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ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer

Primary Purpose

Advanced Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
ONO-4538
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-small Cell Lung Cancer focused on measuring ONO-4538, Advanced non-small cell lung cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Current or prior severe hypersensitivity to another antibody product
  • Multiple primary cancers

Sites / Locations

  • Taichung Clinical Site 1
  • Taichung Clinical Site 2
  • Tainan Clinical Site 1
  • Tainan Clinical Site 2
  • Tainan Clinical Site 3
  • Taipei Clinical Site 1
  • Taipei Clinical Site 2
  • Taipei Clinical Site 3

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ONO-4538

Arm Description

ONO-4538 water-soluble injection, 100 mg/vial, 3 times once every 2 weeks in each 6-week cycle

Outcomes

Primary Outcome Measures

Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG)

Secondary Outcome Measures

Response rate (centrally assessed)
Response rate (study site assessment by investigator)
Overall survival

Full Information

First Posted
October 20, 2015
Last Updated
April 19, 2022
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02582125
Brief Title
ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer
Official Title
ONO-4538 Multicenter, Open-label, Single-arm, Phase II Study in Advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 27, 2016 (Actual)
Primary Completion Date
January 4, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-small Cell Lung Cancer
Keywords
ONO-4538, Advanced non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ONO-4538
Arm Type
Experimental
Arm Description
ONO-4538 water-soluble injection, 100 mg/vial, 3 times once every 2 weeks in each 6-week cycle
Intervention Type
Drug
Intervention Name(s)
ONO-4538
Primary Outcome Measure Information:
Title
Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG)
Time Frame
Approximately 6 months
Secondary Outcome Measure Information:
Title
Response rate (centrally assessed)
Time Frame
Approximately 6 months
Title
Response rate (study site assessment by investigator)
Time Frame
Approximately 6 months
Title
Overall survival
Time Frame
Approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Current or prior severe hypersensitivity to another antibody product Multiple primary cancers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ono Pharmaceutical Co., Ltd.
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Taichung Clinical Site 1
City
Taichung
Country
Taiwan
Facility Name
Taichung Clinical Site 2
City
Taichung
Country
Taiwan
Facility Name
Tainan Clinical Site 1
City
Tainan
Country
Taiwan
Facility Name
Tainan Clinical Site 2
City
Tainan
Country
Taiwan
Facility Name
Tainan Clinical Site 3
City
Tainan
Country
Taiwan
Facility Name
Taipei Clinical Site 1
City
Taipei
Country
Taiwan
Facility Name
Taipei Clinical Site 2
City
Taipei
Country
Taiwan
Facility Name
Taipei Clinical Site 3
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32094063
Citation
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.
Results Reference
derived

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ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer

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