Conditions: Muscle Wasting Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 330
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if the investigational drug GTx-024 can help patients with non small cell lung cancer increase physical function and maintain or gain muscle.

Detailed description:
This is a randomized, double blind, placebo controlled, multicenter, multinational efficacy and safety study in subjects with non small cell lung cancer. Subjects will be evenly randomized to placebo or GTx-024 prior to initiation of first line chemotherapy. The primary efficacy analysis will be based on total Lean Body Mass (LBM) and physical function.

Arms:
arm 1: subjects will be randomized to receive GTx-024 3mg sofgel capsule once daily for the duration of the trial arm 2: subjects will be randomized to receive matching placebo once daily for the duration of the trial

Interventions: intervention 1: GTx-024 intervention 2: placebo
Intervention descriptions: intervention 1: subjects will be randomized to receive GTx-024 3mg softgel for the duration of the trial. intervention 2: subject will receive matching placebo for the duration of the trial

Protocol document: