A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Summary
The goal of this clinical trial was to compare the efficacy and safety of anamorelin HCl (the investigational drug) to that of placebo (tablet with no drug) in patients with advanced non-small cell lung cancer and cachexia (cancer-related weight loss). The main question it aimed to answer was as follows: Do patients who receive anamorelin HCl gain more body weight and show more improvement in anorexia symptoms than those who receive placebo. Approximately 316 patients were to be enrolled in the study. Of these patients, an equal number were to be assigned to each treatment group (anamorelin HCl or placebo). Participants were to take their assigned study drug by mouth once daily for a total of 24 weeks. During this treatment period, the patients were to visit the clinical study site every 3 weeks for health and other study-related assessments. Two weeks after the last treatment, patients were to receive a follow-up phone call.
Timeline
- Start
- 2019-03-05
- Primary completion
- 2023-02-11
- Completion
- 2023-02-11
Outcome
Mixed primary results
registry analysis (superiority test); 100 mg Anamorelin HCl vs Placebo; p <0.0001; Mean Difference (Final Values) 1.345 (95% CI 0.718 to 1.971); ANOVA NCT03743051 ↗
registry analysis (superiority test); 100 mg Anamorelin HCl vs Placebo; p = 0.1514; Mean Difference (Final Values) 0.622 (95% CI -0.228 to 1.472); ANOVA NCT03743051 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anamorelin | Small molecule | 100 mg | Oral |