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Completed Phase 3 Interventional Results available

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) - 2

ClinicalTrials.gov ID: NCT03743064

Public ClinicalTrials.gov record NCT03743064. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 9:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter 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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03743064
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Helsinn Healthcare SA
Industry
Enrollment
318 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 6, 2019 (Actual)
Primary completion
Dec 27, 2022 (Actual)
Completion
Dec 27, 2022 (Actual)
Last update posted
Oct 6, 2026

2019 – 2022

United States locations

U.S. sites
19
U.S. states
14
U.S. cities
19
Facility City State ZIP Site status
The University of Arizona Cancer Center - North Campus Tucson Arizona 85719 —
Pacific Cancer Medical Center, Inc Anaheim California 92801 —
CBCC Global Research Inc Bakersfield California 93309 —
Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc. Fountain Valley California 92708 —
Marin Cancer Care Greenbrae California 94904 —
Smilow Cancer Hospital at Yale-New Haven Waterbury Connecticut 06708 —
Bond & Steele Clinic P.A. Winter Haven Florida 33881 —
Presence Infusion Care Skokie Illinois 60077 —
Siouxland Regional Cancer Center dba June E.Nylen Cancer Center Sioux City Iowa 51101 —
Cancer Center of Kansas Wichita Kansas 67214 —
Cancer and Hematology Centers of Western Michigan Grand Rapids Michigan 49503 —
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756 —
New Jersey Hematology Oncology Associates Inc Brick New Jersey 08724 —
Hunterdon Hematology Oncology LLC Flemington New Jersey 08822 —
Hematology Oncology Center at Nyack Hospital Nyack New York 10960 —
University of Rochester, Medical Center Rochester New York 14642 —
Duke Cancer Center Durham North Carolina 27710 —
Toledo Clinic Cancer Center-Toledo Toledo Ohio 43623 —
The University of Texas MD Anderson Cancer Center Houston Texas 77030-4009 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 46 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03743064, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 6, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03743064 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →