A phase III study of ONO-4538(ONO-4538-52/TASUKI-52)
Phase 3
Completed
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080223505
- Lead Sponsor
- ONO PHARMACEUTICAL CO.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 530
Inclusion Criteria
1. Subjects with histologically- or cytologically-confirmed non-squamous non-small cell lung cancer
2. Subjects who received a diagnosis of stage IIIB/IV or recurrent non-squamous non-small cell lung cancer
3. Subjects with at least one measurable lesion by radiographic tumor assessments per RECIST 1.1 criteria
Exclusion Criteria
1. Complication or history of severe hypersensitivity reactions to antibody products or platinum-containing compounds
2. Subjects with multiple cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Progression-free survival
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>other<br>Overall survival, Objective response rate, Safety, etc.