drugset / Trial / NCT04201769
Dexamethasone-sparing Approach Including NEPA Against Emesis Caused by Cisplatin
RandomizedParallel-groupOpen-labelSupportive care
Summary
This study evaluates the possibility to reduce the total dose of dexamethasone, when administered with NEPA, to prevent chemotherapy-induced nausea and vomiting (CINV) in Non-Small Cell Lung Cancer (NSCLC) patients receiving a cisplatin-based chemotherapy
Timeline
- Start
- 2016-11-25
- Primary completion
- 2020-04
- Completion
- 2020-04
Outcome
Met primary endpoint
paper We demonstrated the non-inferiority of a dexamethasone (DEX)-sparing (single-dose) regimen with NEPA PMID 36690734 ↗
Publications
- Celio L, Aapro M. Characteristics of nausea and its impact on health-related quality of life in cisplatin-treated patients receiving dexamethasone-sparing prophylaxis: an analysis of the LUNG-NEPA study. Support Care Cancer. 2024 Mar 4;32(3):204. doi: 10.1007/s00520-024-08406-5.
- Celio L, Bartsch R, Aapro M. Dexamethasone-sparing regimens with NEPA (netupitant/palonosetron) for the prevention of chemotherapy-induced nausea and vomiting in older patients (>65 years) fit for cisplatin: A sub-analysis from a phase 3 study. J Geriatr Oncol. 2023 Jul;14(6):101537. doi: 10.1016/j.jgo.2023.101537. Epub 2023 Jun 7.
- Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Exploratory analysis of the effect of a dexamethasone-sparing regimen for prophylaxis of cisplatin-induced emesis on food intake (LUNG-NEPA study). Sci Rep. 2023 Jan 23;13(1):1257. doi: 10.1038/s41598-023-28464-9.
- Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collova E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study. BMC Cancer. 2022 Aug 24;22(1):915. doi: 10.1186/s12885-022-10018-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 4 mg | Intravenous |
| Subject | Dexamethasone | Small molecule | 12 mg | Intravenous |
| Background | Netupitant/Palonosetron | Unknown | 0.5 mg | Oral |
| Background | Netupitant/Palonosetron | Unknown | 300 mg | Oral |