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NCT02582125 Clinical Trial

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

Advanced Non-small Cell Lung Cancer Clinical Trial

Official title:
ONO-4538 Multicenter, Open-label, Single-arm, Phase II Study in Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02582125
Other study ID # ONO-4538-25
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 27, 2016
Est. completion date December 31, 2021

Study information
Verified date April 2022
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date December 31, 2021
Est. primary completion date January 4, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-4538

Locations
Country Name City State
Taiwan Taichung Clinical Site 1 Taichung
Taiwan Taichung Clinical Site 2 Taichung
Taiwan Tainan Clinical Site 1 Tainan
Taiwan Tainan Clinical Site 2 Tainan
Taiwan Tainan Clinical Site 3 Tainan
Taiwan Taipei Clinical Site 1 Taipei
Taiwan Taipei Clinical Site 2 Taipei
Taiwan Taipei Clinical Site 3 Taipei

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG) Approximately 6 months
Secondary Response rate (centrally assessed) Approximately 6 months
Secondary Response rate (study site assessment by investigator) Approximately 6 months
Secondary Overall survival Approximately 1 year
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