Advanced Non-small Cell Lung Cancer (NSCLC)Phase 2NCT02175017
ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing ONO-4538 in people with Advanced Non-small Cell Lung Cancer (NSCLC), run by Ono Pharmaceutical Co., Ltd. at 10 sites in South Korea.
Trial summary
The objective of the study is to investigate the efficacy and safety of ONO-4538 in subjects with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- ONO-4538
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Jun 2014to Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female ≥ 20 years of age
- Histologically or cytologically confirmed non-small cell lung cancer
- Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC
- Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1)
Who cannot join
- Current or prior severe hypersensitivity to another antibody product
- Multiple primary cancers
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Cheongju-si Clinical Site 106
Cheongju-si, North Chungcheong
Goyang-si Clinical Site 103
Goyang-si, Gyeonggi-do
Incheon Clinical Site 102
Incheon
Seongnam-si Clinical Site 104
Seongnam-si, Gyeonggi-do
Seoul Clinical Site 101
Seoul
Seoul Clinical Site 107
Seoul
Seoul Clinical Site 108
Seoul
Seoul Clinical Site 109
Seoul
Seoul Clinical Site 110
Seoul
Ulsan Clinical Site 105
Ulsan
About this study
Official title: ONO-4538 Multicenter, Open-label, Uncontrolled, Phase II Study in Advanced Non-small Cell Lung Cancer
The objective of the study is to investigate the efficacy and safety of ONO-4538 in subjects with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen.
- Being tested
- ONO-4538
- Keywords
- ONO-4538, Advanced non-small cell lung cancer (NSCLC), nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4538Drug
Also called nivolumab
ONO-4538 Study in Patients With Squamous NSCLC
ONO-4538Drug
Also called nivolumab
ONO-4538 Study in Patients With Non-Squamous NSCLC
| Study group | Role | What they receive |
|---|---|---|
| ONO-4538 for squamous non-small-cell lung cancer (NSCLC) | Experimental | In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase. Receives: Drug: ONO-4538 |
| ONO-4538 for non-squamous non-small-cell lung cancer (NSCLC) | Experimental | In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase. Receives: Drug: ONO-4538 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (Centrally Assessed)
Response rate (%) = (Number of subjects whose confirmed best overall response was complete response (CR) or partial response (PR) / Total number of FAS)*100. 95% Confidence interval (CI) was calculated by Wilson method.
Measured: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.
Secondary outcomes (4)
Response Rate (Investigator-assessed)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.
Overall Survival
Overall survival (days) = (the date of death due to any cause) - (the first dose date of investigational product) + 1. 95% CI was calculated by Kaplan-Meier method.
Measured: Follow-up phase: Every 6 months after the first day of treatment of the last subject enrolled in the study, until death or study completion.
Progression Free Survival (Centrally Assessed)
Progression free survival (days) = (the earlier date of the first documented progressive disease (PD) or death due to any cause) - (the first dose date of investigational product) + 1. 95% CI was calculated by Kaplan-Meier method.
Measured: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or until central PD was confirmed or data cut-off point.Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.
Duration of Response (Centrally Assessed)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Duration of response (days) = (the date of the first documented PD or death due to any cause after response was confirmed) - (the date of the first confirmed CR or PR) + 1. Median (95% CI) was calculated by Kaplan-Meier method.
Measured: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase(up to approximately 10 months).Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2015
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Non-small Cell Lung Cancer (NSCLC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitsunobu Tanimoto, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175017
- Sponsor's protocol ID
- ONO-4538-09
- Status last verified
- Apr 2024
- First submitted
- 18 Jun 2014
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONO-4538 Multicenter, Open-label, Uncontrolled, Phase II Study in Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02175017
- Acronym / sponsor ID
- ONO-4538-09
- Keywords
- ONO-4538, Advanced non-small cell lung cancer (NSCLC), nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to investigate the efficacy and safety of ONO-4538 in subjects with stage IIIB/IV or recurrent non-small cell lung cancer unsuited to radical radiotherapy and resistant to a platinum-based chemotherapeutic regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-4538 for squamous non-small-cell lung cancer (NSCLC) | Experimental | Drug: ONO-4538In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase. |
| ONO-4538 for non-squamous non-small-cell lung cancer (NSCLC) | Experimental | Drug: ONO-4538In each treatment cycle, patients received an intravenous infusion of nivolumab (ONO-4538) at a dose of 3 mg/kg every 2 weeks for 6 weeks. Changes in dose were not allowed. Radiological assessments (computed tomography/ magnetic resonance imaging) were conducted every 6 weeks. Patients entered subsequent treatment cycles unless they met discontinuation criteria, including disease progression, unacceptable adverse events, and consent withdrawal. Patients who were discontinued for any of these reasons entered the follow-up phase. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 20 years of age
- Histologically or cytologically confirmed non-small cell lung cancer
- Diagnosis of NSCLC in stage IIIB/IV unsuited to radical radiotherapy according to UICC-TNM classification (7th edition) or recurrent NSCLC
- Has at least one measurable lesion, as defined by the RECIST guideline (version 1.1)
Key exclusion criteria (2 listed)
- Current or prior severe hypersensitivity to another antibody product
- 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-4538Also: nivolumabONO-4538 Study in Patients With Squamous NSCLC | Drug | ONO-4538 for squamous non-small-cell lung cancer (NSCLC) |
| ONO-4538Also: nivolumabONO-4538 Study in Patients With Non-Squamous NSCLC | Drug | ONO-4538 for non-squamous non-small-cell lung cancer (NSCLC) |
Primary outcome
Response Rate (Centrally Assessed)
Time frame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.
Response rate (%) = (Number of subjects whose confirmed best overall response was complete response (CR) or partial response (PR) / Total number of FAS)*100. 95% Confidence interval (CI) was calculated by Wilson method.
4 secondary outcomes
Response Rate (Investigator-assessed)
Time frame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.
Overall Survival
Time frame: Follow-up phase: Every 6 months after the first day of treatment of the last subject enrolled in the study, until death or study completion.
Progression Free Survival (Centrally Assessed)
Time frame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or until central PD was confirmed or data cut-off point.Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.
Duration of Response (Centrally Assessed)
Time frame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase(up to approximately 10 months).Follow-up phase: Until beginning subsequent treatment for non-small cell lung cancer or PD or recurrence.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Mitsunobu Tanimoto study director
Ono Pharmaceutical Co., Ltd.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-4538 in people with Advanced Non-small Cell Lung Cancer (NSCLC), run by Ono Pharmaceutical Co., Ltd. at 10 sites in South Korea.
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 4 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 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rate (Centrally Assessed) (time frame: Screening phase: Up to 14 days before enrollment.Treatment phase: Day 43 of each cycle or end of treatment phase (up to approximately 10 months).Follow-up phase: 28 days after final dose or for discontinuation occurring 28 or fewer days after final dose.). 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 9 Dec 2024.