A phase I study of ONO-4538(ONO-4538-67)

A Multicenter, Open-Label, Non-Comparative Study in Patients with Resectable Malignancies (Gastric Cancer/Non-Small Cell Lung Cancer)(ONO-4538-67)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223839

Enrollment

Registered

2018-03-13

Start date

2018-10-23

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. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 2. Eligible for surgical resection with curative intent 3. Pathologically confirmed diagnosis of primary NSCLC or Gastric adenocarcinoma

Exclusion criteria

Exclusion criteria: 1. Advanced or metastatic malignancies 2. Multiple cancer 3. Complication or history of severe hypersensitivity reactions to antibodies and any other drugs

Design outcomes

Primary

Measure	Time frame
safety Specific adverse events and side effects	—

Secondary

Measure	Time frame
safety efficacy exploratory Safety, Major Pathological Response (MPR), and others	—

Countries

Japan

Outcome results

None listed

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