Clinical trial · Interventional
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
Phase 1 Study of ONO-4578 Given as Combinations of ONO-4578, ONO-4538, Docetaxel and Ramucirumab in Subjects With Metastatic Non-small Cell Lung Cancer Who Have Had Disease Progression During or After One Prior First-line Anti-PD-(L) 1 Antibody and Platinum-based Chemotherapy for Advanced/Metastatic Disease
- 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)
This study is PhaseⅠstudy to evaluate the tolerability and safety 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 NSCLC who were refractory to a combination therapy containing an anti-PD-(L)1 antibody and a platinum-based drug
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| ONO-4538 | Drug | Nivolumab | ALIAS |
| ONO-4578 | Drug | — | UNRESOLVED |
| Ramucirumab | Drug | Ramucirumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ONO-4578＋ONO-4538＋docetaxel ＋ ramucirumab
- interventionNames
- Drug: ONO-4578
- Drug: ONO-4538
- Drug: Docetaxel
- Drug: Ramucirumab
Primary outcomes (2)
- measure
- Dose-limiting toxicities（DLT）
- timeFrame
- 21 days
- measure
- Adverse event(AE)
- timeFrame
- Up to 28 days after the last dose
Secondary outcomes (12)
- measure
- Pharmacokinetics（Plasma concentration of ONO-4578）
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical stage III B/ III C with unsuitable for radical irradiation, Clinical stage IV or recurrent non-small cell lung cancer 2. Life expectancy of at least 3 months 3. Patients with ECOG performance status 0 or 1 Exclusion Criteria: 1. Patients with severe complication 2. Patients with multiple primary cancers
References
Publications (0)
Data not yet available