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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

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Juntendo University Hospital
Coordinator of this site? Confirm its status
Bunkyō CityJapanUnknown status
National Cancer Center Hospital
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Chuo KuJapanUnknown status
Japan Anti-Tuberculosis Association Fukujuji Hospital
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Kiyose-shiJapanUnknown status
The Cancer Institute Hospital of JFCR
Coordinator of this site? Confirm its status
KōtokuJapanUnknown status
Niigata Cancer Center Hospital
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NiigataJapanUnknown status
Hyogo Medical University Hospital
Coordinator of this site? Confirm its status
Nishinomiya-shiJapanUnknown status
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
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OsakaJapanUnknown status
Kitasato University Hospital
Coordinator of this site? Confirm its status
Sagamihara-shiJapanUnknown status
National Hospital Organization Kinki-Chuo Chest Medical Center
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SakaiJapanUnknown status
Saitama Cancer Center
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ShindenJapanUnknown status
Teikyo University Hospital
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tabashi CityJapanUnknown status
Osaka Medical and Pharmaceutical University Hospital
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Takatsuki-shiJapanUnknown status
Kanagawa Cancer Center
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YokohamaJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.