ONO-4538 Phase 2 study (ONO-4538-88/TASUKI-88)

ONO-4538 Phase II Study A Multicenter, Open-label, Uncontrolled Study in non-small cell lung cancer and gastric cancer (ONO-4538-88/TASUKI-88)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225262

Enrollment

Registered

2020-07-03

Start date

2021-04-15

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

Malignancies (Gastric Cancer/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.Patients with driver mutation/translocation-negative, refractory to radical radiation, and stage IIIB/IIIC/IV or recurrent non-small cell lung cancer and patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer). 2.ECOG Performance Status of 0-1 3.Patients with life expectancy of at least 90 days

Exclusion criteria

Exclusion criteria: 1. Patients with multiple cancers 2. Complication or history of severe hypersensitivity reactions to antibodies and any other drugs

Design outcomes

Primary

Measure	Time frame
efficacy Overall response rate	—

Secondary

Measure	Time frame
safety efficacy Progression-free survival, Overall survival	—

Countries

Japan

Outcome results

None listed

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