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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
Korea, Republic of
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:

  1. Male or female ≥ 20 years of age
  2. Histologically or cytologically confirmed non-small cell lung cancer
  3. Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC
  4. Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1)

Exclusion Criteria:

  1. Current or prior severe hypersensitivity to another antibody product
  2. Multiple primary cancers

Sites / Locations

  • Cheongju-si Clinical Site 106
  • Goyang-si Clinical Site 103
  • Seongnam-si Clinical Site 104
  • Incheon Clinical Site 102
  • Seoul Clinical Site 101
  • Seoul Clinical Site 107
  • Seoul Clinical Site 108
  • Seoul Clinical Site 109
  • Seoul Clinical Site 110
  • Ulsan Clinical Site 105

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

Response rate (centrally assessed)

Secondary Outcome Measures

Response rate (study site assessment by investigator)
Overall survival
Progression free survival

Full Information

First Posted
June 18, 2014
Last Updated
March 19, 2021
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02175017
Brief Title
ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer
Official Title
ONO-4538 Multicenter, Open-label, Uncontrolled, Phase II Study in Advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
February 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 efficacy and safety 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
104 (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
Response rate (centrally assessed)
Time Frame
Approximately 6 months
Secondary Outcome Measure Information:
Title
Response rate (study site assessment by investigator)
Time Frame
Approximately 6 months
Title
Overall survival
Time Frame
Approximately 1 year
Title
Progression free survival
Time Frame
Approximately 6 months

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
Mitsunobu Tanimoto
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Cheongju-si Clinical Site 106
City
Cheongju-si
State/Province
Chungcheongbuk-do
Country
Korea, Republic of
Facility Name
Goyang-si Clinical Site 103
City
Goyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Seongnam-si Clinical Site 104
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Incheon Clinical Site 102
City
Incheon
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 101
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 107
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 108
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 109
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Clinical Site 110
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan Clinical Site 105
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing URL
https://www.ono.co.jp/eng/rd/policy.html

Learn more about this trial

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

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