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

ONO-4538 Multicenter, Open-label, Single-arm, Phase II Study in Advanced Non-small Cell Lung Cancer

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.

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