Overview

Indication/Target
Program
Stage
Trial Name / Collaborator
Plinabulin + Docetaxel
Study 103 (DUBLIN-3)

– OS, PFS, ORR benefit

Han et al., Lancet Resp Med 12(10): 775-786 (2024)

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Plinabulin alone or+ Pegfilgrastim
Studies 105 & 106

(PROTECTIVE-1 & PROTECTIVE-2)

Blayney et al. JAMA Oncol 6 (11): e204429 (2020)

Blayney et al. JAMA Network Open 5(1): e2145446 (2022)

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Click here to read more about Study 106

Plinabulin + Pembrolizumab + Docetaxel
Study 303
Plinabulin + Pembrolizumab + Etoposide/Platinum
Plinabulin + PD-1/PD L1 + Radiation
NCT04902040

Lin et al., Med 6(10):100752 (2025)

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Plinabulin + ADC with topoisomerase inhibitors (TOP1-ADC)

Late stage

Indication/Target
Program
Stage
Trial Name
Plinabulin + Docetaxel
Study 103 (DUBLIN-3)

Presented at ESMO Asia & NACLC 2025, ISLAC & ESMO 2024
Published in “LANCET Respiratory Medicine” – 2024

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Plinabulin + Docetaxel
Studies 105 & 106

(PROTECTIVE-1 & PROTECTIVE-2) JAMA Oncology 2020; JAMA Network 2022

Click here to read more about Study 105

Click here to read more about Study 106

Investigator Initiated Trials

Indication/Target
Program
Stage
Trial Name
Plinabulin + Pembrolizumab + Docetaxel
Study 303

Presented at ASCO & SITC 2025

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Plinabulin + Pembrolizumab + Etoposide and Platinum
Study 302

Planned

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<p><span style="font-weight: 400;">Planned</span></p>
<p><a href="https://clinicaltrials.gov/study/NCT05745350" target="_blank" rel="noopener">Click here to read more</a></p>
Plinabulin + PD-1/PDL1 + Radiation
NCT04902040

Published in Med (Cell Press) 2025, Presented at SITC 2024 and 2025

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Plinabulin + ADC with topoisomerase inhibitors (TOP1-ADC)

EAP

BeyondSpring supports efforts to provide rapid access to investigational drugs for patients diagnosed with a serious or life-threatening disease or condition with no current approved treatment options, who have exhausted approved treatment options, are underserved with currently available treatment or preventive options, and are not eligible for clinical trials. Such individual use of an unlicensed investigational drug is often called “compassionate use” or “expanded access” but may go by other names. Unlike the use of an investigational new drug in a clinical trial setting, the primary purposes of expanded access are to use the investigational drug for patient treatment purposes, rather than to gather data on safety, tolerability, and effectiveness.

It is important to remember that investigational medicinal products have not yet received regulatory approval; thus, their potential risks and benefits have not yet been established. Physicians and patients should consider all possible benefits and risks when seeking access to an investigational medicinal product. Physicians who receive a BeyondSpring investigational drug for their patient(s) through expanded access must comply with all applicable laws and regulations, contractual conditions, safety reporting required by regulatory agencies, and protection of intellectual property. Submit your queries to eap@beyondspringpharma.com.

Pursuant to the 21st Century Cures Act, the posting of this policy does not serve as a guarantee of access to any specific investigational drug for any individual patient. Any approval of expanded access to an investigational drug(s) must always comply with applicable country-specific laws and regulations. This policy is subject to change. BeyondSpring may revise this policy at any time and may establish different expanded access policies for each investigational drug under development.

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