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

Ono Pharmaceutical Co. Ltd8 sites in 1 country53 target enrollmentJanuary 27, 2016

ConditionsAdvanced Non-small Cell Lung Cancer

InterventionsONO-4538

DrugsONO-4538

Overview

Phase: Phase 2
Intervention: ONO-4538
Conditions: Advanced Non-small Cell Lung Cancer
Sponsor: Ono Pharmaceutical Co. Ltd
Enrollment: 53
Locations: 8
Primary Endpoint: Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 27, 2016

End Date

December 31, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ono Pharmaceutical Co. Ltd

Responsible Party

Sponsor

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)