Stage IIIB Non-small Cell Lung CancerPhase 1NCT06525246
Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
A Phase 1 study testing ONO-7475 and Osimertinib Mesylate in people with Stage IIIB Non-small Cell Lung Cancer and Stage IIIC Non-Small Cell Lung Cancer, run by Ono Pharmaceutical Co., Ltd. at 13 sites in Japan.
Trial summary
This study is to evaluate the tolerability and safety of ONO-7475 in combination with osimertinib in the first-line treatment of patients with EGFR-mutated, stage IIIB/IIIC/IV or recurrent non-small cell lung cancer (NSCLC), which is unsuitable for radical irradiation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- What is being tested?
- ONO-7475 and Osimertinib Mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 13 sitesJapan
- Study dates
- 6 Aug 2021to 23 Jun 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
- Patients with stage IIIB/IIIC/IV or recurrent NSCLC, which is unsuitable for radical irradiation
- Patients with confirmed EGFR gene exon 19 deletion or EGFR gene exon 21 mutation(L858R)and who are scheduled to receive osimertinib
- Patient has an ECOG performance status of 0-1
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
Saitama Cancer Center
Ina, Kitaadati-gun, Saitama
Kobe City Medical Center General Hospital
Kobe, Hyōgo
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime
Shizuoka Cancer Center
Nagaizumi-chō, Sunto-gun, Shizuoka
Nigata Cancer Center Hospital
Niigata, Niigata
Hyogo College Of Medicine College Hospital
Nishinomiya, Hyōgo
Osaka International Cancer Institute
Osaka, Osaka
Kitasato University Hospital
Sagamihara-shi, Kanagawa
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka
Kanagawa Cancer Center
Yokohama, Kanagawa
About this study
Official title: ONO-7475-03: ONO-7475 Phase I Study An Open-label, Uncontrolled Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
This study is to evaluate the tolerability and safety of ONO-7475 in combination with osimertinib in the first-line treatment of patients with EGFR-mutated, stage IIIB/IIIC/IV or recurrent non-small cell lung cancer (NSCLC), which is unsuitable for radical irradiation.
- Conditions
- Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Recurrent Non-Small Cell Lung Cancer, EGFR Mutation-Related Tumors
- Being tested
- ONO-7475, Osimertinib Mesylate
- 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-7475Drug
Specified dose, once daily
Osimertinib MesylateDrug
Specified dose, once daily
| Study group | Role | What they receive |
|---|---|---|
| ONO-7475+Osimertinib | Experimental | Not described Receives: Drug: ONO-7475; Drug: Osimertinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT）
Measured: 28 days
Adverse event (AE)
Measured: Up to 28 days after the last dose
Secondary outcomes (13)
Pharmacokinetics (Cmax)
Measured: Up to 57 Days
Pharmacokinetics (Tmax)
Measured: Up to 57 Days
Pharmacokinetics (AUC)
Measured: Up to 57 Days
Pharmacokinetics (Ctrough)
Measured: Up to 57 Days
Objective Response Rate (ORR)
Measured: Through study completion, an average of 2 year
Disease Control Rate (DCR)
Measured: Through study completion, an average of 2 year
Overall Survival (OS)
Measured: Through study completion, an average of 3 year
Progression-Free Survival (PFS)
Measured: Through study completion, an average of 2 year
Duration of Response (DOR)
Measured: Through study completion, an average of 2 year
Time to Response (TTR)
Measured: Through study completion, an average of 2 year
Best Overall Response (BOR)
Measured: Through study completion, an average of 2 year
Percent change in the sum diameters of the target lesions
Measured: Through study completion, an average of 2 year
Maximum percent change in the sum diameters of the target lesions
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start6 Aug 2021
- Primary completion23 Jun 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIB 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
- 78 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
- NCT06525246
- Sponsor's protocol ID
- ONO-7475-03
- Other IDs
- jRCT2051210045
- Status last verified
- Mar 2026
- First submitted
- 24 Jul 2024
- Last updated
- 13 Mar 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONO-7475-03: ONO-7475 Phase I Study An Open-label, Uncontrolled Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06525246
- Acronym / sponsor ID
- ONO-7475-03
- Conditions
- Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Recurrent Non-Small Cell Lung Cancer, EGFR Mutation-Related Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 29 Jul 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 to evaluate the tolerability and safety of ONO-7475 in combination with osimertinib in the first-line treatment of patients with EGFR-mutated, stage IIIB/IIIC/IV or recurrent non-small cell lung cancer (NSCLC), which is unsuitable for radical irradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONO-7475+Osimertinib | Experimental | Drug: ONO-7475, Drug: Osimertinib Mesylate |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with stage IIIB/IIIC/IV or recurrent NSCLC, which is unsuitable for radical irradiation
- Patients with confirmed EGFR gene exon 19 deletion or EGFR gene exon 21 mutation(L858R)and who are scheduled to receive osimertinib
- Patient has an ECOG performance status of 0-1
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-7475Specified dose, once daily | Drug | ONO-7475+Osimertinib |
| Osimertinib MesylateSpecified dose, once daily | Drug | ONO-7475+Osimertinib |
Primary outcome
Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT）
Time frame: 28 days
Adverse event (AE)
Time frame: Up to 28 days after the last dose
13 secondary outcomes
Pharmacokinetics (Cmax)
Time frame: Up to 57 Days
Pharmacokinetics (Tmax)
Time frame: Up to 57 Days
Pharmacokinetics (AUC)
Time frame: Up to 57 Days
Pharmacokinetics (Ctrough)
Time frame: Up to 57 Days
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 2 year
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 2 year
Overall Survival (OS)
Time frame: Through study completion, an average of 3 year
Progression-Free Survival (PFS)
Time frame: Through study completion, an average of 2 year
Duration of Response (DOR)
Time frame: Through study completion, an average of 2 year
Time to Response (TTR)
Time frame: Through study completion, an average of 2 year
Best Overall Response (BOR)
Time frame: Through study completion, an average of 2 year
Percent change in the sum diameters of the target lesions
Time frame: Through study completion, an average of 2 year
Maximum percent change in the sum diameters of the target lesions
Time frame: Through study completion, an average of 2 year
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 13 Mar 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-7475 and Osimertinib Mesylate in people with Stage IIIB Non-small Cell Lung Cancer and Stage IIIC 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 13 Mar 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） Dose-limiting toxicities（DLT） Dose-limiting toxicities（DLT） (time frame: 28 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 13 Mar 2026.