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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03456076

Studienbeginn:
August 2018

Letztes Update:
01.04.2021

Wirkstoff:
Alectnib, Vinorelbine, Pemetrexed, Carboplatin, Cisplatin, Gemcitabine

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: BO40336 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. and Canada)
E-Mail: global-roche-genentech-trials@gene.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 210)

Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo
13353 Berlin
(Berlin)
GermanyZurückgezogen» Google-Maps
Klinikum Chemnitz gGmbH
09116 Chemnitz
(Sachsen)
GermanyRekrutierend» Google-Maps
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
49124 Georgsmarienhütte
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Thoraxklinik Heidelberg gGmbH
69126 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Fachklinik für Lungenerkrankungen
34376 Immenhausen
(Hessen)
GermanyRekrutierend» Google-Maps
Lungenklinik Lostau
39291 Lostau
(Sachsen-Anhalt)
GermanyZurückgezogen» Google-Maps
Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie/Onkologie
33098 Paderborn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Rush University Medical Center
60612 Chicago
United StatesRekrutierend» Google-Maps
University of Michigan
48109-0934 Ann Arbor
United StatesZurückgezogen» Google-Maps
Allegheny General Hospital
15212 Pittsburgh
United StatesRekrutierend» Google-Maps
Northern Cancer Institute
2065 St Leonards
AustraliaRekrutierend» Google-Maps
Sunshine Coast University Hospital; The Adem Crosby Centre
4575 Birtinya
AustraliaZurückgezogen» Google-Maps
Cairns Base Hospital; Cancer Care Centre
4870 Cairns
AustraliaRekrutierend» Google-Maps
Princess Alexandra Hospital
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps
Peter MacCallum Cancer Center
3002 East Melbourne
AustraliaRekrutierend» Google-Maps
Klinikum Wels-Grieskirchen; Lungenabt.
4600 Wels
AustriaZurückgezogen» Google-Maps
Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
1210 Wien
AustriaAktiv, nicht rekrutierend» Google-Maps
Healthcare Institution Grodno Regional Clinical Hospital; Regional Oncologic Dispensary
230030 Grodno
BelarusRekrutierend» Google-Maps
State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology
223040 A/g Lesnoy, Minsk Region
BelarusRekrutierend» Google-Maps
Healthcare Institution "Gomel Regional Clinical Oncologic Dispensary"
246012 Gomel
BelarusRekrutierend» Google-Maps
Minsk City Clinical Oncologic Dispensary
BU-220013 Minsk
BelarusRekrutierend» Google-Maps
Mogilev Regional Oncology Center
212018 Mogilev
BelarusRekrutierend» Google-Maps
Vitebsk Regional Clinical Oncology Dispensary
BU-210603 Vitebsk
BelarusRekrutierend» Google-Maps
University Clinical Centre of the Republic of Srpska; Clinic for Pulmonary Diseases
78000 Banja Luka
Bosnia and HerzegovinaRekrutierend» Google-Maps
Uni Hospital Mostar
88000 Mostar
Bosnia and HerzegovinaRekrutierend» Google-Maps
Clinic of Oncology, University Clinical Center Sarajevo
7100 Sarajevo
Bosnia and HerzegovinaRekrutierend» Google-Maps
University Clinical Center Tuzla; Clinic for Pulmonary Diseases
75000 Tuzla
Bosnia and HerzegovinaRekrutierend» Google-Maps
Hu Nan Provincial Cancer Hospital
410006 Changsha
ChinaNoch nicht rekrutierend» Google-Maps
West China Hospital, Sichuan University
610041 Chengdu
ChinaNoch nicht rekrutierend» Google-Maps
Fujian Medical University Union Hospital
350001 Fujian
ChinaRekrutierend» Google-Maps
Shandong Cancer Hospital
250117 Jinan
ChinaNoch nicht rekrutierend» Google-Maps
Yunnan Cancer Hospital
650118 Kunming
ChinaNoch nicht rekrutierend» Google-Maps
Zhongshan Hospital Fudan University
200032 Shanghai
ChinaAktiv, nicht rekrutierend» Google-Maps
Liaoning Provincial Cancer Hospital
110042 Shengyang
ChinaZurückgezogen» Google-Maps
First Affiliated Hospital of Soochow University
215006 Suzhou
ChinaZurückgezogen» Google-Maps
Union Hospital Tongji Medical College Huazhong University of Science and Technology
430023 Wuhan City
ChinaRekrutierend» Google-Maps
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
710038 Xi'an
ChinaZurückgezogen» Google-Maps
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
710061 Xi'an
ChinaRekrutierend» Google-Maps
Zhejiang Cancer Hospital
310022 Zhejiang
ChinaAktiv, nicht rekrutierend» Google-Maps
Odense Universitetshospital, Onkologisk Afdeling R
5000 Odense C
DenmarkRekrutierend» Google-Maps
Kasr Eieny Uni Hospital; Oncology (Nemrock)
11555 Cairo
EgyptRekrutierend» Google-Maps
Mansoura University; Oncology center
35111 Mansoura
EgyptRekrutierend» Google-Maps
Hôpital Arnaud de Villeneuve
34295 Montpellier
FranceRekrutierend» Google-Maps
Hopital Bichat Claude Bernard; Oncologie Serv.
75018 Paris
FranceRekrutierend» Google-Maps
Ch De Saint Quentin; Medecine B14
02321 St Quentin
FranceRekrutierend» Google-Maps
Hopitaux Universitaires de Strasbourg
67091 Strasbourg
FranceZurückgezogen» Google-Maps
Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie
83000 Toulon
FranceRekrutierend» Google-Maps
Institut Gustave Roussy; Pathologie Thoracique
94805 Villejuif cedex
FranceAktiv, nicht rekrutierend» Google-Maps
General Hospital "G.Papanikolaou"; Pulmonogy Clinic
570 10 Asvestochori
GreeceRekrutierend» Google-Maps
Uoa Sotiria Hospital; Oncology
115 27 Athens
GreeceRekrutierend» Google-Maps
Theageneio Hospital
54007 Thessaloniki
GreeceNoch nicht rekrutierend» Google-Maps
Euromedical General Clinic of Thessaloniki; Oncology Department
546 45 Thessaloniki
GreeceZurückgezogen» Google-Maps
Semmelweis Egyetem, AOK, Pulmonologiai Klinika
1083 Budapest
HungaryRekrutierend» Google-Maps
University of Pecs; 1St Department of Medicine
7623 Pecs
HungaryRekrutierend» Google-Maps
Hetenyi Geza County Hospital; Onkologiai Kozpont
5004 Szolnok
HungaryRekrutierend» Google-Maps
Rambam Health Care Campus; Oncology
3109601 Haifa
IsraelRekrutierend» Google-Maps
Rabin MC- Belinson campus
4941492 Petach Tikva
IsraelRekrutierend» Google-Maps
Az. Osp. Monaldi; 1 Pneumologia Oncologica
80131 Napoli
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
40138 Bologna
ItalyZurückgezogen» Google-Maps
Azienda Osp. Univ di Modena; Dept Onc & Hem
41100 Modena
ItalyRekrutierend» Google-Maps
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
48100 Ravenna
ItalyRekrutierend» Google-Maps
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
33081 Aviano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1
00151 Roma
ItalyRekrutierend» Google-Maps
A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia
26100 Cremona
ItalyRekrutierend» Google-Maps
Irccs Ospedale San Raffaele;Oncologia Medica
20132 Milano
ItalyRekrutierend» Google-Maps
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
20141 Milano
ItalyRekrutierend» Google-Maps
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
10043 Orbassano
ItalyRekrutierend» Google-Maps
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
56124 Pisa
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
06156 Perugia
ItalyRekrutierend» Google-Maps
Fujita Health University Hospital
470-1192 Aichi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Chiba
JapanRekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka
JapanRekrutierend» Google-Maps
Hiroshima University Hospital
734-8551 Hiroshima
JapanRekrutierend» Google-Maps
National Hospital Organization Hokkaido Cancer Center
003-0804 Hokkaido
JapanRekrutierend» Google-Maps
Hyogo College of Medicine Hospital
663-8501 Hyogo
JapanRekrutierend» Google-Maps
National Hospital Organization Himeji Medical Center
670-8520 Hyogo
JapanRekrutierend» Google-Maps
Kumamoto University Hospital
860-8556 Kumamoto
JapanAktiv, nicht rekrutierend» Google-Maps
Kyoto University Hospital
606-8507 Kyoto
JapanAktiv, nicht rekrutierend» Google-Maps
Sendai Kousei Hospital
980-0873 Miyagi
JapanAktiv, nicht rekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata
JapanAktiv, nicht rekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Tokyo
JapanRekrutierend» Google-Maps
Juntendo University Hospital
113-8431 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Tokyo
JapanRekrutierend» Google-Maps
Tokyo Medical University Hospital
160-0023 Tokyo
JapanRekrutierend» Google-Maps
Wakayama Medical University Hospital
641-8510 Wakayama
JapanRekrutierend» Google-Maps
National Hospital Organization Yamaguchi - Ube Medical Center
755-0241 Yamaguchi
JapanRekrutierend» Google-Maps
Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department
050022 Almaty
KazakhstanRekrutierend» Google-Maps
Almaty Cancer Hospital; Chemotherapy department
050054 Almaty
KazakhstanAktiv, nicht rekrutierend» Google-Maps
Multidisciplinary medical center; Chemotherapy department
010000 Astana
KazakhstanRekrutierend» Google-Maps
Chungbuk National University Hospital
28644 Cheongju-si
Korea, Republic ofRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Ajou University Medical Center
16499 Gyeonggi-do
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofRekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Jeollanam-do
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13605 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
(0)6351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Korea University Guro Hospital
08308 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Riga East Clinical University Hospital Latvian Oncology Centre
LV-1079 Riga
LatviaRekrutierend» Google-Maps
American University of Beirut - Medical Center
1107 2020 Beirut
LebanonNoch nicht rekrutierend» Google-Maps
PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax
1000 Skopje
North MacedoniaRekrutierend» Google-Maps
Private Health Organization Acibadem Sistina Hospital
1000 Skopje
North MacedoniaRekrutierend» Google-Maps
Gdanski Uniwersytet Medyczny; Katedra i Klinika Onkologii i Radioterapii
80-214 Gdańsk
PolandRekrutierend» Google-Maps
Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol.
31-202 Kraków
PolandRekrutierend» Google-Maps
Samodzielny Publiczny Szpital Wojewodzki im. Jana Bozego w Lublinie; Oddzial Chorob Pluc i Gruzlicy
20-089 Lublin
PolandZurückgezogen» Google-Maps
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial onkologii z pododdzialem chemioterapii
10-357 Olsztyn
PolandRekrutierend» Google-Maps
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
60-569 Poznan
PolandRekrutierend» Google-Maps
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
02-781 Warszawa
PolandRekrutierend» Google-Maps
Dolnoslaskie Centrum Chorob Pluc we Wroclawiu
53-439 Wrocław
PolandRekrutierend» Google-Maps
CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo
3000-075 Coimbra
PortugalRekrutierend» Google-Maps
Hospital Pulido Valente; Servico de Pneumologia
1796-001 Lisboa
PortugalRekrutierend» Google-Maps
IPO do Porto; Servico de Oncologia Medica
4200-072 Porto
PortugalRekrutierend» Google-Maps
CHVNG/E_Unidade 1; Servico de Pneumologia
4434-502 Vila Nova De Gaia
PortugalRekrutierend» Google-Maps
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu; Oncologie Medicala II
022328 Bucuresti
RomaniaZurückgezogen» Google-Maps
Cardiomed Medical Center
400015 Cluj-Napoca
RomaniaRekrutierend» Google-Maps
Prof Dr I Chiricuta Institute of Oncology; Oncology Department
400015 Cluj-napoca
RomaniaRekrutierend» Google-Maps
Municipal Clinical Emergency Hospital Timisoara; Medical Oncology Clinic
300595 Timişoara
RomaniaRekrutierend» Google-Maps
Moscow City Oncology Hospital #62
143423 Moscovskaya Oblast
Russian FederationRekrutierend» Google-Maps
University сlinic of headaches
121467 Moscow
Russian FederationRekrutierend» Google-Maps
GUZ Regional clinical hospital # 1
350086 Krasnodar
Russian FederationRekrutierend» Google-Maps
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
115478 Moscow
Russian FederationRekrutierend» Google-Maps
P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept
125284 Moscow
Russian FederationRekrutierend» Google-Maps
City Clinical Hospital No. 1
630047 Novosibirsk
Russian FederationRekrutierend» Google-Maps
Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis
249036 Obninsk
Russian FederationZurückgezogen» Google-Maps
Pavlov First Saint Petersburg State Medical University
197022 St. Petersburg
Russian FederationRekrutierend» Google-Maps
SPb City Clin Onc Dsp; Chemotherapy
197022 St. Petersburg
Russian FederationRekrutierend» Google-Maps
Scientific Research Oncology Institute named after N.N. Petrov; Oncology
197758 St. Petersburg
Russian FederationRekrutierend» Google-Maps
King Faisal Specialist Hospital & Research Centre; Oncology
11211 Riyadh
Saudi ArabiaRekrutierend» Google-Maps
National Cancer Centre; Medical Oncology
169610 Singapore
SingaporeRekrutierend» Google-Maps
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
08916 Badalona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Donostia: Oncology Service
20014 Donostia-san Sebastian
SpainRekrutierend» Google-Maps
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
28222 Majadahonda
SpainRekrutierend» Google-Maps
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
08028 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron; Oncology
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
08041 Barcelona
SpainRekrutierend» Google-Maps
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
15006 La Coruña
SpainRekrutierend» Google-Maps
Hospital Clinico San Carlos; Servicio de Oncologia
28040 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre; Servicio de Oncologia
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario La Paz; Servicio de Oncologia
28046 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
HM Sanchinarro - CIOCC; Servicio de Oncologia
28050 Madrid
SpainRekrutierend» Google-Maps
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
29010 Malaga
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
41013 Sevilla
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
46010 Valencia
SpainRekrutierend» Google-Maps
Hospital Universitari i Politecnic La Fe; Oncologia
46026 Valencia
SpainRekrutierend» Google-Maps
Kaohsiung Medical University Chung-Ho Memorial Hospital
807 Kaohsiung City
TaiwanRekrutierend» Google-Maps
Chang Gung Memorial Foundation - Kaohsiung
00833 Kaohsiung
TaiwanRekrutierend» Google-Maps
China Medical University Hospital
40447 Taichung
TaiwanRekrutierend» Google-Maps
Taichung Veterans General Hospital
407 Taichung
TaiwanRekrutierend» Google-Maps
National Cheng Kung University Hospital
70457 Tainan
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
112 Taipei
TaiwanRekrutierend» Google-Maps
Chang Gung Medical Foundation - Linkou; Chest Dept
333 Taoyuan
TaiwanRekrutierend» Google-Maps
Chulalongkorn Hospital; Medical Oncology
10330 Bangkok
ThailandRekrutierend» Google-Maps
Ramathibodi Hospital; Medicine/Oncology
10400 Bangkok
ThailandAktiv, nicht rekrutierend» Google-Maps
Siriraj Hospital; Medical Oncology Unit
10700 Bangkok
ThailandRekrutierend» Google-Maps
Maharaj Nakorn Chiang Mai Hospital; Department of Medicine
50200 ChiangMai
ThailandZurückgezogen» Google-Maps
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
01250 Adana
TurkeyRekrutierend» Google-Maps
Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic
06200 Ankara
TurkeyZurückgezogen» Google-Maps
Ufuk University Dr. Rıdvan Ege Health Research and Implementation Hospital; Oncology Departmant
06300 Ankara
TurkeyZurückgezogen» Google-Maps
Ankara Ataturk Chest Diseases Training and Research Hospital
06500 Ankara
TurkeyRekrutierend» Google-Maps
Medipol University MF; Oncology Department
34214 Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
34300 Istanbul
TurkeyRekrutierend» Google-Maps
Ege Uni Medical Faculty Hospital; Oncology Dept
35100 Izmir
TurkeyRekrutierend» Google-Maps
Izmir Suat Seren Chest Diseases and Surgery Research Hospital
35110 Izmir
TurkeyRekrutierend» Google-Maps
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
44280 Malatya
TurkeyRekrutierend» Google-Maps
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
06230 Sihhiye/Ankara
TurkeyAktiv, nicht rekrutierend» Google-Maps
Sureyyapasa Göğüs Hastalıkları ve Göğüs Cerrahisi Egitim ve Araştırma Hastanesi; Göğüs Hastalıkları
34844 Yali
TurkeyRekrutierend» Google-Maps
Medical Center "Adonis" LLC
08112 Kapitanovka Village
UkraineRekrutierend» Google-Maps
Chemotherapy SI Dnipropetrovsk MA of MOHU
49102 Dnipropetrovsk
UkraineRekrutierend» Google-Maps
National Cancer Institute MOH of Ukraine
36022 Kiev
UkraineZurückgezogen» Google-Maps
Kyiv City Clinical Oncological Center
03115 Kyiv
UkraineRekrutierend» Google-Maps
RCI Sumy Regional Clinical Oncological Dispensary
40005 Sumy
UkraineRekrutierend» Google-Maps
Vinnytsia Regional Clinical Oncology Dispensary; Department of Chemotherapy
21029 Vinnytsia
UkraineRekrutierend» Google-Maps
MI of Zaporizhzhia Regional Council Zaporizhzhia Regional Clinical Oncology Dispensary; Thoracic
69040 Zaporizhzhia
UkraineZurückgezogen» Google-Maps
St Bartholomew's Hospital
EC1A 7BE London
United KingdomRekrutierend» Google-Maps
Guy's Hospital; Guy's Cancer Center
SE1 9RY London
United KingdomRekrutierend» Google-Maps
Wythenshaw Hospital
M23 9QZ Manchester
United KingdomRekrutierend» Google-Maps
Royal Preston Hospital; Lancashire Clinical Research Facility
PR2 9HT Preston
United KingdomZurückgezogen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This randomized, active-controlled, multicenter, open-label, Phase III study is designed to

investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant

setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice

daily (BID) taken with food for 24 months.

Participants in the control arm will receive one of the protocol specified platinum based

chemotherapy regimens for 4 cycles. Following treatment completion, participants will be

followed up for their disease until disease recurrence. At the time of disease recurrence,

participants will enter a survival follow-up until death, withdrawal of consent or study

closure, whichever occurs earlier.

Ein-/Ausschlusskriterien

Key Inclusion Criteria

- Age ≥18 years

- Complete resection of histologically confirmed Stage IB (tumor ≥ 4 cm) to Stage IIIA

(T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC as per Union Internationale Contre le

Cancer / American Joint Committee on Cancer, 7th edition, with negative margins, at

4-12 weeks before enrollment

- If mediastinoscopy was not performed preoperatively, it is expected that, at a

minimum, mediastinal lymph node systematic sampling will have occurred

- Documented ALK-positive disease according to an FDA-approved and CE-marked test

- Eligible to receive a platinum-based chemotherapy regimen according to the local

labels or guidelines

- Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1

- Adequate hematologic and renal function

- For women of childbearing potential: agreement to remain abstinent or use

contraceptive methods with a failure rate of < 1% per year during the treatment period

and for at least 90 days after the last dose of alectinib or according to local labels

or guidelines for chemotherapy

- For men: agreement to remain abstinent or use contraceptive measures, and agreement to

refrain from donating sperm for at least 90 days after the last dose of alectinib or

according to local labels or guidelines for chemotherapy. Men must refrain from

donating sperm during this same period

- Willingness and ability to comply with scheduled visits, treatment plans, laboratory

tests, and other study procedures

Key Exclusion Criteria

- Pregnant or breastfeeding, or intending to become pregnant during the study or within

90 days after the last dose of alectinib or according to local labels or guidelines

for chemotherapy

- Prior adjuvant radiotherapy for NSCLC

- Prior exposure to systemic chemotherapy and ALK inhibitors

- Stage IIIA N2 patients that, in the investigator's opinion, should receive

post-operative radiotherapy treatment are excluded from the study

- Known sensitivity to any component of study drug to which the patient may be

randomized. This includes, but is not limited to, patients with galactose intolerance,

a congenital lactase deficiency or glucose-galactose malabsorption.

- Malignancies other than NSCLC within 5 years prior to enrollment, except for

curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI)

cancer by endoscopic resection, in situ carcinoma of the cervix, ductal carcinoma in

situ, papillary thyroid cancer, or any cured cancer that is considered to have no

impact on disease free survival or overall survival for the current NSCLC

- Any GI disorder that may affect absorption of oral medications, such as malabsorption

syndrome or status post-major bowel resection

- Liver disease characterized by aspartate transaminase and alanine transaminase >= 3 ×

upper limit of normal or impaired excretory function or synthetic function or other

conditions of decompensated liver disease such as coagulopathy, hepatic

encephalopathy, hypoalbuminemia, ascites, or bleeding from esophageal varices or

active viral or active autoimmune, alcoholic, or other types of acute hepatitis

- Japanese patients participating in the serial/intensive PK sample collection only:

administration of strong/potent CYP450 3A inhibitors or inducers within 14 days prior

to the first dose of study treatment and while on treatment with alectinib up to Week

3

- Any exclusion criteria based on the local labels or guidelines for chemotherapy

regimen

- Patients with symptomatic bradycardia

- History of organ transplant

- Known HIV positivity or AIDS-related illness

- Any clinically significant concomitant disease or condition that could interfere

with-or for which the treatment might interfere with the conduct of the study or the

absorption of oral medications or that would pose an unacceptable risk to the patients

in this study, in the opinion of the Principal Investigator

- Any psychological, familial, sociological, or geographical condition potentially

hampering compliance with the study protocol requirements and/or follow-up procedures;

those conditions should be discussed with the patient before trial entry

Studien-Rationale

Primary outcome:

1. Disease-free Survival (DFS), as Assessed by the Investigator (Time Frame - From the date of randomization until the first DFS event, up to approximately 5 years):
DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first



Secondary outcome:

1. Overall Survival (OS) (Time Frame - From the date of randomization until death due to any cause up to approximately 8 years):
Primary OS analysis at approximately 5 years after FPI and final OS analysis at approximately 8 years after FPI. OS, defined as the time from randomization to death from any cause.

2. Plasma Concentration of Alectinib (Time Frame - Predose (2 hours) at Baseline, Week 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, and 96)

3. Plasma Concentration of Alectinib metabolite (Time Frame - Predose (2 hours) at Baseline, Week 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, and 96)

4. Percentage of Participants with Adverse Advent (Time Frame - From the date of randomization up to approximately 2 years):
Incidence of Adverse Events, with Severity Determined Through Use of National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 Safety Laboratory Values, Vital Signs, ECG

Studien-Arme

  • Experimental: Alectinib
  • Active Comparator: Platinum-Based Chemotherapy

Geprüfte Regime

  • Alectnib (RO5424802):
    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.
  • 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."
  • Vinorelbine (Navelbine):
    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.
  • Gemcitabine (Gitrabin):
    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.
  • Pemetrexed (Alimta®):
    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."
  • Carboplatin:
    For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.

Quelle: ClinicalTrials.gov


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