Clinical Trial - NCT03456076

       

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

Recruiting

Sponsor: Hoffmann-La Roche

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03456076

Protocol Info

Short Description: Phase III Alectinib VS Platinum-Based Chemotherapy in Anaplastic
Long Description: 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
MGH Status: Open
Sponsor: Hoffman-LaRoche
Disease Program: Thoracic

Next Steps


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Purpose

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 Title Intervention Phase
Carcinoma, Non-Small-Cell Lung Alectnib Cisplatin Vinorelbine Gemcitabine Pemetrexed Carboplatin Phase 3
Study Type Interventional
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

Primary Outcome Measures

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] [Designated as safety issue: ]


Secondary Outcome Measures

Overall Survival (OS) [Time Frame: From the date of randomization until death due to any cause up to approximately 8 years] [Designated as safety issue: ]

Plasma Concentration of Alectinib [Time Frame: Predose (2 hours) at Baseline, Week 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, and 96] [Designated as safety issue: ]

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] [Designated as safety issue: ]

Percentage of Participants with Adverse Advent [Time Frame: From the date of randomization up to approximately 2 years] [Designated as safety issue: ]

Estimated Enrollment: 255
Study Start Date: August 2018
Estimated Study Completion Date: November 2026
Estimated Primary Completion Date: June 2023
Arms Assigned Interventions

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.

Active Comparator:Platinum-Based Chemotherapy
Drug:Carboplatin
For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03456076

Locations

  • United States, Illinois
    • Rush University Medical Center Chicago, Illinois, United States, 60612
  • United States, Massachusetts
    • MGH Cancer Center Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • University of Michigan Ann Arbor, Michigan, United States, 48109-0934
  • United States, Pennsylvania
    • Allegheny General Hospital Pittsburgh, Pennsylvania, United States, 15212
  • Australia, New South Wales
    • Chris O'Brien Lifehouse Camperdown, New South Wales, Australia, 2050
    • Northern Cancer Institute St Leonards, New South Wales, Australia, 2065
  • Australia, Queensland
    • Sunshine Coast University Hospital; The Adem Crosby Centre Birtinya, Queensland, Australia, 4575
    • Cairns Base Hospital; Cancer Care Centre Cairns, Queensland, Australia, 4870
    • Townsville Hospital Townsville, Queensland, Australia, 4810
    • Princess Alexandra Hospital Woolloongabba, Queensland, Australia, 4102
  • Australia, Victoria
    • Peter MacCallum Cancer Center East Melbourne, Victoria, Australia, 3002
  • Austria,
    • Klinikum Wels-Grieskirchen; Lungenabt. Wels, , Austria, 4600
    • Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie Wien, , Austria, 1210
  • Belarus, Hrodzyenskaya Voblasts'
    • Healthcare Institution "Grodno Regional Clinical Hospital"; Regional Oncologic Dispensary Grodno, Hrodzyenskaya Voblasts', Belarus, 230030
  • Belarus,
    • State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology A/g Lesnoy, Minsk Region, , Belarus, 223040
    • Healthcare Institution "Gomel Regional Clinical Oncologic Dispensary" Gomel, , Belarus, 246012
    • Minsk City Clinical Oncologic Dispensary Minsk, , Belarus, BU-220013
    • Mogilev Regional Oncology Center Mogilev, , Belarus, 212018
    • Vitebsk Regional Clinical Oncology Dispensary Vitebsk, , Belarus, BU-210603
  • Bosnia and Herzegovina,
    • University Clinical Centre of the Republic of Srpska; Clinic for Pulmonary Diseases Banja Luka, , Bosnia and Herzegovina, 78000
    • Uni Hospital Mostar Mostar, , Bosnia and Herzegovina, 88000
    • Clinic of Oncology, University Clinical Center Sarajevo Sarajevo, , Bosnia and Herzegovina, 7100
    • University Clinical Center Tuzla; Clinic for Pulmonary Diseases Tuzla, , Bosnia and Herzegovina, 75000
  • China,
    • Beijing Cancer Hospital Beijing, , China, 100142
    • Jilin Cancer Hospital Changchun, , China, 132013
    • West China Hospital, Sichuan University Chengdu, , China, 610041
    • Fujian Medical University Union Hospital Fujian, , China, 350001
    • Guangdong General Hospital Guangzhou, , China, 510080
    • Anhui Provincial Hospital Hefei, , China, 230001
    • Yunnan Cancer Hospital Kunming, , China, 650118
    • Shanghai Chest Hospital Shanghai, , China, 200000
    • Zhongshan Hospital Fudan University Shanghai, , China, 200032
    • Liaoning Provincial Cancer Hospital Shengyang, , China, 110042
    • Shenzhen People's Hospital Shenzhen, , China, 510852
    • First Affiliated Hospital of Soochow University Suzhou, , China, 215006
    • Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan City, , China, 430023
    • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital) Xi'an, , China, 710038
    • First Affiliated Hospital of Medical College of Xi'an Jiaotong University Xi'an, , China, 710061
    • Zhejiang Cancer Hospital Zhejiang, , China, 310022
  • Denmark,
    • Odense Universitetshospital, Onkologisk Afdeling R Odense C, , Denmark, 5000
  • Egypt,
    • Kasr Eieny Uni Hospital; Oncology (Nemrock) Cairo, , Egypt, 11555
    • National Cancer Institute Cairo, , Egypt, 11796
    • Mansoura University; Oncology center Mansoura, , Egypt, 35111
  • France,
    • CHU Angers Angers, , France, 49933
    • Hopital Nord AP-HM Marseille, , France, 13015
    • Hôpital Arnaud de Villeneuve Montpellier, , France, 34295
    • Hopital Bichat Claude Bernard; Oncologie Serv. Paris, , France, 75018
    • Ch De Saint Quentin; Medecine B14 St Quentin, , France, 02321
    • Hopitaux Universitaires de Strasbourg Strasbourg, , France, 67091
    • Hopital Foch; Pneumologie Suresnes, , France, 92151
    • Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie Toulon, , France, 83000
    • Institut Gustave Roussy; Pathologie Thoracique Villejuif cedex, , France, 94805
  • Germany,
    • Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo Berlin, , Germany, 13353
    • Klinikum Chemnitz gGmbH Chemnitz, , Germany, 09116
    • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH Georgsmarienhütte, , Germany, 49124
    • Thoraxklinik Heidelberg gGmbH Heidelberg, , Germany, 69126
    • Fachklinik für Lungenerkrankungen Immenhausen, , Germany, 34376
    • Lungenklinik Lostau Lostau, , Germany, 39291
    • Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie/Onkologie Paderborn, , Germany, 33098
  • Greece,
    • General Hospital "G.Papanikolaou"; Pulmonogy Clinic Asvestochori, , Greece, 570 10
    • Uoa Sotiria Hospital; Oncology Athens, , Greece, 115 27
    • Metropolitan Hospital Athens, , Greece, 185 47
    • Theageneio Hospital Thessaloniki, , Greece, 54007
    • Euromedical General Clinic of Thessaloniki; Oncology Department Thessaloniki, , Greece, 546 45
  • Hungary,
    • Semmelweis Egyetem, AOK, Pulmonologiai Klinika Budapest, , Hungary, 1083
    • Orszagos Onkologiai Intezet Budapest, , Hungary, 1122
    • University of Pecs; 1St Department of Medicine Pecs, , Hungary, 7623
    • Hetenyi Geza County Hospital; Onkologiai Kozpont Szolnok, , Hungary, 5004
  • Israel,
    • Soroka Medical Center Beer Sheva, , Israel, 8410101
    • Rambam Health Care Campus; Oncology Haifa, , Israel, 3109601
    • Meir Medical Center Kfar- Saba, , Israel, 4428164
    • Rabin MC- Belinson campus Petach Tikva, , Israel, 4941492
    • Sheba Medical Center Ramat Gan, , Israel, 5262100
  • Italy, Campania
    • Az. Osp. Monaldi; 1 Pneumologia Oncologica Napoli, Campania, Italy, 80131
  • Italy, Emilia-Romagna
    • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica Bologna, Emilia-Romagna, Italy, 40138
    • Azienda Osp. Univ di Modena; Dept Onc & Hem Modena, Emilia-Romagna, Italy, 41100
    • Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica Ravenna, Emilia-Romagna, Italy, 48100
  • Italy, Friuli-Venezia Giulia
    • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica Aviano, Friuli-Venezia Giulia, Italy, 33081
  • Italy, Lazio
    • Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1 Roma, Lazio, Italy, 00151
  • Italy, Lombardia
    • A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia Cremona, Lombardia, Italy, 26100
    • Irccs Ospedale San Raffaele;Oncologia Medica Milano, Lombardia, Italy, 20132
    • Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia Milano, Lombardia, Italy, 20141
  • Italy, Piemonte
    • Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico Orbassano, Piemonte, Italy, 10043
  • Italy, Toscana
    • A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii Pisa, Toscana, Italy, 56124
  • Italy, Umbria
    • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica Perugia, Umbria, Italy, 06156
  • Japan,
    • Aichi Cancer Center Aichi, , Japan, 464-8681
    • Fujita Health University Hospital Aichi, , Japan, 470-1192
    • Chiba University Hospital Chiba, , Japan, 260-8677
    • National Cancer Center Hospital East Chiba, , Japan, 277-8577
    • Shikoku Cancer Center Ehime, , Japan, 791-0280
    • National Hospital Organization Kyushu Cancer Center Fukuoka, , Japan, 811-1395
    • Hiroshima University Hospital Hiroshima, , Japan, 734-8551
    • National Hospital Organization Hokkaido Cancer Center Hokkaido, , Japan, 003-0804
    • Hyogo College of Medicine Hospital Hyogo, , Japan, 663-8501
    • National Hospital Organization Himeji Medical Center Hyogo, , Japan, 670-8520
    • Kanagawa Cancer Center Kanagawa, , Japan, 241-8515
    • Kumamoto University Hospital Kumamoto, , Japan, 860-8556
    • Kyoto University Hospital Kyoto, , Japan, 606-8507
    • Sendai Kousei Hospital Miyagi, , Japan, 980-0873
    • Niigata Cancer Center Hospital Niigata, , Japan, 951-8566
    • Okayama University Hospital Okayama, , Japan, 700-8558
    • Osaka City General Hospital Osaka, , Japan, 534-0021
    • Kindai University Hospital Osaka, , Japan, 589-8511
    • Saitama Cancer Center Saitama, , Japan, 362-0806
    • Shizuoka Cancer Center Shizuoka, , Japan, 411-8777
    • National Cancer Center Hospital Tokyo, , Japan, 104-0045
    • Juntendo University Hospital Tokyo, , Japan, 113-8431
    • The Cancer Institute Hospital of JFCR Tokyo, , Japan, 135-8550
    • Tokyo Medical University Hospital Tokyo, , Japan, 160-0023
    • Wakayama Medical University Hospital Wakayama, , Japan, 641-8510
    • National Hospital Organization Yamaguchi - Ube Medical Center Yamaguchi, , Japan, 755-0241
  • Kazakhstan,
    • Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department Almaty, , Kazakhstan, 050022
    • Almaty Cancer Hospital; Chemotherapy department Almaty, , Kazakhstan, 050054
    • Multidisciplinary medical center; Chemotherapy department Astana, , Kazakhstan, 010000
  • Korea, Republic of,
    • Chungbuk National University Hospital Cheongju-si, , Korea, Republic of, 28644
    • National Cancer Center Goyang-si, , Korea, Republic of, 10408
    • Ajou University Medical Center Gyeonggi-do, , Korea, Republic of, 16499
    • Gachon University Gil Medical Center Incheon, , Korea, Republic of, 21565
    • Chonnam National University Hwasun Hospital Jeollanam-do, , Korea, Republic of, 58128
    • Seoul National University Bundang Hospital Seongnam-si, , Korea, Republic of, 13605
    • Samsung Medical Center Seoul, , Korea, Republic of, (0)6351
    • Asan Medical Center Seoul, , Korea, Republic of, 05505
    • Korea University Guro Hospital Seoul, , Korea, Republic of, 08308
  • Latvia,
    • Riga East Clinical University Hospital Latvian Oncology Centre Riga, , Latvia, LV-1079
  • Lebanon,
    • American University of Beirut - Medical Center Beirut, , Lebanon, 1107 2020
    • Mount Lebanon Hospital Beirut, , Lebanon, 1107 2090
  • North Macedonia,
    • PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax Skopje, , North Macedonia, 1000
    • Private Health Organization Acibadem Sistina Hospital Skopje, , North Macedonia, 1000
  • Poland,
    • Gdanski Uniwersytet Medyczny; Katedra i Klinika Onkologii i Radioterapii Gdansk, , Poland, 80-214
    • Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol. Kraków, , Poland, 31-202
    • Samodzielny Publiczny Szpital Wojewodzki im. Jana Bozego w Lublinie; Oddzial Chorob Pluc i Gruzlicy Lublin, , Poland, 20-089
    • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial onkologii z pododdzialem chemioterapii Olsztyn, , Poland, 10-357
    • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu Poznan, , Poland, 60-569
    • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers Warszawa, , Poland, 02-781
    • Dolnoslaskie Centrum Chorob Pluc we Wroclawiu Wroclaw, , Poland, 53-439
  • Portugal,
    • CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo Coimbra, , Portugal, 3000-075
    • Hospital Pulido Valente; Servico de Pneumologia Lisboa, , Portugal, 1796-001
    • IPO do Porto; Servico de Oncologia Medica Porto, , Portugal, 4200-072
    • CHVNG/E_Unidade 1; Servico de Pneumologia Vila Nova De Gaia, , Portugal, 4434-502
  • Romania,
    • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu; Oncologie Medicala II Bucuresti, , Romania, 022328
    • Cardiomed Medical Center Cluj-Napoca, , Romania, 400015
    • Prof Dr I Chiricuta Institute of Oncology; Oncology Department Cluj-napoca, , Romania, 400015
    • Oncomed SRL; Oncologie Timisoara, , Romania, 300239
    • Municipal Clinical Emergency Hospital Timisoara; Medical Oncology Clinic Timisoara, , Romania, 300595
  • Russian Federation, Moskovskaja Oblast
    • Moscow City Oncology Hospital #62 Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
    • University ¿linic of headaches Moscow, Moskovskaja Oblast, Russian Federation, 121467
  • Russian Federation,
    • GUZ Regional clinical hospital # 1 Krasnodar, , Russian Federation, 350086
    • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF Moscow, , Russian Federation, 115478
    • P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept Moscow, , Russian Federation, 125284
    • City Clinical Hospital No. 1 Novosibirsk, , Russian Federation, 630047
    • Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis Obninsk, , Russian Federation, 249036
    • Pavlov First Saint Petersburg State Medical University St. Petersburg, , Russian Federation, 197022
    • SPb City Clin Onc Dsp; Chemotherapy St. Petersburg, , Russian Federation, 197022
    • Scientific Research Oncology Institute named after N.N. Petrov; Oncology St. Petersburg, , Russian Federation, 197758
  • Saudi Arabia,
    • King Faisal Specialist Hospital & Research Centre; Oncology Riyadh, , Saudi Arabia, 11211
  • Singapore,
    • National Cancer Centre; Medical Oncology Singapore, , Singapore, 169610
    • Tan Tock Seng Hospital Singapore, , Singapore, 308433
  • South Africa,
    • The Oncology Center Durban, , South Africa, 4091
  • Spain, Barcelona
    • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia Badalona, Barcelona, Spain, 08916
  • Spain, Guipuzcoa
    • Hospital Universitario Donostia: Oncology Service Donostia-san Sebastian, Guipuzcoa, Spain, 20014
  • Spain, Madrid
    • Hospital Universitario Puerta de Hierro; Servicio de Oncologia Majadahonda, Madrid, Spain, 28222
  • Spain,
    • Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica Barcelona, , Spain, 08028
    • Hospital Universitari Vall d'Hebron; Oncology Barcelona, , Spain, 08035
    • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia Barcelona, , Spain, 08041
    • Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología La Coruña, , Spain, 15006
    • Hospital Clinico San Carlos; Servicio de Oncologia Madrid, , Spain, 28040
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid, , Spain, 28041
    • Hospital Universitario La Paz; Servicio de Oncologia Madrid, , Spain, 28046
    • HM Sanchinarro - CIOCC; Servicio de Oncologia Madrid, , Spain, 28050
    • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia Malaga, , Spain, 29010
    • Hospital Universitario Virgen del Rocio; Servicio de Oncologia Sevilla, , Spain, 41013
    • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia Valencia, , Spain, 46010
    • Hospital Universitari i Politecnic La Fe; Oncologia Valencia, , Spain, 46026
  • Taiwan,
    • Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, , Taiwan, 807
    • Chang Gung Memorial Foundation - Kaohsiung Kaohsiung, , Taiwan, 00833
    • China Medical University Hospital Taichung, , Taiwan, 40447
    • Taichung Veterans General Hospital Taichung, , Taiwan, 407
    • National Cheng Kung University Hospital Tainan, , Taiwan, 70457
    • National Taiwan University Hospital Taipei, , Taiwan, 10002
    • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology Taipei, , Taiwan, 112
    • Chang Gung Medical Foundation - Linkou; Chest Dept Taoyuan, , Taiwan, 333
  • Thailand,
    • Chulalongkorn Hospital; Medical Oncology Bangkok, , Thailand, 10330
    • Ramathibodi Hospital; Medicine/Oncology Bangkok, , Thailand, 10400
    • Siriraj Hospital; Medical Oncology Unit Bangkok, , Thailand, 10700
    • Maharaj Nakorn Chiang Mai Hospital; Department of Medicine ChiangMai, , Thailand, 50200
  • Turkey,
    • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology Adana, , Turkey, 01250
    • Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic Ankara, , Turkey, 06200
    • Ufuk University Dr. Ridvan Ege Health Research and Implementation Hospital; Oncology Departmant Ankara, , Turkey, 06300
    • Ankara Ataturk Chest Diseases Training and Research Hospital Ankara, , Turkey, 06500
    • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology Istanbul, , Turkey, 34300
    • Ege Uni Medical Faculty Hospital; Oncology Dept Izmir, , Turkey, 35100
    • Izmir Suat Seren Chest Diseases and Surgery Research Hospital Izmir, , Turkey, 35110
    • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department Malatya, , Turkey, 44280
    • Medikal Park Samsun Samsun, , Turkey, 55200
    • Hacettepe Uni Medical Faculty Hospital; Oncology Dept Sihhiye/Ankara, , Turkey, 06230
    • Sureyyapasa Gögüs Hastaliklari ve Gögüs Cerrahisi Egitim ve Arastirma Hastanesi; Gögüs Hastaliklari Yali, , Turkey, 34844
  • Ukraine, KIEV Governorate
    • Medical Center "Adonis" LLC Kapitanovka Village, KIEV Governorate, Ukraine, 08112
  • Ukraine,
    • Chemotherapy SI Dnipropetrovsk MA of MOHU Dnipropetrovsk, , Ukraine, 49102
    • National Cancer Institute MOH of Ukraine Kiev, , Ukraine, 36022
    • Kyiv City Clinical Oncological Center Kyiv, , Ukraine, 03115
    • RCI Sumy Regional Clinical Oncological Dispensary Sumy, , Ukraine, 40005
    • Vinnytsia Regional Clinical Oncology Dispensary; Department of Chemotherapy Vinnytsia, , Ukraine, 21029
    • MI of Zaporizhzhia Regional Council Zaporizhzhia Regional Clinical Oncology Dispensary; Thoracic Zaporizhzhia, , Ukraine, 69040
  • United Kingdom,
    • St Bartholomew's Hospital London, , United Kingdom, EC1A 7BE
    • Guy's Hospital; Guy's Cancer Center London, , United Kingdom, SE1 9RY
    • Wythenshaw Hospital Manchester, , United Kingdom, M23 9QZ
    • Royal Preston Hospital; Lancashire Clinical Research Facility Preston, , United Kingdom, PR2 9HT

Sponsors and Collaborators

Hoffmann-La Roche

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03456076
Other Study ID Numbers: 2017-004331-37
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Hoffmann-La Roche:

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

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Gemcitabine

Cisplatin

Carboplatin

Pemetrexed

Vinorelbine

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on February 25, 2021