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Completed

NCT Number: NCT06525246

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.

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Key information

Conditions

Stage IIIB Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung EGFR Mutation-Related Tumors Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Recurrent Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Stage IIIC Non-Small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with severe complication
  • Patients with multiple primary cancers

Treatment and study plan

ONO-7475

Drug

Specified dose, once daily

Osimertinib Mesylate

Drug

Specified dose, once daily

Primary outcomes

  1. Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT）

    Time frame: 28 days

  2. Adverse event (AE)

    Time frame: Up to 28 days after the last dose

Secondary outcomes

  1. Pharmacokinetics (Cmax)

    Time frame: Up to 57 Days

  2. Pharmacokinetics (Tmax)

    Time frame: Up to 57 Days

  3. Pharmacokinetics (AUC)

    Time frame: Up to 57 Days

  4. Pharmacokinetics (Ctrough)

    Time frame: Up to 57 Days

  5. Objective Response Rate (ORR)

    Time frame: Through study completion, an average of 2 year

  6. Disease Control Rate (DCR)

    Time frame: Through study completion, an average of 2 year

  7. Overall Survival (OS)

    Time frame: Through study completion, an average of 3 year

  8. Progression-Free Survival (PFS)

    Time frame: Through study completion, an average of 2 year

  9. Duration of Response (DOR)

    Time frame: Through study completion, an average of 2 year

  10. Time to Response (TTR)

    Time frame: Through study completion, an average of 2 year

  11. Best Overall Response (BOR)

    Time frame: Through study completion, an average of 2 year

  12. Percent change in the sum diameters of the target lesions

    Time frame: Through study completion, an average of 2 year

  13. Maximum percent change in the sum diameters of the target lesions

    Time frame: Through study completion, an average of 2 year

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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