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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Specified dose, once daily
Specified dose, once daily
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Hyogo College Of Medicine College Hospital
Nishinomiya, Hyōgo, Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Saitama Cancer Center
Ina, Kitaadati-gun, Saitama, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Nigata Cancer Center Hospital
Niigata, Niigata, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
...and 3 more locations
Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT）
Time frame: 28 days
Adverse event (AE)
Time frame: Up to 28 days after the last dose
Pharmacokinetics (Cmax)
Time frame: Up to 57 Days
Pharmacokinetics (Tmax)
Time frame: Up to 57 Days
Pharmacokinetics (AUC)
Time frame: Up to 57 Days
Pharmacokinetics (Ctrough)
Time frame: Up to 57 Days
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 2 year
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 2 year
Overall Survival (OS)
Time frame: Through study completion, an average of 3 year
Progression-Free Survival (PFS)
Time frame: Through study completion, an average of 2 year
Duration of Response (DOR)
Time frame: Through study completion, an average of 2 year
Time to Response (TTR)
Time frame: Through study completion, an average of 2 year
Best Overall Response (BOR)
Time frame: 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
Maximum percent change in the sum diameters of the target lesions
Time frame: Through study completion, an average of 2 year
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