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

• Status: Completed
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ono Pharmaceutical Co. Ltd
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

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