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

NCT ID: NCT02175017

Last Updated: 2024-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2021-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Non-small Cell Lung Cancer (NSCLC)

Keywords

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ONO-4538 Advanced non-small cell lung cancer (NSCLC) nivolumab

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ONO-4538

Intervention Type DRUG

ONO-4538 Study in Patients With Squamous NSCLC

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.

Group Type EXPERIMENTAL

ONO-4538

Intervention Type DRUG

ONO-4538 Study in Patients With Non-Squamous NSCLC

Interventions

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ONO-4538

ONO-4538 Study in Patients With Squamous NSCLC

Intervention Type DRUG

ONO-4538

ONO-4538 Study in Patients With Non-Squamous NSCLC

Intervention Type DRUG

Other Intervention Names

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nivolumab nivolumab

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitsunobu Tanimoto

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Goyang-si Clinical Site 103

Goyang-si, Gyeonggi-do, South Korea

Site Status

Seongnam-si Clinical Site 104

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Cheongju-si Clinical Site 106

Cheongju-si, North Chungcheong, South Korea

Site Status

Incheon Clinical Site 102

Incheon, , South Korea

Site Status

Seoul Clinical Site 101

Seoul, , South Korea

Site Status

Seoul Clinical Site 107

Seoul, , South Korea

Site Status

Seoul Clinical Site 108

Seoul, , South Korea

Site Status

Seoul Clinical Site 109

Seoul, , South Korea

Site Status

Seoul Clinical Site 110

Seoul, , South Korea

Site Status

Ulsan Clinical Site 105

Ulsan, , South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ONO-4538-09

Identifier Type: -

Identifier Source: org_study_id