NCT06542731CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 1 Aug 2024
- Start date
- 1 Jun 2021
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT06542731
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 42
- From 1 Jun 2021 to the primary completion date, 30 Oct 2025
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with multiple primary cancers
Other
- Patients with severe complication
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| Japan Anti-Tuberculosis Association Fukujuji Hospital Coordinator of this site? Confirm its status | Kiyose-shi | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Kōtoku | Japan | Unknown status |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Hyogo Medical University Hospital Coordinator of this site? Confirm its status | Nishinomiya-shi | Japan | Unknown status |
| Osaka Prefectural Hospital Organization - Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Kitasato University Hospital Coordinator of this site? Confirm its status | Sagamihara-shi | Japan | Unknown status |
| National Hospital Organization Kinki-Chuo Chest Medical Center Coordinator of this site? Confirm its status | Sakai | Japan | Unknown status |
| Saitama Cancer Center Coordinator of this site? Confirm its status | Shinden | Japan | Unknown status |
| Teikyo University Hospital Coordinator of this site? Confirm its status | tabashi City | Japan | Unknown status |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki-shi | Japan | Unknown status |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.