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

• Sponsor: Ono Pharmaceutical Co. Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02582125
• Collaborator: (none)
• Enrollment: 53
• Locations: 8
• Arm: 1
• Actual Duration (Months): 71.1
• Patients Per Site: 6.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ONO-4538 Multicenter, Open-label, Single-arm, Phase II Study in Advanced Non-small Cell Lung Cancer
• Actual Study Start Date: Jan 27, 2016
• Actual Primary Completion Date: Jan 4, 2021
• Actual Study Completion Date: Dec 31, 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. Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG) [Approximately 6 months]

Secondary Outcome Measures

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

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

3. Overall survival [Approximately 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taichung Clinical Site 1	Taichung		Taiwan
2	Taichung Clinical Site 2	Taichung		Taiwan
3	Tainan Clinical Site 1	Tainan		Taiwan
4	Tainan Clinical Site 2	Tainan		Taiwan
5	Tainan Clinical Site 3	Tainan		Taiwan
6	Taipei Clinical Site 1	Taipei		Taiwan
7	Taipei Clinical Site 2	Taipei		Taiwan
8	Taipei Clinical Site 3	Taipei		Taiwan

Sponsors and Collaborators

• Ono Pharmaceutical Co. Ltd

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ono Pharmaceutical Co. Ltd
• ClinicalTrials.gov Identifier: NCT02582125
• Other Study ID Numbers: ONO-4538-25
• First Posted: Oct 21, 2015
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• 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 Apr 27, 2022