Floatz Rating
BB68/100
Confidence
Indicative
Sponsor
Ono Pharmaceutical Co., Ltd.
Modality
UNKNOWN
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
62High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06542731CT.gov 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 | — | Active Not Recruiting | — | — | — |
NCT03117049CT.gov Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52) | — | Completed | — | — | — |
NCT02582125CT.gov ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer | — | Completed | — | — | — |
NCT02175017CT.gov ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
81High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Non-Small Cell Lung Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Ono-4538 (this asset) | Ono Pharmaceutical Co., Ltd. | P3 | BB · 68 |
| Necitumumab | Jonsson Comprehensive Cancer Center | P3 | BBB |
| Glumetinib | Shanghai JMT-Bio Inc. | P3 | BBB |
| Veliparib | AbbVie | P3 | BBB |
| d-0316 | Betta Pharmaceuticals Co., Ltd. | P2/3 | BBB |
| Icotinib | The First Affiliated Hospital of Guangzhou Medical University | P4 | BBB |
| Zoledronate | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | P4 | BBB |
| Onartuzumab | Hoffmann-La Roche | P3 | BBB |
| Avitinib | Hangzhou ACEA Pharmaceutical Research Co., Ltd. | P3 | BBB |
+42 more in the Non-Small Cell Lung Carcinoma cohort
Other indications for Ono-4538
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Malignant Pancreatic Neoplasm | — | P1 | CC · 42 |
| Cancer | — | P1 | CC · 42 |
| Neoplasm | — | P1 | C · 36 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Ono-4538 in Non-Small Cell Lung Carcinoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/ono-4538-non-small-cell-lung-carcinoma
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