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ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

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

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

NCT02582125•Ono Pharmaceutical Co. Ltd

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (8)

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, Taiwan

Key Dates

Start Date

January 27, 2016

Primary Completion Date

January 4, 2021

Completion Date

December 31, 2021

Last Updated

March 24, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Non-small Cell Lung Cancer

Interventions

ONO-4538

DRUG

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

NCT06731413

Non-Small Cell Lung CancerNSCLC+2 more

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RECRUITING

Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC

NCT07356544

NSCLC (Advanced Non-small Cell Lung Cancer)HER2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC

Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation

A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

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A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer