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

October 21, 2024 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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONO-4538 for squamous non-small-cell lung cancer (NSCLC)
In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase.
Drug: ONO-4538
ONO-4538 Study in Patients With Squamous NSCLC
Other Names:
  • nivolumab
Drug: ONO-4538
ONO-4538 Study in Patients With Non-Squamous NSCLC
Other Names:
  • nivolumab
Experimental: ONO-4538 for non-squamous non-small-cell lung cancer (NSCLC)
In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase.
Drug: ONO-4538
ONO-4538 Study in Patients With Squamous NSCLC
Other Names:
  • nivolumab
Drug: ONO-4538
ONO-4538 Study in Patients With Non-Squamous NSCLC
Other Names:
  • nivolumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (Centrally Assessed)
Time Frame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.
Response rate (%) = (Number of subjects whose confirmed best overall response was complete response (CR) or partial response (PR) / Total number of FAS)*100. 95% Confidence interval (CI) was calculated by Wilson method.
Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (Investigator-assessed)
Time Frame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.
Overall Survival
Time Frame: Follow-up phase: Every 6 months after the first day of treatment of the last subject enrolled in the study, until death or study completion.
Overall survival (days) = (the date of death due to any cause) - (the first dose date of investigational product) + 1. 95% CI was calculated by Kaplan-Meier method.
Follow-up phase: Every 6 months after the first day of treatment of the last subject enrolled in the study, until death or study completion.
Progression Free Survival (Centrally Assessed)
Time Frame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or until central PD was confirmed or data cut-off point.Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.
Progression free survival (days) = (the earlier date of the first documented progressive disease (PD) or death due to any cause) - (the first dose date of investigational product) + 1. 95% CI was calculated by Kaplan-Meier method.
Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or until central PD was confirmed or data cut-off point.Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.
Duration of Response (Centrally Assessed)
Time Frame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase(up to approximately 10 months).Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Duration of response (days) = (the date of the first documented PD or death due to any cause after response was confirmed) - (the date of the first confirmed CR or PR) + 1. Median (95% CI) was calculated by Kaplan-Meier method.
Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase(up to approximately 10 months).Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.

Collaborators and Investigators

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

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Mitsunobu Tanimoto, 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 (Estimated)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

December 9, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

April 1, 2024

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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