Conditions: Carcinoma, Non-Small-Cell Lung
Allocation:  | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
This is a non-randomized, open label, two-cohort, multi-institutional study to evaluate the use of diarrheal management tools intended to facilitate timely intervention and treatment modifications due to afatinib treatment-related diarrhea in patients with EGFR mutations-positive adenocarcinoma of the lung. Patients in Cohort 1 will follow diarrhea management. Patients in Cohort 2 will receive prophylactic loperamide starting the fist day of afatinib treatment.

Detailed description:

Arms:
arm 1: afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1. arm 2: afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.

Interventions: intervention 1: afatinib intervention 2: loperamide
Intervention descriptions: intervention 1: Daily treatment starting 40 mg per day intervention 2: Follow cohort assignment and diarrhea management guidelines

Protocol document: