Non-small Cell Lung CancerPhase 1NCT06542731
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
A Phase 1 study testing ONO-4578, ONO-4538 and Docetaxel in people with Non-small Cell Lung Cancer, run by Ono Pharmaceutical Co., Ltd. at 13 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- ONO-4578, ONO-4538 and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 13 sitesJapan
- Study dates
- 1 Jun 2021to 30 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with severe complication
- Patients with multiple primary cancers
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
Juntendo University Hospital
Bunkyō City
National Cancer Center Hospital
Chuo Ku, Tokyo
Japan Anti-Tuberculosis Association Fukujuji Hospital
Kiyose-shi
The Cancer Institute Hospital of JFCR
Kōtoku
Niigata Cancer Center Hospital
Niigata
Hyogo Medical University Hospital
Nishinomiya-shi
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka
Kitasato University Hospital
Sagamihara-shi
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai
Saitama Cancer Center
Shinden, Saitama
Teikyo University Hospital
tabashi City
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi
Kanagawa Cancer Center
Yokohama
About this study
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
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
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- ONO-4578, ONO-4538, Docetaxel, Ramucirumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4578Drug
Specified dose on specified days
ONO-4538Drug
Also called Nivolumab
Specified dose on specified days
DocetaxelDrug
Also called Taxotere
Specified dose on specified days
RamucirumabDrug
Also called Cyramza
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab | Experimental | Not described Receives: Drug: ONO-4578; Drug: ONO-4538; Drug: Docetaxel; Drug: Ramucirumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities（DLT）
Measured: 21 days
Adverse event(AE)
Measured: Up to 28 days after the last dose
Secondary outcomes (12)
Pharmacokinetics（Plasma concentration of ONO-4578）
Measured: Up to 28 days after the last dose
Pharmacokinetics（serum concentration of ONO-4538）
Measured: Up to 28 days after the last dose
Overall response rate (ORR)
Measured: Up to 2 years
Disease control rate (DCR)
Measured: Up to 2 years
Overall survival (OS)
Measured: Up to 2 years
Progression-free survival (PFS)
Measured: Up to 2 years
Duration of response (DOR)
Measured: Up to 2 years
Time to response (TTR)
Measured: Up to 2 years
Best overall response (BOR)
Measured: Up to 2 years
Percentage of change in the sum of tumor diameters of target lesions
Measured: Up to 2 years
Maximum percentage of change in the sum of tumor diameters of target lesions
Measured: Up to 2 years
Changes in tumor markers（CYFRA,CEA,SLX）
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jun 2021
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542731
- Sponsor's protocol ID
- ONO-4578-05
- Other IDs
- jRCT2031200346
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06542731
- Acronym / sponsor ID
- ONO-4578-05
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab | Experimental | Drug: ONO-4578, Drug: ONO-4538, Drug: Docetaxel, Drug: Ramucirumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with severe complication
- Patients with multiple primary cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-4578Specified dose on specified days | Drug | ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab |
| ONO-4538Also: NivolumabSpecified dose on specified days | Drug | ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab |
| DocetaxelAlso: TaxotereSpecified dose on specified days | Drug | ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab |
| RamucirumabAlso: CyramzaSpecified dose on specified days | Drug | ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab |
Primary outcome
Dose-limiting toxicities（DLT）
Time frame: 21 days
Adverse event(AE)
Time frame: Up to 28 days after the last dose
12 secondary outcomes
Pharmacokinetics（Plasma concentration of ONO-4578）
Time frame: Up to 28 days after the last dose
Pharmacokinetics（serum concentration of ONO-4538）
Time frame: Up to 28 days after the last dose
Overall response rate (ORR)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Time to response (TTR)
Time frame: Up to 2 years
Best overall response (BOR)
Time frame: Up to 2 years
Percentage of change in the sum of tumor diameters of target lesions
Time frame: Up to 2 years
Maximum percentage of change in the sum of tumor diameters of target lesions
Time frame: Up to 2 years
Changes in tumor markers（CYFRA,CEA,SLX）
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader study director
Ono Pharmaceutical Co., Ltd.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-4578, ONO-4538 and Docetaxel in people with Non-small Cell Lung Cancer, run by Ono Pharmaceutical Co., Ltd. at 13 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities（DLT） (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.