ONO-4538 Study in Patients With Advanced Non-Small Cell L... | NCT02582125

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

NCT02582125

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Mar 24, 2025Actual

Enrollment

53Actual

Phase

Phase 2

Conditions

Advanced Non-small Cell Lung Cancer

Interventions

ONO-4538

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 27, 2016Actual

Primary Completion Date

Jan 4, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Oct 20, 2015

First Submission Date that Met QC Criteria

Oct 20, 2015

First Posted Date

Oct 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2025

Last Update Posted Date

Mar 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ONO-4538	Experimental	ONO-4538 water-soluble injection, 100 mg/vial, 3 times once every 2 weeks in each 6-week cycle	Drug: ONO-4538

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ONO-4538	Drug		ONO-4538

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG)		Approximately 6 months

Secondary Outcomes

Measure	Description	Time Frame
Response rate (centrally assessed)		Approximately 6 months
Response rate (study site assessment by investigator)		Approximately 6 months
Overall survival

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ono Pharmaceutical Co., Ltd.	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taichung Clinical Site 1		Taichung			Taiwan
Taichung Clinical Site 2

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32094063	Derived	Chen YM, Chih-Hsin Yang J, Su WC, Chong IW, Hsia TC, Lin MC, Chang GC, Chiu CH, Ho CC, Wu SY, Hung JY, Wang CC, Yang TY, Yu CJ. Nivolumab safety and efficacy in advanced, platinum-resistant, non-small cell lung cancer, radical radiotherapy-ineligible patients: A phase II study in Taiwan. J Formos Med Assoc. 2020 Dec;119(12):1817-1826. doi: 10.1016/j.jfma.2020.01.004. Epub 2020 Feb 22.

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins