Trials / Active Not Recruiting
Active Not RecruitingNCT06542731
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONO-4578 | Specified dose on specified days |
| DRUG | ONO-4538 | Specified dose on specified days |
| DRUG | Docetaxel | Specified dose on specified days |
| DRUG | Ramucirumab | Specified dose on specified days |
Timeline
- Start date
- 2021-06-01
- Primary completion
- 2026-09-12
- Completion
- 2026-12-31
- First posted
- 2024-08-07
- Last updated
- 2024-08-07
Locations
13 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT06542731. Inclusion in this directory is not an endorsement.