Clinical trial · Interventional
ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer
ONO-4538 Multicenter, Open-label, Single-arm, Phase II Study in Advanced Non-small Cell Lung Cancer
NCT02582125CI-TRIAL-00087576completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of the study is to investigate the safety and efficacy 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONO-4538 | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ONO-4538
- description
- ONO-4538 water-soluble injection, 100 mg/vial, 3 times once every 2 weeks in each 6-week cycle
- interventionNames
- Drug: ONO-4538
Primary outcomes (1)
- measure
- Safety (Adverse events, Laboratory tests, Vital signs, ECG, Chest X-ray, ECOG)
- timeFrame
- Approximately 6 months
Secondary outcomes (3)
- measure
- Response rate (centrally assessed)
- timeFrame
- Approximately 6 months
- measure
- Response rate (study site assessment by investigator)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * Current or prior severe hypersensitivity to another antibody product * Multiple primary cancers
References
Publications (1)
- DERIVEDChen YM, Chih-Hsin Yang J, Su WC, Chong IW, Hsia TC, Lin MC, Chang GC, Chiu CH, Ho CC, Wu SY, Hung JY, Wang CC, Yang TY, Yu CJ. Nivolumab safety and efficacy in advanced, platinum-resistant, non-small cell lung cancer, radical radiotherapy-ineligible patients: A phase II study in Taiwan. J Formos Med Assoc. 2020 Dec;119(12):1817-1826. doi: 10.1016/j.jfma.2020.01.004. Epub 2020 Feb 22. PMID 32094063