A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

257

Participants

Timeline

Start Date

August 16, 2018

Primary Completion Date

June 26, 2023

Study Completion Date

November 19, 2026

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Alectnib

Participants will receive alectinib 600 mg orally BID until completion of treatment period (24 months) or recurrence of disease , unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

DRUG

Cisplatin

"Participants will receive Cisplatin 75 milligrams per square meter (mg/m\^2) on Day 1 every 21 days IV intravenously (IV) until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."

DRUG

Vinorelbine

Participants will receive Vinorelbine 25 mg/m\^2 IV on Days 1 and 8 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.

DRUG

Gemcitabine

Participants will receive Gemcitabine 1250 mg/m\^2 on Days 1 and 8 Q21D IV until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.

DRUG

Pemetrexed

"Participants will receive 500 mg/m\^2 Day 1 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."

DRUG

Carboplatin

For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.

Trial Locations (114)

333

Chang Gung Medical Foundation - Linkou, Taoyuan District

1000

PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax, Skopje

Private Health Organization Acibadem Sistina Hospital, Skopje

1122

Orszagos Onkologiai Intezet, Budapest

1210

Krankenhaus Nord - Klinik Floridsdorf, Vienna

2050

Chris O'Brien Lifehouse, Camperdown

2065

GenesisCare North Shore, St Leonards

3000

Peter MacCallum Cancer Center, Melbourne

5000

Odense Universitetshospital, Onkologisk Afdeling R, Odense C

5004

Hetenyi Geza County Hospital, Szolnok

10002

National Taiwan University Hospital, Taipei

10043

Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano

10400

Ramathibodi Hospital, Bangkok

10408

National Cancer Center, Gyeonggi-do

10700

Siriraj Hospital, Bangkok

11555

Kasr Eieny Uni Hospital, Cairo

13015

Hopital Nord AP-HM, Marseille

13620

Seoul National University Bundang Hospital, Gyeonggi-do

15212

AHN Cancer Institute ? Allegheny General Hospital, Pittsburgh

16499

Ajou University Medical Center, Gyeonggi-do

20141

Irccs Istituto Europeo di Oncologia (IEO), Milan

21029

Vinnytsia Regional Clinical Oncology Dispensary, Vinnytsia

21565

Gachon University Gil Medical Center, Incheon

28046

Hospital Universitario La Paz, Madrid

34300

Istanbul Uni Cerrahpasa Medical Faculty Hospital, Istanbul

34376

Fachklinik für Lungenerkrankungen, Immenhausen

35100

Ege Uni Medical Faculty Hospital, Izmir

35110

Izmir Suat Seren Chest Diseases and Surgery Research Hospital, Izmir

40005

RCI Sumy Regional Clinical Oncological Dispensary, Sumy

40447

China Medical University Hospital, Taichung

40705

Taichung Veterans General Hospital, Xitun Dist.

41013

Hospital Universitario Virgen del Rocio, Seville

44280

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya

44281

Meir Medical Center, Kfar Saba

46010

Hospital Clinico Universitario de Valencia, Valencia

49102

Chemotherapy SI Dnipropetrovsk MA of MOHU, Dnipropetrovsk

49124

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH, Georgsmarienhütte

49933

CHU Angers, Angers

54007

Theageneio Hospital, Thessaloniki

55200

Medikal Park Samsun, Samsun

58128

Chonnam National University Hwasun Hospital, Jeollanam-do

60612

Rush University Medical Center, Chicago

69126

Thoraxklinik Heidelberg gGmbH, Heidelberg

71000

Clinical center University of Sarajevo, Sarajevo

75018

Hopital Bichat Claude Bernard, Paris

80131

Az. Osp. Monaldi, Napoli

94805

Institut Gustave Roussy, Villejuif

100142

Beijing Cancer Hospital, Beijing

115478

FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF, Moscow

125284

P.A. Gertsen Cancer Research Inst., Moscow

132013

Jilin Cancer Hospital, Changchun

143423

Moscow City Oncology Hospital #62, Moscovskaya Oblast

197022

Pavlov First Saint Petersburg State Medical University, Saint Petersburg

SPb City Clin Onc Dsp, Saint Petersburg

197758

Scientific Research Oncology Institute named after N.N. Petrov, Saint Petersburg

200030

Shanghai Chest Hospital, Shanghai

200032

Zhongshan Hospital Fudan University, Shanghai

230030

Healthcare Institution Grodno University Hospital, Hrodna

246012

Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary?, Homyel

250117

Shandong Cancer Hospital, Jinan

300239

Oncomed SRL, Timișoara

310022

Zhejiang Cancer Hospital, Hangzhou

350001

Fujian Medical University Union Hospital, Fujian

350086

GUZ Regional clinical hospital # 1, Krasnodar

400015

Prof Dr I Chiricuta Institute of Oncology, Cluj-Napoca

430023

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

510080

Guangdong General Hospital, Guangzhou

510852

Shenzhen People's Hospital, Shenzhen

610041

West China Hospital, Sichuan University, Chengdu

710061

First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an

3109601

Rambam Health Care Campus, Haifa

02114

MGH Cancer Center, Boston

BU-210603

Vitebsk Regional Clinical Oncology Dispensary, Vitebsk

09116

Klinikum Chemnitz gGmbH, Chemnitz

185 47

Metropolitan Hospital, Athens

00151

Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1, Rome

06156

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia, Perugia

464-8681

Aichi Cancer Center, Aichi

277-8577

National Cancer Center Hospital East, Chiba

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

734-8551

Hiroshima University Hospital, Hiroshima

003-0804

National Hospital Organization Hokkaido Cancer Center, Hokkaido

670-8520

National Hospital Organization Himeji Medical Center, Hyōgo

241-8515

Kanagawa Cancer Center, Kanagawa

860-8556

Kumamoto University Hospital, Kumamoto

606-8507

Kyoto University Hospital, Kyoto

981-0914

Sendai Kousei Hospital, Miyagi

951-8566

Niigata Cancer Center Hospital, Niigata

700-8558

Okayama University Hospital, Okayama

534-0021

Osaka City General Hospital, Osaka

411-8777

Shizuoka Cancer Center, Shizuoka

104-0045

National Cancer Center Hospital, Tokyo

113-8431

Juntendo University Hospital, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

160-0023

Tokyo Medical University Hospital, Tokyo

050054

Almaty Oncology Center, Almaty

80-214

Gdanski Uniwersytet Medyczny, Gda?sk

31-202

Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II, Krakow

10-357

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie, Olsztyn

60-569

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu, Poznan

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08308

Korea University Guro Hospital, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

08916

Hospital Universitari Germans Trias i Pujol, Barcelona

00833

Chang Gung Memorial Foundation - Kaohsiung, Kaohsiung City

01250

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital, Adana

06100

Hacettepe Uni Medical Faculty Hospital, Ankara

06500

Ankara Ataturk Chest Diseases Training and Research Hospital, Ankara

08112

Medical center of Yuriy Spizhenko LLC, Kapitanovka Village

03115

Kyiv City Clinical Oncological Center, Kyiv

SE1 9RY

Guys Hospital, London

M23 9QZ

Wythenshaw Hospital, Manchester

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY