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

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Advanced Non-small Cell Lung Cancer

Treatments: Drug: ONO-4538

Study type: Interventional

Funder types: Industry

Identifiers

NCT02582125

ONO-4538-25

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

ONO-4538

Experimental group

Description:

ONO-4538 water-soluble injection, 100 mg/vial, 3 times once every 2 weeks in each 6-week cycle

Treatment:

Drug: ONO-4538