NCT06525246CompletedPhase 1
Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 24 Jul 2024
- Start date
- 6 Aug 2021
- Primary completion date
- 23 Jun 2025
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT06525246
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 78
- From 6 Aug 2021 to the primary completion date, 23 Jun 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, not your situation.
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
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saitama Cancer Center Coordinator of this site? Confirm its status | Ina | Japan | Unknown status |
| Kobe City Medical Center General Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Koto-ku | Japan | Unknown status |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| National Hospital Organization Shikoku Cancer Center Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Nagaizumi-chō | Japan | Unknown status |
| Nigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Hyogo College Of Medicine College Hospital Coordinator of this site? Confirm its status | Nishinomiya | Japan | Unknown status |
| 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 |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki | 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.