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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02175017
Recruitment Status : Unknown
Verified April 2017 by Ono Pharmaceutical Co. Ltd.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2014
Last Update Posted : May 23, 2017
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Non-small Cell Lung Cancer Drug: ONO-4538 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ONO-4538 Multicenter, Open-label, Uncontrolled, Phase II Study in Advanced Non-small Cell Lung Cancer
Study Start Date : June 2014
Actual Primary Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ONO-4538
ONO-4538 water-soluble injection, 100 mg/vial, 3 times once every 2 weeks in each 6-week cycle
Drug: ONO-4538

Primary Outcome Measures :
  1. Response rate (centrally assessed) [ Time Frame: Approximately 6 months ]

Secondary Outcome Measures :
  1. Response rate (study site assessment by investigator) [ Time Frame: Approximately 6 months ]
  2. Overall survival [ Time Frame: Approximately 1 year ]
  3. Progression free survival [ Time Frame: Approximately 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female ≥ 20 years of age
  2. Histologically or cytologically confirmed non-small cell lung cancer
  3. Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC
  4. Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1)

Exclusion Criteria:

  1. Current or prior severe hypersensitivity to another antibody product
  2. Multiple primary cancers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02175017

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Korea, Republic of
Cheongju-si Clinical Site 106
Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Goyang-si Clinical Site 103
Goyang-si, Gyeonggi-do, Korea, Republic of
Seongnam-si Clinical Site 104
Seongnam-si, Gyeonggi-do, Korea, Republic of
Incheon Clinical Site 102
Incheon, Korea, Republic of
Seoul Clinical Site 101
Seoul, Korea, Republic of
Seoul Clinical Site 107
Seoul, Korea, Republic of
Seoul Clinical Site 108
Seoul, Korea, Republic of
Seoul Clinical Site 109
Seoul, Korea, Republic of
Seoul Clinical Site 110
Seoul, Korea, Republic of
Ulsan Clinical Site 105
Ulsan, Korea, Republic of
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
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Study Director: Ono Pharmaceutical Co., Ltd Ono Pharmaceutical Co. Ltd
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Responsible Party: Ono Pharmaceutical Co. Ltd Identifier: NCT02175017    
Other Study ID Numbers: ONO-4538-09
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: April 2017
Keywords provided by Ono Pharmaceutical Co. Ltd:
Advanced non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents