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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456076
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Alectnib Drug: Cisplatin Drug: Vinorelbine Drug: Gemcitabine Drug: Pemetrexed Drug: Carboplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : August 13, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Alectinib

Arm Intervention/treatment
Experimental: Alectinib 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.
Other Name: RO5424802

Active Comparator: Platinum-Based Chemotherapy 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.
Other Name: Navelbine

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.
Other Name: Gitrabin

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."
Other Name: Alimta®

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




Primary Outcome Measures :
  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 Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 acute 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456076


Contacts
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Contact: Reference Study ID Number: BO40336 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Locations
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United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
United States, Massachusetts
MGH Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Withdrawn
Ann Arbor, Michigan, United States, 48109-0934
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
Northern Cancer Institute Recruiting
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Sunshine Coast University Hospital; The Adem Crosby Centre Not yet recruiting
Birtinya, Queensland, Australia, 4575
Cairns Base Hospital; Cancer Care Centre Not yet recruiting
Cairns, Queensland, Australia, 4870
Townsville Hospital Recruiting
Townsville, Queensland, Australia, 4810
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Peter MacCallum Cancer Center Recruiting
Melbourne, Victoria, Australia, 3000
Austria
Klinikum Wels-Grieskirchen; Lungenabt. Recruiting
Wels, Austria, 4600
Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie Recruiting
Wien, Austria, 1210
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska; Clinic for Pulmonary Diseases Recruiting
Banja Luka, Bosnia and Herzegovina, 78000
Uni Hospital Mostar Recruiting
Mostar, Bosnia and Herzegovina, 88000
Clinic of Oncology, University Clinical Center Sarajevo Recruiting
Sarajevo, Bosnia and Herzegovina, 7100
University Clinical Center Tuzla; Clinic for Pulmonary Diseases Recruiting
Tuzla, Bosnia and Herzegovina, 75000
China
Anhui Provincial Hospital Withdrawn
Anhui, China, 230001
Beijing Cancer Hospital Not yet recruiting
Beijing, China, 100142
Jilin Cancer Hospital Not yet recruiting
Changchun, China, 130012
Fujian Medical University Union Hospital Not yet recruiting
Fujian, China, 350001
Guangdong General Hospital Not yet recruiting
Guangzhou, China, 510080
Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, China, 310022
Shanghai Chest Hospital Not yet recruiting
Shanghai, China, 200000
Zhongshan Hospital Fudan University Not yet recruiting
Shanghai, China, 200032
Liaoning Provincial Cancer Hospital Not yet recruiting
Shengyang, China, 110042
First Affiliated Hospital of Soochow University Not yet recruiting
Suzhou, China, 215006
Union Hospital Tongji Medical College Huazhong University of Science and Technology Not yet recruiting
Wuhan City, China, 430023
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital) Not yet recruiting
Xi'an, China, 710038
Denmark
Odense Universitetshospital, Onkologisk Afdeling R Recruiting
Odense C, Denmark, 5000
Egypt
Kasr Eieny Uni Hospital; Oncology (Nemrock) Not yet recruiting
Cairo, Egypt, 11555
National Cancer Institute Not yet recruiting
Cairo, Egypt, 11796
France
CHU Angers Recruiting
Angers, France, 49933
Hopital Nord AP-HM Recruiting
Marseille, France, 13015
Hôpital Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Hopital Bichat Claude Bernard; Oncologie Serv. Recruiting
Paris, France, 75018
Ch De Saint Quentin; Medecine B14 Recruiting
St Quentin, France, 02321
Hopitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Hopital Foch; Pneumologie Recruiting
Suresnes, France, 92151
Germany
Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo Withdrawn
Berlin, Germany, 13353
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Germany, 09116
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH Recruiting
Georgsmarienhütte, Germany, 49124
Thoraxklinik Heidelberg gGmbH Recruiting
Heidelberg, Germany, 69126
Fachklinik für Lungenerkrankungen Recruiting
Immenhausen, Germany, 34376
Lungenklinik Lostau Withdrawn
Lostau, Germany, 39291
Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie/Onkologie Recruiting
Paderborn, Germany, 33098
Greece
Uoa Sotiria Hospital; Oncology Recruiting
Athens, Greece, 115 27
Agioi Anargyroi; 3Rd Dept. of Medical Oncology Recruiting
Athens, Greece, 145 64
Euromedical General Clinic of Thessaloniki; Oncology Department Recruiting
Thessaloniki, Greece, 546 45
Hungary
Semmelweis Egyetem, AOK, Pulmonologiai Klinika Recruiting
Budapest, Hungary, 1083
Orszagos Onkologiai Intezet Recruiting
Budapest, Hungary, 1122
University of Pecs; 1St Department of Medicine Recruiting
Pecs, Hungary, 7623
Hetenyi Geza County Hospital; Onkologiai Kozpont Recruiting
Szolnok, Hungary, 5004
Israel
Soroka Medical Center Recruiting
Beer Sheva, Israel, 8410101
Rambam Health Care Campus; Oncology Recruiting
Haifa, Israel, 3109601
Meir Medical Center Recruiting
Kfar- Saba, Israel, 4428164
Rabin MC- Belinson campus Recruiting
Petach Tikva, Israel, 49100
Sheba Medical Center Recruiting
Ramat Gan, Israel, 5262100
Italy
Az. Osp. Monaldi; 1 Pneumologia Oncologica Recruiting
Napoli, Campania, Italy, 80131
Azienda Osp. Univ di Modena; Dept Onc & Hem Recruiting
Modena, Emilia-Romagna, Italy, 41100
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica Recruiting
Ravenna, Emilia-Romagna, Italy, 48100
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica Recruiting
Aviano, Friuli-Venezia Giulia, Italy, 33081
Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1 Recruiting
Roma, Lazio, Italy, 00151
A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia Recruiting
Cremona, Lombardia, Italy, 26100
Irccs Ospedale San Raffaele;Oncologia Medica Recruiting
Milano, Lombardia, Italy, 20132
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia Recruiting
Milano, Lombardia, Italy, 20141
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico Recruiting
Orbassano, Piemonte, Italy, 10043
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii Recruiting
Pisa, Toscana, Italy, 56124
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica Recruiting
Perugia, Umbria, Italy, 06156
Japan
Aichi Cancer Center Recruiting
Aichi, Japan, 464-8681
Fujita Health University Hospital Recruiting
Aichi, Japan, 470-1192
Chiba University Hospital Recruiting
Chiba, Japan, 260-8677
National Cancer Center Hospital East Recruiting
Chiba, Japan, 277-8577
Shikoku Cancer Center Recruiting
Ehime, Japan, 791-0280
National Hospital Organization Kyushu Cancer Center Recruiting
Fukuoka, Japan, 811-1395
Hiroshima University Hospital Recruiting
Hiroshima, Japan, 734-8551
National Hospital Organization Hokkaido Cancer Center Recruiting
Hokkaido, Japan, 003-0804
Hyogo College of Medicine Hospital Recruiting
Hyogo, Japan, 663-8501
National Hospital Organization Himeji Medical Center Recruiting
Hyogo, Japan, 670-8520
Kanagawa Cancer Center Recruiting
Kanagawa, Japan, 241-8515
Kumamoto University Hospital Recruiting
Kumamoto, Japan, 860-8556
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Sendai Kousei Hospital Recruiting
Miyagi, Japan, 980-0873
Niigata Cancer Center Hospital Recruiting
Niigata, Japan, 951-8566
Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
Osaka City General Hospital Recruiting
Osaka, Japan, 534-0021
Kindai University Hospital Recruiting
Osaka, Japan, 589-8511
Saitama Cancer Center Recruiting
Saitama, Japan, 362-0806
Shizuoka Cancer Center Active, not recruiting
Shizuoka, Japan, 411-8777
National Cancer Center Hospital Recruiting
Tokyo, Japan, 104-0045
Juntendo University Hospital Recruiting
Tokyo, Japan, 113-8431
The Cancer Institute Hospital of JFCR Recruiting
Tokyo, Japan, 135-8550
Tokyo Medical University Hospital Recruiting
Tokyo, Japan, 160-0023
Wakayama Medical University Hospital Recruiting
Wakayama, Japan, 641-8509
National Hospital Organization Yamaguchi - Ube Medical Center Recruiting
Yamaguchi, Japan, 775-0241
Kazakhstan
Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department Recruiting
Almaty, Kazakhstan, 050022
Almaty Cancer Hospital; Chemotherapy department Recruiting
Almaty, Kazakhstan, 050054
Oncology centre of Astana; Chemotherapy department Not yet recruiting
Astana, Kazakhstan, 010000
Korea, Republic of
Chungbuk National University Hospital Not yet recruiting
Cheongju-si, Korea, Republic of, 28644
National Cancer Center Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 13620
Ajou University Medical Center Not yet recruiting
Gyeonggi-do, Korea, Republic of, 16499
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Asan Medical Center - Oncology Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 6351
Latvia
Riga East Clinical University Hospital Latvian Oncology Centre Recruiting
Riga, Latvia, LV-1079
North Macedonia
PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax Recruiting
Skopje, North Macedonia, 1000
Private Health Organization Acibadem Sistina Hospital Recruiting
Skopje, North Macedonia, 1000
Poland
Gdanski Uniwersytet Medyczny; Katedra i Klinika Onkologii i Radioterapii Recruiting
Gdańsk, Poland, 80-214
Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol. Not yet recruiting
Kraków, Poland, 31-202
Samodzielny Publiczny Szpital Wojewodzki im. Jana Bozego w Lublinie; Oddzial Chorob Pluc i Gruzlicy Withdrawn
Lublin, Poland, 20-089
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial onkologii z pododdzialem chemioterapii Recruiting
Olsztyn, Poland, 10-357
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu Recruiting
Poznan, Poland, 60-569
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie; Klinika Nowotworow Pluca i Klatki Piersiowej Recruiting
Warszawa, Poland, 02-781
Portugal
Hospital Geral; Servico de Pneumologia Recruiting
Coimbra, Portugal, 3041-801
Hospital Pulido Valente; Servico de Pneumologia Recruiting
Lisboa, Portugal, 1796-001
IPO do Porto; Servico de Oncologia Medica Recruiting
Porto, Portugal, 4200-072
CHVNG/E_Unidade 1; Servico de Pneumologia Recruiting
Vila Nova De Gaia, Portugal, 4434-502
Russian Federation
Moscow City Oncology Hospital #62 Recruiting
Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
University сlinic of headaches Recruiting
Moscow, Moskovskaja Oblast, Russian Federation, 121467
GUZ Regional clinical hospital # 1 Recruiting
Krasnodar, Russian Federation, 350086
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF Recruiting
Moscow, Russian Federation, 115478
P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept Recruiting
Moscow, Russian Federation, 125284
City Clinical Hospital No. 1 Recruiting
Novosibirsk, Russian Federation, 630047
Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis Withdrawn
Obninsk, Russian Federation, 249036
Pavlov First Saint Petersburg State Medical University Not yet recruiting
St. Petersburg, Russian Federation, 197022
SPb City Clin Onc Dsp; Chemotherapy Recruiting
St. Petersburg, Russian Federation, 197022
Scientific Research Oncology Institute named after N.N. Petrov; Oncology Recruiting
St. Petersburg, Russian Federation, 197758
Saudi Arabia
King Faisal Specialist Hospital & Research Centre; Oncology Not yet recruiting
Riyadh, Saudi Arabia, 11211
Singapore
National Cancer Centre; Medical Oncology Recruiting
Singapore, Singapore, 169610
Tan Tock Seng Hospital Recruiting
Singapore, Singapore, 308433
South Africa
The Oncology Center Recruiting
Durban, South Africa, 4091
Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia Recruiting
Badalona, Barcelona, Spain, 08916
Hospital Universitario Donostia: Oncology Service Recruiting
Donostia, Guipuzcoa, Spain, 20080
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica Recruiting
Barcelona, Spain, 08028
Hospital Universitari Vall d'Hebron; Oncology Recruiting
Barcelona, Spain, 08035
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia Recruiting
Barcelona, Spain, 08041
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología Recruiting
La Coruña, Spain, 15006
Hospital Clinico San Carlos; Servicio de Oncologia Recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre; Servicio de Oncologia Recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Oncologia Recruiting
Madrid, Spain, 28046
HM Sanchinarro - CIOCC; Servicio de Oncologia Recruiting
Madrid, Spain, 28050
Hospital Universitario Puerta de Hierro; Servicio de Oncologia Recruiting
Madrid, Spain, 28222
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia Recruiting
Malaga, Spain, 29010
Hospital Universitario Virgen del Rocio; Servicio de Oncologia Recruiting
Sevilla, Spain, 41013
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia Recruiting
Valencia, Spain, 46010
Hospital Universitari i Politecnic La Fe; Oncologia Recruiting
Valencia, Spain, 46026
Taiwan
Chang Gung Memorial Foundation - Kaohsiung Recruiting
Kaohsiung, Taiwan, 00833
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 407
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 70457
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology Recruiting
Taipei, Taiwan, 112
Chang Gung Medical Foundation - Linkou; Chest Dept Recruiting
Taoyuan, Taiwan, 333
Thailand
Chulalongkorn Hospital; Medical Oncology Recruiting
Bangkok, Thailand, 10330
Ramathibodi Hospital; Medicine/Oncology Active, not recruiting
Bangkok, Thailand, 10400
Siriraj Hospital; Medical Oncology Unit Recruiting
Bangkok, Thailand, 10700
Maharaj Nakorn Chiang Mai Hospital; Department of Medicine Recruiting
ChiangMai, Thailand, 50200
Turkey
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology Recruiting
Adana, Turkey, 01250
Hacettepe Uni Medical Faculty Hospital; Oncology Dept Recruiting
Ankara, Turkey, 06100
Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic Terminated
Ankara, Turkey, 06200
Ufuk University Dr. Rıdvan Ege Health Research and Implementation Hospital; Oncology Departmant Recruiting
Ankara, Turkey, 06300
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology Recruiting
Istanbul, Turkey, 34300
Ege Uni Medical Faculty Hospital; Oncology Dept Not yet recruiting
Izmir, Turkey, 35100
Izmir Suat Seren Chest Diseases and Surgery Research Hospital Recruiting
Izmir, Turkey, 35110
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department Recruiting
Malatya, Turkey, 44280
Medikal Park Samsun Recruiting
Samsun, Turkey, 55200
Ukraine
Medical Center "Adonis" LLC Recruiting
Kapitanovka Village, KIEV Governorate, Ukraine, 08112
CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU Recruiting
Dnipropetrovsk, Ukraine, 49102
National Cancer Institute MOH of Ukraine Terminated
Kiev, Ukraine, 36022
Kyiv City Clinical Oncological Center Recruiting
Kyiv, Ukraine, 03115
RCI Sumy Regional Clinical Oncological Dispensary Recruiting
Sumy, Ukraine, 40005
Vinnytsia Regional Clinical Oncology Dispensary; Department of Chemotherapy Recruiting
Vinnytsia, Ukraine, 21029
MI of Zaporizhzhia Regional Council Zaporizhzhia Regional Clinical Oncology Dispensary; Thoracic Withdrawn
Zaporizhzhia, Ukraine, 69040
United Kingdom
St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Guy's Hospital; Guy's Cancer Center Recruiting
London, United Kingdom, SE1 9RY
Wythenshaw Hospital Recruiting
Manchester, United Kingdom, M23 9QZ
Royal Preston Hospital; Lancashire Clinical Research Facility Recruiting
Preston, United Kingdom, PR2 9HT
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03456076     History of Changes
Other Study ID Numbers: BO40336
2017-004331-37 ( EudraCT Number )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
NSCLC, alectinib, ALK positive,adjuvant treatment, platinum based chemotherapy, complete resection, Stage IB-IIIA.
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Carboplatin
Pemetrexed
Vinorelbine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents