	1
Stage IIIB Non-Small Cell Lung Cancer AJCC v7	1

Condition MeSH

Condition MeSH
Intervention	Trials
Lung Neoplasms	7
Carcinoma, Non-Small-Cell Lung	6
Neutropenia	4
Small Cell Lung Carcinoma	2

Clinical Trial Locations for Plinabulin

Trials by Country

Trials by Country
Location	Trials
China	37
United States	34
Ukraine	4
Australia	4
Russian Federation	2

Trials by US State

Trials by US State
Location	Trials
Illinois	4
California	4
Florida	2
New York	2
Tennessee	2

Clinical Trial Progress for Plinabulin

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
PHASE3	1
Phase 3	3
Phase 2	5

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	3
Completed	3
Not yet recruiting	3

Clinical Trial Sponsors for Plinabulin

Sponsor Name

Sponsor Name
Sponsor	Trials
BeyondSpring Pharmaceuticals Inc.	9
Covance	1
ICON plc	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	13
Other	7
NIH	1