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Completed

NCT Number: NCT02582125

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

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.

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Key information

Conditions

Advanced Non-Small Cell Lung Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Taichung Clinical Site 1, Taichung, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-4538

Drug

Primary outcomes

  1. Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG)

    Time frame: Approximately 6 months

Secondary outcomes

  1. Response rate (centrally assessed)

    Time frame: Approximately 6 months

  2. Response rate (study site assessment by investigator)

    Time frame: Approximately 6 months

  3. Overall survival

    Time frame: Approximately 1 year

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2015
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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