Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer

March 11, 2026 updated by: Ono Pharmaceutical Co. Ltd

ONO-7475-03: ONO-7475 Phase I Study An Open-label, Uncontrolled Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer

This study is to evaluate the tolerability and safety of ONO-7475 in combination with osimertinib in the first-line treatment of patients with EGFR-mutated, stage IIIB/IIIC/IV or recurrent non-small cell lung cancer (NSCLC), which is unsuitable for radical irradiation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Ehime
      • Matsuyama, Ehime, Japan
        • National Hospital Organization Shikoku Cancer Center
    • Hyōgo
      • Kobe, Hyōgo, Japan
        • Kobe City Medical Center General Hospital
      • Nishinomiya, Hyōgo, Japan
        • Hyogo College of Medicine College Hospital
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan
        • Kitasato University Hospital
      • Yokohama, Kanagawa, Japan
        • Kanagawa Cancer Center
    • Kitaadati-gun, Saitama
      • Ina, Kitaadati-gun, Saitama, Japan
        • Saitama Cancer Center
    • Kyoto
      • Kyoto, Kyoto, Japan
        • University Hospital Kyoto Prefectural University of Medicine
    • Niigata
      • Niigata, Niigata, Japan
        • Nigata Cancer Center Hospital
    • Osaka
      • Osaka, Osaka, Japan
        • Osaka International Cancer Institute
      • Takatsuki, Osaka, Japan
        • Osaka Medical and Pharmaceutical University Hospital
    • Sunto-gun, Shizuoka
      • Nagaizumi-chō, Sunto-gun, Shizuoka, Japan
        • Shizuoka Cancer Center
    • Tokyo
      • Koto-Ku, Tokyo, Japan
        • The Cancer Institute Hospital of JFCR
      • Shinjuku-Ku, Tokyo, Japan
        • Tokyo Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with stage IIIB/IIIC/IV or recurrent NSCLC, which is unsuitable for radical irradiation
  2. Patients with confirmed EGFR gene exon 19 deletion or EGFR gene exon 21 mutation(L858R)and who are scheduled to receive osimertinib
  3. Patient has an ECOG performance status of 0-1

Exclusion Criteria:

  1. Patients with severe complication
  2. Patients with multiple primary cancers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONO-7475+Osimertinib
Drug: ONO-7475
Specified dose, once daily
Drug: Osimertinib Mesylate
Specified dose, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT）
Time Frame: 28 days
28 days
Adverse event (AE)
Time Frame: Up to 28 days after the last dose
Up to 28 days after the last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (Cmax)
Time Frame: Up to 57 Days
Up to 57 Days
Pharmacokinetics (Tmax)
Time Frame: Up to 57 Days
Up to 57 Days
Pharmacokinetics (AUC)
Time Frame: Up to 57 Days
Up to 57 Days
Pharmacokinetics (Ctrough)
Time Frame: Up to 57 Days
Up to 57 Days
Objective Response Rate (ORR)
Time Frame: Through study completion, an average of 2 year
Through study completion, an average of 2 year
Disease Control Rate (DCR)
Time Frame: Through study completion, an average of 2 year
Through study completion, an average of 2 year
Overall Survival (OS)
Time Frame: Through study completion, an average of 3 year
Through study completion, an average of 3 year
Progression-Free Survival (PFS)
Time Frame: Through study completion, an average of 2 year
Through study completion, an average of 2 year
Duration of Response (DOR)
Time Frame: Through study completion, an average of 2 year
Through study completion, an average of 2 year
Time to Response (TTR)
Time Frame: Through study completion, an average of 2 year
Through study completion, an average of 2 year
Best Overall Response (BOR)
Time Frame: Through study completion, an average of 2 year
Through study completion, an average of 2 year
Percent change in the sum diameters of the target lesions
Time Frame: Through study completion, an average of 2 year
Through study completion, an average of 2 year
Maximum percent change in the sum diameters of the target lesions
Time Frame: Through study completion, an average of 2 year
Through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2021

Primary Completion (Actual)

June 23, 2025

Study Completion (Actual)

June 23, 2025

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-7475-03
  • jRCT2051210045 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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