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An Open-label, Uncontrolled Study 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 Non-small Cell Lung Cancer
Sponsor: Ono Pharmaceutical Co. Ltd
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
Official title: Phase 1 Study of ONO-4578 Given as Combinations of ONO-4578, ONO-4538, Docetaxel and Ramucirumab in Subjects With Metastatic Non-small Cell Lung Cancer Who Have Had Disease Progression During or After One Prior First-line Anti-PD-(L) 1 Antibody and Platinum-based Chemotherapy for Advanced/Metastatic Disease
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2021-06-01
Completion Date
2026-12-31
Last Updated
2024-08-07
Healthy Volunteers
No
Conditions
Interventions
ONO-4578
Specified dose on specified days
ONO-4538
Specified dose on specified days
Docetaxel
Specified dose on specified days
Ramucirumab
Specified dose on specified days
Locations (13)
Saitama Cancer Center
Shinden, Saitama, Japan
National Cancer Center Hospital
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