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

• Sponsor: Ono Pharmaceutical Co. Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02175017
• Collaborator: (none)
• Enrollment: 104
• Locations: 10
• Arm: 1
• Actual Duration (Months): 80.1
• Patients Per Site: 10.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 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
• Actual Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Feb 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Response rate (centrally assessed) [Approximately 6 months]

Secondary Outcome Measures

1. Response rate (study site assessment by investigator) [Approximately 6 months]

2. Overall survival [Approximately 1 year]

3. Progression free survival [Approximately 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cheongju-si Clinical Site 106	Cheongju-si	Chungcheongbuk-do	Korea, Republic of
2	Goyang-si Clinical Site 103	Goyang-si	Gyeonggi-do	Korea, Republic of
3	Seongnam-si Clinical Site 104	Seongnam-si	Gyeonggi-do	Korea, Republic of
4	Incheon Clinical Site 102	Incheon		Korea, Republic of
5	Seoul Clinical Site 101	Seoul		Korea, Republic of
6	Seoul Clinical Site 107	Seoul		Korea, Republic of
7	Seoul Clinical Site 108	Seoul		Korea, Republic of
8	Seoul Clinical Site 109	Seoul		Korea, Republic of
9	Seoul Clinical Site 110	Seoul		Korea, Republic of
10	Ulsan Clinical Site 105	Ulsan		Korea, Republic of

Sponsors and Collaborators

• Ono Pharmaceutical Co. Ltd

Investigators

• Study Director: Mitsunobu Tanimoto, Ono Pharmaceutical Co. Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ono Pharmaceutical Co. Ltd
• ClinicalTrials.gov Identifier: NCT02175017
• Other Study ID Numbers: ONO-4538-09
• First Posted: Jun 26, 2014
• Last Update Posted: Mar 23, 2021
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Ono Pharmaceutical Co. Ltd: ONO-4538; Advanced non-small cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Nivolumab

Study Results

No Results Posted as of Mar 23, 2021