Conditions: Cachexia Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 484
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. Pharmacokinetic (PK) samples will also be collected at Day 43 visit for population PK.

Arms:
arm 1: Anamorelin HCL 100 mg will be administered daily 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 will be orally administered daily at least one hour before meal intervention 2: Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal

Protocol document: