Trials / Unknown
UnknownNCT04040361
Neoadjuvant Therapy of Pembrolizumab + Ramucirumab for PD-L1 Positive Stage IB-IIIA Lung Cancer (EAST ENERGY)
Efficacy and Safety of Neoadjuvant Therapy of Pembrolizumab Combined With Ramucirumab for PD-L1 Positive Stage IB-IIIA Lung Cancer: An Open-label Single-arm Phase II Study
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Masahiro Tsuboi · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The efficacy and safety of the neoadjuvant therapy of pembrolizumab+ ramucirumab
Detailed description
To demonstrate the antitumor activity and safety of neoadjuvant pembrolizumab plus ramucirumab followed by surgery in patients with PD-L1 positive stage IB-IIIA non-small cell lung cancer
Conditions
- Non-small Cell Lung Cancer Stage IB
- Non-small Cell Lung Cancer Stage II
- Non-small Cell Lung Cancer Stage ⅢA
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | Pembrolizumab will be administered as a dose of 200mg as a 30-minutes IV infusion, Q3W |
| DRUG | Ramucirumab | Ramucirumab will be administered as a dose of 10mg/kg as a 60-minutes IV infusion, Q3W |
| PROCEDURE | Surgery | Surgery to be performed is lobectomy or more extensive lung resection and lymph node dissection |
Timeline
- Start date
- 2019-11-30
- Primary completion
- 2022-04-30
- Completion
- 2025-11-30
- First posted
- 2019-07-31
- Last updated
- 2022-04-06
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04040361. Inclusion in this directory is not an endorsement.