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)

PHASE3CompletedINTERVENTIONAL
Enrollment

318

Participants

Timeline

Start Date

March 5, 2019

Primary Completion Date

February 11, 2023

Study Completion Date

February 11, 2023

Conditions
Cachexia; CancerNon Small Cell Lung Cancer
Interventions
DRUG

Anamorelin Hydrochloride

100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)

DRUG

Placebo Oral Tablet

Placebo (administered as matching placebo tablets in the fasted condition)

Trial Locations (72)

1407

Department of Medical Oncology, Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, Sofia, Sofia

5300

Department of Medical Oncology, Multiprofile Hospital for Active Treatment, Gabrovo

8000

Department of Medical Oncology, Complex Oncology Center - Burgas, Burgas, Burgas

9010

Clinic of Medical Oncology, Hospital Sveta Marina, Varna

"Clinic on Medical Oncology University Multiprofile Hospital for Active Treatment Sveta Marina, Varna", Varna

9300

Department of Medical Oncology, Multiprofile Hospital for Active Treatment - Dobrich, Dobrich, Dobrich

11000

Clinical Center of Serbia, Clinic of Pulmonology, Belgrade

Clinical Hospital Center l\emnijsJca kosa, Belgrade

Medical Military Academy, Belgrade

Oncomed-System, Specialized Hospital for Internal Diseases, Belgrade

11042

Northwell Health, Lake Success

11794

Stony Brook Cancer Center, Stony Brook

13790

Broome Oncology LLC, Johnson City

17325

Gettysburg Cancer Center, Gettysburg

20900

Local Healthcare Company of Monza (ASST Monza), Monza

29121

"Hospital Guglielmo da Saliceto", Piacenza

32204

21st Century Oncology, Jacksonville

32763

Mid Florida Hematology and Oncology Center, Orange City

33081

Oncology Reference Center, Aviano

34000

Clinical Center Kragujevac, Kragujevac

37045

Hospital Mater Salutis, Legnago

37909

Tennessee Cancer Specialist, Knoxville

39216

Jackson Oncology Associates, PLC, Jackson

43210

Ohio State University Wexner Medical Center The James Cancer Hospital and Solove Research Institute, Columbus

44124

University Hospital of Ferrara, Oncology Department, Cona

46526

Goshen Center for Cancer Care, Goshen

47014

Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), Meldola

50010

McFarland Clinic, PC, Ames

50702

MercyOne Waterloo Cancer Center, Waterloo

55049

Versilia Hospital, Lido di Camaiore

60435

Joliet Oncology Hematology Associates, Ltd, Joliet

60612

Rush University Medical Center, Chicago

72205

CARTI Cancer Center, Little Rock

80131

AOU University Luigi Vanvitelli Oncohematology Department, Napoli

84405

Community Cancer Trial of Utah, Ogden

85745

Chen, Tucson

92506

The Oncology Insitute of Hope and Innovation, Riverside

98801

Wenatchee Valley Hospital & Clinics, Wenatchee

99336

Kadlec Clinic Hematology and Oncology, Kennewick

100337

Ploiesti Municipal Hospital, Ploieşti

121467

University Headache Clinic, Moscow

153040

lvanovo Regional Oncology Center, Ivanovo

197022

First I.P. Pavlov State Medical University of St. Petersburg, Saint Petersburg

198207

City Outpatient Clinic #43, Saint Petersburg

200094

S.C. Onco Clinic Consult SA, Craiova

236016

Immanuel Kant Baltic Federal University, Kaliningrad

249036

National Medical Research Radiological Centre (Tsyb Medical Radiology Research Center), Obninsk

300166

Oncocenter - Oncologie Clinica SRL, Timișoara

305524

Kursk Regional Clinical Oncology Center, Kursk

392013

Tambov Regional Oncological Clinical Center, Tambov

400641

Medisprof S.R.L, Cluj-Napoca

410469

S.C. Pelican Impex S.R.L, Oradea

426009

Primushko Republicun Clinical Oncology Center, Izhevsk

454048

Evimed, LLC, Chelyabinsk

634028

Tomsk National Research Medical Center, Tomsk

644013

Clinical Oncology Center, Omsk

644046

Clinical Oncology Center, Omsk

06062

Hartford HealthCare Cancer Institute at the Hospital of Central Connecticut, Plainville

07207

Trinitas Comprehensive Cancer Center/Trinitas Regional Medical Center, Elizabeth

07631

Englewood Health, Englewood

23298-0230

Virginia Commonwealth University, Massey Cancer Center, Richmond

H-1121

Koranyi National Institute of Pulmonology, 6th Department of Pulmonology, Budapest

H-4032

University of Debrecen Clinical Center, Department of Pulmonology, Debrecen

1-1-8582

Veszprem County Pulmonology Institute, Farkasgyepű

H-7623

Clinical Center of the University of Pecs, Department of Pulmonology, Pécs

H-8000

Fejer County St. Gyorgy University Teaching Hospital, Pulmonology Department I, Székesfehérvár

H-5000

Jasz-Nagy Kun-Szolnok County Hetenyi Geza Hospital-Clinic, Department of Oncology, Szolnok

H - 2045

Pulmonology Institute Torokbalint, Törökbálint

00185

Umberto I Policlinico la Sapienza, Translational and Precision Medicine Department, Roma

00168

University Policlinic Fondation Agostino Gemelli, Rome

540 141

Mures County Clinical Hospital, Târgu Mureş

121 309

YitaMed, LLC, Moscow

Sponsors
All Listed Sponsors
lead

Helsinn Healthcare SA

INDUSTRY