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

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

NCT ID: NCT03456076

Condition: Carcinoma, Non-Small-Cell Lung

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Carboplatin
Gemcitabine
Pemetrexed
Vinorelbine
Alectinib

Conditions: Keywords:
NSCLC, alectinib, ALK positive,adjuvant treatment, platinum based chemotherapy, complete resection, Stage IB-IIIA.

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Alectnib
Description: 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.
Arm group label: Alectinib

Other name: RO5424802

Intervention type: Drug
Intervention name: Cisplatin
Description: 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."
Arm group label: Platinum-Based Chemotherapy

Intervention type: Drug
Intervention name: Vinorelbine
Description: 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.
Arm group label: Platinum-Based Chemotherapy

Other name: Navelbine

Intervention type: Drug
Intervention name: Gemcitabine
Description: 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.
Arm group label: Platinum-Based Chemotherapy

Other name: Gitrabin

Intervention type: Drug
Intervention name: Pemetrexed
Description: 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."
Arm group label: Platinum-Based Chemotherapy

Other name: Alimta®

Intervention type: Drug
Intervention name: Carboplatin
Description: For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.
Arm group label: Platinum-Based Chemotherapy

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.

Criteria for eligibility:
Criteria:
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 anti-cancer therapy 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Rush University Medical Center

Address:
City: Chicago
Zip: 60612
Country: United States

Facility:
Name: MGH Cancer Center

Address:
City: Boston
Zip: 02114
Country: United States

Facility:
Name: Allegheny General Hospital

Address:
City: Pittsburgh
Zip: 15212
Country: United States

Facility:
Name: Chris O'Brien Lifehouse

Address:
City: Camperdown
Zip: 2050
Country: Australia

Facility:
Name: Northern Cancer Institute

Address:
City: St Leonards
Zip: 2065
Country: Australia

Facility:
Name: Peter MacCallum Cancer Center

Address:
City: North Melbourne
Zip: 3051
Country: Australia

Facility:
Name: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

Address:
City: Wien
Zip: 1210
Country: Austria

Facility:
Name: Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary?

Address:
City: Gomel
Zip: 246012
Country: Belarus

Facility:
Name: Healthcare Institution Grodno University Hospital; Regional Oncologic Dispensary

Address:
City: Grodno
Zip: 230030
Country: Belarus

Facility:
Name: Vitebsk Regional Clinical Oncology Dispensary

Address:
City: Vitebsk
Zip: BU-210603
Country: Belarus

Facility:
Name: Clinical center University of Sarajevo

Address:
City: Sarajevo
Zip: 71000
Country: Bosnia and Herzegovina

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Jilin Cancer Hospital

Address:
City: Changchun
Zip: 132013
Country: China

Facility:
Name: West China Hospital, Sichuan University

Address:
City: Chengdu
Zip: 610041
Country: China

Facility:
Name: Fujian Medical University Union Hospital

Address:
City: Fuzhou City
Zip: 350001
Country: China

Facility:
Name: Guangdong General Hospital

Address:
City: Guangzhou
Zip: 510080
Country: China

Facility:
Name: Shandong Cancer Hospital

Address:
City: Jinan
Zip: 250117
Country: China

Facility:
Name: Shanghai Chest Hospital

Address:
City: Shanghai
Zip: 200000
Country: China

Facility:
Name: Zhongshan Hospital Fudan University

Address:
City: Shanghai
Zip: 200032
Country: China

Facility:
Name: Shenzhen People's Hospital

Address:
City: Shenzhen
Zip: 510852
Country: China

Facility:
Name: Union Hospital Tongji Medical College Huazhong University of Science and Technology

Address:
City: Wuhan City
Zip: 430023
Country: China

Facility:
Name: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Address:
City: Xi'an
Zip: 710061
Country: China

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Zhejiang
Zip: 310022
Country: China

Facility:
Name: Odense Universitetshospital, Onkologisk Afdeling R

Address:
City: Odense C
Zip: 5000
Country: Denmark

Facility:
Name: Kasr Eieny Uni Hospital; Oncology (Nemrock)

Address:
City: Cairo
Zip: 11555
Country: Egypt

Facility:
Name: National Cancer Institute

Address:
City: Cairo
Zip: 11796
Country: Egypt

Facility:
Name: CHU Angers

Address:
City: Angers
Zip: 49933
Country: France

Facility:
Name: Hopital Nord AP-HM

Address:
City: Marseille
Zip: 13015
Country: France

Facility:
Name: Hôpital Arnaud de Villeneuve

Address:
City: Montpellier
Zip: 34295
Country: France

Facility:
Name: Hopital Bichat Claude Bernard; Oncologie Serv.

Address:
City: Paris
Zip: 75018
Country: France

Facility:
Name: Ch De Saint Quentin; Medecine B14

Address:
City: St Quentin
Zip: 02321
Country: France

Facility:
Name: Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie

Address:
City: Toulon
Zip: 83000
Country: France

Facility:
Name: Institut Gustave Roussy; Pathologie Thoracique

Address:
City: Villejuif cedex
Zip: 94805
Country: France

Facility:
Name: Klinikum Chemnitz gGmbH

Address:
City: Chemnitz
Zip: 09116
Country: Germany

Facility:
Name: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

Address:
City: Georgsmarienhütte
Zip: 49124
Country: Germany

Facility:
Name: Thoraxklinik Heidelberg gGmbH

Address:
City: Heidelberg
Zip: 69126
Country: Germany

Facility:
Name: Fachklinik für Lungenerkrankungen

Address:
City: Immenhausen
Zip: 34376
Country: Germany

Facility:
Name: Metropolitan Hospital

Address:
City: Athens
Zip: 185 47
Country: Greece

Facility:
Name: Theageneio Hospital

Address:
City: Thessaloniki
Zip: 546 39
Country: Greece

Facility:
Name: Semmelweis Egyetem, AOK, Pulmonologiai Klinika

Address:
City: Budapest
Zip: 1083
Country: Hungary

Facility:
Name: Orszagos Onkologiai Intezet

Address:
City: Budapest
Zip: 1122
Country: Hungary

Facility:
Name: University of Pecs; 1St Department of Medicine

Address:
City: Pecs
Zip: 7623
Country: Hungary

Facility:
Name: Hetenyi Geza County Hospital; Onkologiai Kozpont

Address:
City: Szolnok
Zip: 5004
Country: Hungary

Facility:
Name: Rambam Health Care Campus; Oncology

Address:
City: Haifa
Zip: 3109601
Country: Israel

Facility:
Name: Meir Medical Center

Address:
City: Kfar- Saba
Zip: 4428164
Country: Israel

Facility:
Name: Az. Osp. Monaldi; 1 Pneumologia Oncologica

Address:
City: Napoli
Zip: 80131
Country: Italy

Facility:
Name: Azienda Osp. Univ di Modena; Dept Onc & Hem

Address:
City: Modena
Zip: 41100
Country: Italy

Facility:
Name: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

Address:
City: Ravenna
Zip: 48100
Country: Italy

Facility:
Name: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

Address:
City: Aviano
Zip: 33081
Country: Italy

Facility:
Name: Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1

Address:
City: Roma
Zip: 00151
Country: Italy

Facility:
Name: A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia

Address:
City: Cremona
Zip: 26100
Country: Italy

Facility:
Name: Irccs Ospedale San Raffaele;Oncologia Medica

Address:
City: Milano
Zip: 20132
Country: Italy

Facility:
Name: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

Address:
City: Milano
Zip: 20141
Country: Italy

Facility:
Name: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

Address:
City: Orbassano
Zip: 10043
Country: Italy

Facility:
Name: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

Address:
City: Pisa
Zip: 56124
Country: Italy

Facility:
Name: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

Address:
City: Perugia
Zip: 06156
Country: Italy

Facility:
Name: Aichi Cancer Center

Address:
City: Aichi
Zip: 464-8681
Country: Japan

Facility:
Name: National Cancer Center Hospital East

Address:
City: Chiba
Zip: 277-8577
Country: Japan

Facility:
Name: National Hospital Organization Kyushu Cancer Center

Address:
City: Fukuoka
Zip: 811-1395
Country: Japan

Facility:
Name: Hiroshima University Hospital

Address:
City: Hiroshima
Zip: 734-8551
Country: Japan

Facility:
Name: National Hospital Organization Hokkaido Cancer Center

Address:
City: Hokkaido
Zip: 003-0804
Country: Japan

Facility:
Name: National Hospital Organization Himeji Medical Center

Address:
City: Hyogo
Zip: 670-8520
Country: Japan

Facility:
Name: Kanagawa Cancer Center

Address:
City: Kanagawa
Zip: 241-8515
Country: Japan

Facility:
Name: Kumamoto University Hospital

Address:
City: Kumamoto
Zip: 860-8556
Country: Japan

Facility:
Name: Kyoto University Hospital

Address:
City: Kyoto
Zip: 606-8507
Country: Japan

Facility:
Name: Sendai Kousei Hospital

Address:
City: Miyagi
Zip: 981-0914
Country: Japan

Facility:
Name: Niigata Cancer Center Hospital

Address:
City: Niigata
Zip: 951-8566
Country: Japan

Facility:
Name: Okayama University Hospital

Address:
City: Okayama
Zip: 700-8558
Country: Japan

Facility:
Name: Osaka City General Hospital

Address:
City: Osaka
Zip: 534-0021
Country: Japan

Facility:
Name: Shizuoka Cancer Center

Address:
City: Shizuoka
Zip: 411-8777
Country: Japan

Facility:
Name: National Cancer Center Hospital

Address:
City: Tokyo
Zip: 104-0045
Country: Japan

Facility:
Name: Juntendo University Hospital

Address:
City: Tokyo
Zip: 113-8431
Country: Japan

Facility:
Name: The Cancer Institute Hospital of JFCR

Address:
City: Tokyo
Zip: 135-8550
Country: Japan

Facility:
Name: Tokyo Medical University Hospital

Address:
City: Tokyo
Zip: 160-0023
Country: Japan

Facility:
Name: Almaty Oncology Center

Address:
City: Almaty
Zip: 050054
Country: Kazakhstan

Facility:
Name: National Cancer Center

Address:
City: Goyang-si
Zip: 10408
Country: Korea, Republic of

Facility:
Name: Ajou University Medical Center

Address:
City: Gyeonggi-do
Zip: 16499
Country: Korea, Republic of

Facility:
Name: Gachon University Gil Medical Center

Address:
City: Incheon
Zip: 21565
Country: Korea, Republic of

Facility:
Name: Chonnam National University Hwasun Hospital

Address:
City: Jeollanam-do
Zip: 58128
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seongnam-si
Zip: 463-707
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Korea University Guro Hospital

Address:
City: Seoul
Zip: 08308
Country: Korea, Republic of

Facility:
Name: PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax

Address:
City: Skopje
Zip: 1000
Country: North Macedonia

Facility:
Name: Private Health Organization Acibadem Sistina Hospital

Address:
City: Skopje
Zip: 1000
Country: North Macedonia

Facility:
Name: Gdanski Uniwersytet Medyczny; Katedra i Klinika Onkologii i Radioterapii

Address:
City: Gda?sk
Zip: 80-214
Country: Poland

Facility:
Name: Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol.

Address:
City: Kraków
Zip: 31-202
Country: Poland

Facility:
Name: Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

Address:
City: Olsztyn
Zip: 10-357
Country: Poland

Facility:
Name: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Address:
City: Poznan
Zip: 60-569
Country: Poland

Facility:
Name: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Facility:
Name: Dolnoslaskie Centrum Chorob Pluc we Wroclawiu

Address:
City: Wroc?aw
Zip: 53-439
Country: Poland

Facility:
Name: Cardiomed Medical Center

Address:
City: Cluj-Napoca
Zip: 400015
Country: Romania

Facility:
Name: Prof Dr I Chiricuta Institute of Oncology; Oncology Department

Address:
City: Cluj-napoca
Zip: 400015
Country: Romania

Facility:
Name: Oncomed SRL; Oncologie

Address:
City: Timisoara
Zip: 300239
Country: Romania

Facility:
Name: Moscow City Oncology Hospital #62

Address:
City: Moscovskaya Oblast
Zip: 143423
Country: Russian Federation

Facility:
Name: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

Address:
City: Moscow
Zip: 115478
Country: Russian Federation

Facility:
Name: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept

Address:
City: Moscow
Zip: 125284
Country: Russian Federation

Facility:
Name: SPb City Clin Onc Dsp; Chemotherapy

Address:
City: Sankt-peterburg
Zip: 197022
Country: Russian Federation

Facility:
Name: Pavlov First Saint Petersburg State Medical University

Address:
City: St. Petersburg
Zip: 197022
Country: Russian Federation

Facility:
Name: Scientific Research Oncology Institute named after N.N. Petrov; Oncology

Address:
City: St. Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: GUZ Regional clinical hospital # 1

Address:
City: Krasnodar
Zip: 350086
Country: Russian Federation

Facility:
Name: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

Address:
City: Badalona
Zip: 08916
Country: Spain

Facility:
Name: Hospital Universitario Donostia: Oncology Service

Address:
City: Donostia-san Sebastian
Zip: 20014
Country: Spain

Facility:
Name: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

Address:
City: Majadahonda
Zip: 28222
Country: Spain

Facility:
Name: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

Address:
City: Barcelona
Zip: 08028
Country: Spain

Facility:
Name: Hospital Universitari Vall d'Hebron; Oncology

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

Address:
City: Barcelona
Zip: 08041
Country: Spain

Facility:
Name: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

Address:
City: La Coruña
Zip: 15006
Country: Spain

Facility:
Name: Hospital Clinico San Carlos; Servicio de Oncologia

Address:
City: Madrid
Zip: 28040
Country: Spain

Facility:
Name: Hospital Universitario 12 de Octubre; Servicio de Oncologia

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Hospital Universitario La Paz; Servicio de Oncologia

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

Address:
City: Malaga
Zip: 29011
Country: Spain

Facility:
Name: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Address:
City: Sevilla
Zip: 41013
Country: Spain

Facility:
Name: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Address:
City: Valencia
Zip: 46010
Country: Spain

Facility:
Name: Hospital Universitari i Politecnic La Fe; Oncologia

Address:
City: Valencia
Zip: 46026
Country: Spain

Facility:
Name: Chang Gung Memorial Foundation - Kaohsiung

Address:
City: Kaohsiung
Zip: 00833
Country: Taiwan

Facility:
Name: China Medical University Hospital

Address:
City: Taichung
Zip: 40447
Country: Taiwan

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Zip: 10002
Country: Taiwan

Facility:
Name: Chang Gung Medical Foundation - Linkou; Chest Dept

Address:
City: Taoyuan
Zip: 333
Country: Taiwan

Facility:
Name: Taichung Veterans General Hospital

Address:
City: Xitun Dist.
Zip: 40705
Country: Taiwan

Facility:
Name: Chulalongkorn Hospital; Medical Oncology

Address:
City: Bangkok
Zip: 10330
Country: Thailand

Facility:
Name: Ramathibodi Hospital; Medicine/Oncology

Address:
City: Bangkok
Zip: 10400
Country: Thailand

Facility:
Name: Siriraj Hospital; Medical Oncology Unit

Address:
City: Bangkok
Zip: 10700
Country: Thailand

Facility:
Name: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

Address:
City: Adana
Zip: 01230
Country: Turkey

Facility:
Name: Ankara Ataturk Chest Diseases Training and Research Hospital

Address:
City: Ankara
Zip: 06500
Country: Turkey

Facility:
Name: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

Address:
City: Istanbul
Zip: 34300
Country: Turkey

Facility:
Name: Ege Uni Medical Faculty Hospital; Oncology Dept

Address:
City: Izmir
Zip: 35100
Country: Turkey

Facility:
Name: Izmir Suat Seren Chest Diseases and Surgery Research Hospital

Address:
City: Izmir
Zip: 35110
Country: Turkey

Facility:
Name: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

Address:
City: Malatya
Zip: 44280
Country: Turkey

Facility:
Name: Medikal Park Samsun

Address:
City: Samsun
Zip: 55200
Country: Turkey

Facility:
Name: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Address:
City: Sihhiye/Ankara
Zip: 06230
Country: Turkey

Facility:
Name: Medical center of Yuriy Spizhenko LLC

Address:
City: Kapitanovka Village
Zip: 08112
Country: Ukraine

Facility:
Name: Chemotherapy SI Dnipropetrovsk MA of MOHU

Address:
City: Dnipropetrovsk
Zip: 49102
Country: Ukraine

Facility:
Name: Kyiv City Clinical Oncological Center

Address:
City: Kyiv
Zip: 03115
Country: Ukraine

Facility:
Name: RCI Sumy Regional Clinical Oncological Dispensary

Address:
City: Sumy
Zip: 40005
Country: Ukraine

Facility:
Name: Vinnytsia Regional Clinical Oncology Dispensary; Department of Chemotherapy

Address:
City: Vinnytsia
Zip: 21029
Country: Ukraine

Facility:
Name: St Bartholomew's Hospital

Address:
City: London
Zip: EC1M 6BQ
Country: United Kingdom

Facility:
Name: Guys Hospital; Guys Cancer Center

Address:
City: London
Zip: SE1 9RT
Country: United Kingdom

Facility:
Name: Wythenshaw Hospital

Address:
City: Manchester
Zip: M23 9QZ
Country: United Kingdom

Start date: August 16, 2018

Completion date: November 19, 2026

Lead sponsor:
Agency: Hoffmann-La Roche
Agency class: Industry

Source: Hoffmann-La Roche

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT03456076