A Standard Regimen of Dexamethasone in Comparison to Two Dex-sparing Regimens in Addition to NEPA in Preventing CINV in naïve NSCLC Patients to be Treated With Cisplatin Based Chemotherapy: a Three-arm, Open-label, Randomized Study (LUNG-NEPA)

NCT04201769 Phase 3 UNKNOWN

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

Details

Lead sponsor	Consorzio Oncotech
Phase	Phase 3
Status	UNKNOWN
Enrolment	261
Start date	2016-11-25
Completion	2020-04

Conditions

• Chemotherapy-induced Nausea and Vomiting

Interventions

• Netupitant/Palonosetron
• Dexamethasone

Primary outcomes

• Complete Response (CR) — During the overall phase (day 1 thorough 5) of the first cycle of cisplatin-based chemotherapy (each cycle is 7 or 21 days)
  The proportion of patients achieving a complete response, defined as no emetic episode and no use of rescue medication, during the overall study period (day 1 thorough 5) of the first cycle of chemotherapy.

Countries

Italy