Conditions: Cachexia Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 495
Healthy volunteers: no

Brief summary:
The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

Detailed description:
This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function.

Arms:
arm 1: Investigational: Anamorelin HCl; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day. arm 2: Placebo tablets identical in appearance to active tablets; oral administration once daily

Interventions: intervention 1: Anamorelin HCl intervention 2: Placebo
Intervention descriptions: intervention 1: Anamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal intervention 2: Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.

Protocol document: