Non-small Cell Lung Cancer
Conditions
Brief summary
This study is PhaseⅠstudy to evaluate the tolerability and safety of ONO-4578 and ONO-4538 in combination with standard-of-care docetaxel and ramucirumab as second-line therapy in patients with advanced or recurrent NSCLC who were refractory to a combination therapy containing an anti-PD-(L)1 antibody and a platinum-based drug
Interventions
Sponsors
Ono Pharmaceutical Co. Ltd
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. Clinical stage III B/ III C with unsuitable for radical irradiation, Clinical stage IV or recurrent non-small cell lung cancer 2. Life expectancy of at least 3 months 3. Patients with ECOG performance status 0 or 1
Exclusion criteria
1. Patients with severe complication 2. Patients with multiple primary cancers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities（DLT） | 21 days |
| Adverse event(AE) | Up to 28 days after the last dose |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | Up to 2 years |
| Duration of response (DOR) | Up to 2 years |
| Time to response (TTR) | Up to 2 years |
| Best overall response (BOR) | Up to 2 years |
| Percentage of change in the sum of tumor diameters of target lesions | Up to 2 years |
| Disease control rate (DCR) | Up to 2 years |
| Changes in tumor markers（CYFRA,CEA,SLX） | Up to 2 years |
| Pharmacokinetics（Plasma concentration of ONO-4578） | Up to 28 days after the last dose |
| Pharmacokinetics（serum concentration of ONO-4538） | Up to 28 days after the last dose |
| Overall response rate (ORR) | Up to 2 years |
| Maximum percentage of change in the sum of tumor diameters of target lesions | Up to 2 years |
| Overall survival (OS) | Up to 2 years |
Countries
Japan
Outcome results
None listed