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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4578 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities（DLT） | 21 days | |
| Adverse event(AE) | Up to 28 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saitama Cancer Center | Shinden | Saitama | Japan | |||
| National Cancer Center Hospital |
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| ONO-4538 |
| Drug |
Specified dose on specified days |
|
|
| Docetaxel | Drug | Specified dose on specified days |
|
|
| Ramucirumab | Drug | Specified dose on specified days |
|
|
| Overall response rate (ORR) |
| Up to 2 years |
| Disease control rate (DCR) | Up to 2 years |
| Overall survival (OS) | Up to 2 years |
| 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 |
| Maximum percentage of change in the sum of tumor diameters of target lesions | Up to 2 years |
| Changes in tumor markers（CYFRA,CEA,SLX） | Up to 2 years |
| Chuo Ku |
| Tokyo |
| Japan |
| Juntendo University Hospital | Bunkyō City | Japan |
| Teikyo University Hospital | Itabashi-ku | Japan |
| Japan Anti-Tuberculosis Association Fukujuji Hospital | Kiyose-shi | Japan |
| The Cancer Institute Hospital of JFCR | Kōtoku | Japan |
| Niigata Cancer Center Hospital | Niigata | Japan |
| Hyogo Medical University Hospital | Nishinomiya-shi | Japan |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute | Osaka | Japan |
| Kitasato University Hospital | Sagamihara-shi | Japan |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Sakai | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Takatsuki-shi | Japan |
| Kanagawa Cancer Center | Yokohama | Japan |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000077143 | Docetaxel |
| D000096662 | Ramucirumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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