NCT03637816

Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer

Qualitative Study on Experiences Related to Anorexia and the Effects of Anamorelin and Placebo in Advanced Non-Small-Cell Lung Cancer Patients With Anorexia-Cachexia: A Preliminary Study

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II/III trial studies how well anamorelin hydrochloride works in reducing anorexia in patients with non-small cell lung cancer that has spread to other places in the body. Anamorelin hydrochloride may help to improve patients' appetite in order to stop weight loss.

Detailed description

PRIMARY OBJECTIVES: I. To qualitatively examine experiences related to anorexia in advanced lung cancer patients with anorexia-cachexia and the impact of nine weeks of treatment of oral anamorelin hydrochloride (anamorelin) (100 mg) and placebo. SECONDARY OBJECTIVES: I. To explore changes in anorexia-cachexia (measured by the Functional Assessment of Anorexia/Cachexia Treatment \[FAACT\] anorexia/cachexia subscale \[A/CS\]) in patients with advanced non-small cell cancer after 9 weeks of oral anamorelin (100 mg) or placebo. II. To explore changes in anorexia as measured by the 5-item Anorexia Symptom score (derived from the FAACT A/CS) after 9 weeks of oral anamorelin (100 mg) or placebo. III. To explore any associations between changes in anorexia with body weight, body composition (as assessed by InBody, weight scale, and L3 vertebrae compute tomography \[CT\] scan), quality of life (Functional Assessment of Cancer Illness Therapy \[FACT-G\]), Patient Global Impression of Severity (PGIS), Patient Global Impression of Change (PGIC), nutritional markers (pre-albumin, IGF-1 and IGFBP-3), inflammatory biomarkers (C-reactive protein \[CRP\], monocyte IL-6\&R, TNF-a\&R, IL-10,IL-8, IL-1\&RA), and food intake after 9 weeks of oral anamorelin (100 mg) or placebo. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive anamorelin hydrochloride orally (PO) daily for 9 weeks in the absence of disease progression or unaccepted toxicity. ARM II: Patients receive placebo PO daily for 9 weeks in the absence of disease progression or unaccepted toxicity.

Conditions

• Anorexia
• Lung Non-Small Cell Carcinoma
• Stage III Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Anamorelin Hydrochloride	Given PO
OTHER	Placebo	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-11-27
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2018-08-20
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study