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NCT03456076

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

257

Start Date

2018-08-16

Completion Date

2026-11-19

Last Updated

2026-01-30

Healthy Volunteers

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Alectnib

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

DRUG

Cisplatin

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

DRUG

Vinorelbine

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

DRUG

Gemcitabine

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

DRUG

Pemetrexed

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

DRUG

Carboplatin

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

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

Locations (114)

Rush University Medical Center

Chicago, Illinois, United States

MGH Cancer Center

Boston, Massachusetts, United States

AHN Cancer Institute ? Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

GenesisCare North Shore

St Leonards, New South Wales, Australia

Peter MacCallum Cancer Center

Melbourne, Victoria, Australia

Krankenhaus Nord - Klinik Floridsdorf

Vienna, Austria

Healthcare Institution Grodno University Hospital

Hrodna, Grodnenskaya, Belarus

Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary?

Homyel, Homyel'skaya Voblasts', Belarus

Vitebsk Regional Clinical Oncology Dispensary

Vitebsk, Vitebsk Oblast, Belarus

Clinical center University of Sarajevo

Sarajevo, Bosnia and Herzegovina

Beijing Cancer Hospital

Beijing, China

Jilin Cancer Hospital

Changchun, China

West China Hospital, Sichuan University

Chengdu, China

Fujian Medical University Union Hospital

Fujian, China

Guangdong General Hospital

Guangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Shandong Cancer Hospital

Jinan, China

Shanghai Chest Hospital

Shanghai, China

Zhongshan Hospital Fudan University

Shanghai, China

Shenzhen People's Hospital

Shenzhen, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

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

Xi'an, China

Odense Universitetshospital, Onkologisk Afdeling R

Odense C, Denmark

Kasr Eieny Uni Hospital

Cairo, Egypt

CHU Angers

Angers, France

Hopital Nord AP-HM

Marseille, France

Hopital Bichat Claude Bernard

Paris, France

Institut Gustave Roussy

Villejuif, France

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

Georgsmarienhütte, Germany

Thoraxklinik Heidelberg gGmbH

Heidelberg, Germany

Fachklinik für Lungenerkrankungen

Immenhausen, Germany

Metropolitan Hospital

Athens, Greece

Theageneio Hospital

Thessaloniki, Greece

Orszagos Onkologiai Intezet

Budapest, Hungary

Hetenyi Geza County Hospital

Szolnok, Hungary

Rambam Health Care Campus

Haifa, Israel

Meir Medical Center

Kfar Saba, Israel

Az. Osp. Monaldi

Naples, Campania, Italy

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

Rome, Lazio, Italy

Irccs Istituto Europeo di Oncologia (IEO)

Milan, Lombardy, Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Piedmont, Italy

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

Perugia, Umbria, Italy

Aichi Cancer Center

Aichi, Japan

National Cancer Center Hospital East

Chiba, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Hiroshima University Hospital

Hiroshima, Japan

National Hospital Organization Hokkaido Cancer Center

Hokkaido, Japan

National Hospital Organization Himeji Medical Center

Hyōgo, Japan

Kanagawa Cancer Center

Kanagawa, Japan

Kumamoto University Hospital

Kumamoto, Japan

Kyoto University Hospital

Kyoto, Japan

Sendai Kousei Hospital

Miyagi, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Okayama University Hospital

Okayama, Japan

Osaka City General Hospital

Osaka, Japan

Shizuoka Cancer Center

Shizuoka, Japan

National Cancer Center Hospital

Tokyo, Japan

Juntendo University Hospital

Tokyo, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Tokyo Medical University Hospital

Tokyo, Japan

Almaty Oncology Center

Almaty, Kazakhstan

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

Skopje, North Macedonia

Private Health Organization Acibadem Sistina Hospital

Skopje, North Macedonia

Gdanski Uniwersytet Medyczny

Gda?sk, Poland

Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II

Krakow, Poland

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

Olsztyn, Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, Poland

Prof Dr I Chiricuta Institute of Oncology

Cluj-Napoca, Romania

Oncomed SRL

Timișoara, Romania

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, Russia

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

Moscow, Moscow Oblast, Russia

P.A. Gertsen Cancer Research Inst.

Moscow, Moscow Oblast, Russia

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, Sankt-Peterburg, Russia

SPb City Clin Onc Dsp

Saint Petersburg, Sankt-Peterburg, Russia

Scientific Research Oncology Institute named after N.N. Petrov

Saint Petersburg, Sankt-Peterburg, Russia

GUZ Regional clinical hospital # 1

Krasnodar, Russia

National Cancer Center

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Ajou University Medical Center

Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Germans Trias i Pujol

Barcelona, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Chang Gung Memorial Foundation - Kaohsiung

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Chang Gung Medical Foundation - Linkou

Taoyuan District, Taiwan

Taichung Veterans General Hospital

Xitun Dist., Taiwan

Ramathibodi Hospital

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital

Adana, Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital

Ankara, Turkey (Türkiye)

Ankara Ataturk Chest Diseases Training and Research Hospital

Ankara, Turkey (Türkiye)

Istanbul Uni Cerrahpasa Medical Faculty Hospital

Istanbul, Turkey (Türkiye)

Ege Uni Medical Faculty Hospital

Izmir, Turkey (Türkiye)

Izmir Suat Seren Chest Diseases and Surgery Research Hospital

Izmir, Turkey (Türkiye)

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

Malatya, Turkey (Türkiye)

Medikal Park Samsun

Samsun, Turkey (Türkiye)

Medical center of Yuriy Spizhenko LLC

Kapitanovka Village, KIEV Governorate, Ukraine

Chemotherapy SI Dnipropetrovsk MA of MOHU

Dnipropetrovsk, Ukraine

Kyiv City Clinical Oncological Center

Kyiv, Ukraine

RCI Sumy Regional Clinical Oncological Dispensary

Sumy, Ukraine

Vinnytsia Regional Clinical Oncology Dispensary

Vinnytsia, Ukraine

Guys Hospital

London, United Kingdom

Wythenshaw Hospital

Manchester, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (114)