ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer
- Registration Number
- NCT02582125
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ONO-4538 ONO-4538 ONO-4538 water-soluble injection, 100 mg/vial, 3 times once every 2 weeks in each 6-week cycle
- Primary Outcome Measures
Name Time Method Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG) Approximately 6 months
- Secondary Outcome Measures
Name Time Method Response rate (centrally assessed) Approximately 6 months Response rate (study site assessment by investigator) Approximately 6 months Overall survival Approximately 1 year
Trial Locations
- Locations (8)
Tainan Clinical Site 1
🇨🇳Tainan, Taiwan
Taichung Clinical Site 2
🇨🇳Taichung, Taiwan
Tainan Clinical Site 2
🇨🇳Tainan, Taiwan
Taipei Clinical Site 3
🇨🇳Taipei, Taiwan
Taichung Clinical Site 1
🇨🇳Taichung, Taiwan
Tainan Clinical Site 3
🇨🇳Tainan, Taiwan
Taipei Clinical Site 1
🇨🇳Taipei, Taiwan
Taipei Clinical Site 2
🇨🇳Taipei, Taiwan