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
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
1 other identifier
interventional
42
1 country
13
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 nonsmall-cell-lung-cancer
Started Jun 2021
Longer than P75 for phase_1 nonsmall-cell-lung-cancer
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 1, 2024
CompletedFirst Posted
Study publicly available on registry
August 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
August 7, 2024
August 1, 2024
5.3 years
August 1, 2024
August 5, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-limiting toxicities（DLT）
21 days
Adverse event(AE)
Up to 28 days after the last dose
Secondary Outcomes (12)
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
Disease control rate (DCR)
Up to 2 years
Overall survival (OS)
Up to 2 years
- +7 more secondary outcomes
Study Arms (1)
ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab
EXPERIMENTALInterventions
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Clinical stage III B/ III C with unsuitable for radical irradiation, Clinical stage IV or recurrent non-small cell lung cancer
- Life expectancy of at least 3 months
- Patients with ECOG performance status 0 or 1
You may not qualify if:
- Patients with severe complication
- Patients with multiple primary cancers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2024
First Posted
August 7, 2024
Study Start
June 1, 2021
Primary Completion (Estimated)
September 12, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
August 7, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share