Clinical trial NCT06525246: Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
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
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-29
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT）
timeFrame: 28 days
measure: Adverse event (AE)
timeFrame: Up to 28 days after the last dose
Secondary outcomes:
measure: Pharmacokinetics (Cmax)
timeFrame: Up to 57 Days
measure: Pharmacokinetics (Tmax)
timeFrame: Up to 57 Days
measure: Pharmacokinetics (AUC)
timeFrame: Up to 57 Days
measure: Pharmacokinetics (Ctrough)
timeFrame: Up to 57 Days
measure: Objective Response Rate (ORR)
timeFrame: Through study completion, an average of 2 year
measure: Disease Control Rate (DCR)
timeFrame: Through study completion, an average of 2 year
measure: Overall Survival (OS)
timeFrame: Through study completion, an average of 3 year
measure: Progression-Free Survival (PFS)
timeFrame: Through study completion, an average of 2 year
measure: Duration of Response (DOR)
timeFrame: Through study completion, an average of 2 year
measure: Time to Response (TTR)
timeFrame: Through study completion, an average of 2 year
measure: Best Overall Response (BOR)
timeFrame: Through study completion, an average of 2 year
measure: Percent change in the sum diameters of the target lesions
timeFrame: Through study completion, an average of 2 year
measure: Maximum percent change in the sum diameters of the target lesions
timeFrame: Through study completion, an average of 2 year
Other outcomes:
Locations:
city: Matsuyama-shi
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo College Of Medicine College Hospital
state: Hyogo
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Yokohama shi
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Ina
country: Japan
facility: Saitama Cancer Center
state: Kitaadati-gun, Saitama
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
state: Kyoto
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Nagaizumi-chō
country: Japan
facility: Shizuoka Cancer Center
state: Sunto-gun, Shizuoka
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Niigata
country: Japan
facility: Nigata Cancer Center Hospital
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: