CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 104 enrolled
Drug / intervention
ONO-4538 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02175017
NCT02175017Phase 2Completed
CompareCT.gov

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

Ono Pharmaceutical Co., Ltd.·interventional·Posted Jun 26, 2014·Updated Dec 9, 2024

In Brief

A Phase 2 clinical trial evaluating ONO-4538 for Advanced Non-small Cell Lung Cancer (NSCLC). Completed, enrolled 104 participants across 10 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Non-small Cell Lung Cancer (NSCLC)
CountriesSouth Korea
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 26, 2014
Enrollment StartJun 1, 2014
Primary CompletionNov 1, 2015
Study CompletionFeb 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.0 years ago

Interventions

ONO-4538drug

ONO-4538 Study in Patients With Squamous NSCLC

ONO-4538drug

ONO-4538 Study in Patients With Non-Squamous NSCLC