ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer
ONO-4538 Multicenter, Open-label, Single-arm, Phase II Study in Advanced Non-small Cell Lung Cancer
1 other identifier
interventional
53
1 country
8
Brief Summary
The objective of the study is to investigate the safety and efficacy of ONO-4538 in subjects with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2016
Longer than P75 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedStudy Start
First participant enrolled
January 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 24, 2025
May 1, 2024
4.9 years
October 20, 2015
March 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG)
Approximately 6 months
Secondary Outcomes (3)
Response rate (centrally assessed)
Approximately 6 months
Response rate (study site assessment by investigator)
Approximately 6 months
Overall survival
Approximately 1 year
Study Arms (1)
ONO-4538
EXPERIMENTALONO-4538 water-soluble injection, 100 mg/vial, 3 times once every 2 weeks in each 6-week cycle
Interventions
Eligibility Criteria
You may qualify if:
- Male or female ≥ 20 years of age
- Histologically or cytologically confirmed non-small cell lung cancer
- Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC
- Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1)
You may not qualify if:
- Current or prior severe hypersensitivity to another antibody product
- Multiple primary cancers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Taichung Clinical Site 1
Taichung, Taiwan
Taichung Clinical Site 2
Taichung, Taiwan
Tainan Clinical Site 1
Tainan, Taiwan
Tainan Clinical Site 2
Tainan, Taiwan
Tainan Clinical Site 3
Tainan, Taiwan
Taipei Clinical Site 1
Taipei, Taiwan
Taipei Clinical Site 2
Taipei, Taiwan
Taipei Clinical Site 3
Taipei, Taiwan
Related Publications (1)
Chen YM, Chih-Hsin Yang J, Su WC, Chong IW, Hsia TC, Lin MC, Chang GC, Chiu CH, Ho CC, Wu SY, Hung JY, Wang CC, Yang TY, Yu CJ. Nivolumab safety and efficacy in advanced, platinum-resistant, non-small cell lung cancer, radical radiotherapy-ineligible patients: A phase II study in Taiwan. J Formos Med Assoc. 2020 Dec;119(12):1817-1826. doi: 10.1016/j.jfma.2020.01.004. Epub 2020 Feb 22.
PMID: 32094063DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ono Pharmaceutical Co., Ltd.
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2015
First Posted
October 21, 2015
Study Start
January 27, 2016
Primary Completion
January 4, 2021
Study Completion
December 31, 2021
Last Updated
March 24, 2025
Record last verified: 2024-05