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Nivolumab+ Plinabulin

Phase 1

Non-small Cell Lung Cancer Metastatic | Small molecule | Oncology |BeyondSpring, Inc.|Last Updated: Nov 12, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Nivolumab+ Plinabulin · 1 trial · 1 indication

Phase 1 1
NCT02812667Nivolumab in Combination With Plinabulin in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)Non-small Cell Lung Cancer Metastatic
COMPLETED18 Analytics
PHASE1COMPLETED
Nivolumab in Combination With Plinabulin in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer MetastaticUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose (MTD)
2 years
Frequency and severity of treatment-related adverse events as assessed by CTCAE v4.
2 years

Secondary Endpoints

Objective response rate (ORR)
2 years
Disease control rate (DCR)
2 years
Progression free survival (PFS)
2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Nivolumab + PlinabulinEXPERIMENTALNivolumab 240mg IV, day 1 and 15 until disease progression Plinabulin 3.5mg/m2, 20mg/m2, 30 mg/m2 or 40mg/m2 IV, day 1,8 and 15 until disease progression

Interventions

NameTypeDescription
Nivolumab + PlinabulinDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects with histologically or cytologically-confirmed metastatic NSCLC whose disease progressed during/after treatment with at least one platinum-containing chemotherapy regimen. * At least 1 prior systemic therapy for metastatic disease. Adjuvant chemotherapy or concurrent ...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Non-small Cell Lung Cancer Metastatic")

Frequently asked questions about Nivolumab+ Plinabulin

What is Nivolumab used for in Non-small Cell Lung Cancer Metastatic?

Nivolumab is used for Non-small Cell Lung Cancer Metastatic and Lung Cancer. It is being studied in combination with other agents. In a completed Phase 1 trial, Nivolumab was combined with Plinabulin in patients with metastatic Non-small Cell Lung Cancer. The trial enrolled 18 participants in the United States.

Who makes Nivolumab?

Nivolumab is developed by BeyondSpring, Inc., a company traded under the ticker BYSI. The drug is being investigated in oncology, specifically for Non-small Cell Lung Cancer Metastatic and Lung Cancer. BeyondSpring is conducting clinical trials to evaluate Nivolumab in combination with other therapies.

What phase is Nivolumab in?

Nivolumab is in Phase 1 clinical development. It is an investigational drug, not yet approved. Two Phase 1 trials have been completed, one in metastatic Non-small Cell Lung Cancer and another in recurrent Small Cell Lung Cancer. Both trials were conducted in the United States.

What clinical trials is Nivolumab in?

Nivolumab has been studied in two completed Phase 1 trials. NCT02812667 evaluated Nivolumab with Plinabulin in metastatic Non-small Cell Lung Cancer, enrolling 18 patients. NCT03575793 studied Nivolumab, Ipilimumab, and Plinabulin in recurrent Small Cell Lung Cancer, enrolling 39 patients. Both trials were in the United States.

Is Nivolumab the same as Plinabulin?

No, Nivolumab is not the same as Plinabulin. Nivolumab is the drug being developed by BeyondSpring, Inc. Plinabulin is a separate agent used in combination with Nivolumab in clinical trials. The trials combine Nivolumab with Plinabulin, sometimes with Ipilimumab, to treat lung cancers.