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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-27

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ONO-4538

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

Group Type EXPERIMENTAL

ONO-4538

Intervention Type DRUG

Interventions

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ONO-4538

Intervention Type DRUG

Eligibility Criteria

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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)