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 (NSCLC)

Treatments: Drug: ONO-4538

Study type: Interventional

Funder types: Industry

Identifiers

NCT02175017

ONO-4538-09

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

ONO-4538 for squamous non-small-cell lung cancer (NSCLC)

Experimental group

Description:

In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase.

Treatment:

Drug: ONO-4538

Drug: ONO-4538

ONO-4538 for non-squamous non-small-cell lung cancer (NSCLC)

Experimental group

Description:

In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase.

Treatment:

Drug: ONO-4538

Drug: ONO-4538