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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06525246
Enrollment
78
Registered
2024-07-29
Start date
2021-08-06
Completion date
2025-06-23
Last updated
2026-03-13

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

Conditions

Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Recurrent Non-Small Cell Lung Cancer, EGFR Mutation-Related Tumors

Brief summary

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.

Interventions

DRUGONO-7475

Specified dose, once daily

DRUGOsimertinib Mesylate

Specified dose, once daily

Sponsors

Ono Pharmaceutical Co. Ltd
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT）28 days
Adverse event (AE)Up to 28 days after the last dose

Secondary

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

Countries

Japan

Contacts

STUDY_DIRECTORProject Leader

Ono Pharmaceutical Co. Ltd

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026