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

Phase 1

Active, not recruiting

• 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
• Interventions: Drug: ONO-7475; Drug: Osimertinib Mesylate

• Registration Number: NCT06525246
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-06
• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-06
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ONO-7475+Osimertinib	Osimertinib Mesylate	-
ONO-7475+Osimertinib	ONO-7475	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pharmacokinetics (Cmax)	Up to 57 Days
Pharmacokinetics (Tmax)	Up to 57 Days
Pharmacokinetics (AUC)	Up to 57 Days
Disease Control Rate (DCR)	Through study completion, an average of 2 year
Progression-Free Survival (PFS)	Through study completion, an average of 2 year
Pharmacokinetics (Ctrough)	Up to 57 Days
Objective Response Rate (ORR)	Through study completion, an average of 2 year
Overall Survival (OS)	Through study completion, an average of 3 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 lesions	Through study completion, an average of 2 year
Maximum percent change in the sum diameters of the target lesions	Through study completion, an average of 2 year

Trial Locations

Locations (13)

Kobe City Medical Center General Hospital; 🇯🇵 Kobe-shi, Hyogo, Japan

The Cancer Institute Hospital Of JFCR; 🇯🇵 Koto-Ku, Tokyo, Japan

Hyogo College Of Medicine College Hospital; 🇯🇵 Nishinomiya, Hyogo, Japan

Kanagawa Cancer Center; 🇯🇵 Yokohama shi, Kanagawa, Japan

Saitama Cancer Center; 🇯🇵 Ina, Kitaadati-gun, Saitama, Japan

Osaka International Cancer Institute; 🇯🇵 Osaka-shi, Osaka, Japan

Nigata Cancer Center Hospital; 🇯🇵 Niigata, Japan

National Hospital Organization Shikoku Cancer Center; 🇯🇵 Matsuyama-shi, Ehime, Japan

University Hospital Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto-shi, Kyoto, Japan

Osaka Medical and Pharmaceutical University Hospital; 🇯🇵 Takatsuki, Osaka, Japan

Kitasato University Hospital; 🇯🇵 Sagamihara-shi, Kanagawa, Japan

Shizuoka Cancer Center; 🇯🇵 Nagaizumi-chō, Sunto-gun, Shizuoka, Japan

Tokyo Medical University Hospital; 🇯🇵 Shinjuku-Ku, Tokyo, Japan