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

March 19, 2021 updated by: Ono Pharmaceutical Co. Ltd

ONO-4538 Multicenter, Open-label, Uncontrolled, Phase II Study in Advanced Non-small Cell Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Incheon Clinical Site 102
      • Seoul, Korea, Republic of
        • Seoul Clinical Site 101
      • Seoul, Korea, Republic of
        • Seoul Clinical Site 107
      • Seoul, Korea, Republic of
        • Seoul Clinical Site 108
      • Seoul, Korea, Republic of
        • Seoul Clinical Site 109
      • Seoul, Korea, Republic of
        • Seoul Clinical Site 110
      • Ulsan, Korea, Republic of
        • Ulsan Clinical Site 105
    • Chungcheongbuk-do
      • Cheongju-si, Chungcheongbuk-do, Korea, Republic of
        • Cheongju-si Clinical Site 106
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of
        • Goyang-si Clinical Site 103
      • Seongnam-si, Gyeonggi-do, Korea, Republic of
        • Seongnam-si Clinical Site 104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONO-4538
ONO-4538 water-soluble injection, 100 mg/vial, 3 times once every 2 weeks in each 6-week cycle
Drug: ONO-4538

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate (centrally assessed)
Time Frame: Approximately 6 months
Approximately 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate (study site assessment by investigator)
Time Frame: Approximately 6 months
Approximately 6 months
Overall survival
Time Frame: Approximately 1 year
Approximately 1 year
Progression free survival
Time Frame: Approximately 6 months
Approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-4538-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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