A phase III study of ONO-4538(ONO-4538-52/TASUKI-52)

A Multicenter, Randomized, Double-Blind Trial in Subjects with Non-Squamous Non-Small Cell Lung Cancer(ONO-4538-52/TASUKI-52)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223505

Enrollment

530

Registered

2017-04-12

Start date

2017-06-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : ONO-4538 INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Complication or history of severe hypersensitivity reactions to antibody products or platinum-containing compounds 2. Subjects with multiple cancer

Design outcomes

Primary

Measure	Time frame
efficacy Progression-free survival	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics other Overall survival, Objective response rate, Safety, etc.	—

Countries

Asia except Japan, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026