A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT03456076
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 257
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alectinib Alectnib - Platinum-Based Chemotherapy Cisplatin - Platinum-Based Chemotherapy Gemcitabine - Platinum-Based Chemotherapy Carboplatin - Platinum-Based Chemotherapy Vinorelbine - Platinum-Based Chemotherapy Pemetrexed -
- Primary Outcome Measures
Name Time Method Disease-free Survival (DFS), as Assessed by the Investigator Approximately 58 months 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
Name Time Method AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Overall Survival (OS) 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.Percentage of Participants With Adverse Events (AEs) Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles) An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Plasma Concentration of Alectinib Predose (2 hours) Week 3 - Week 96 Plasma Concentration of Alectinib Metabolite M4 Predose (2 hours) Week 3 - Week 96
Trial Locations
- Locations (143)
Pavlov First Saint Petersburg State Medical University
🇷🇺St. Petersburg, Sankt Petersburg, Russian Federation
Scientific Research Oncology Institute named after N.N. Petrov; Oncology
🇷🇺St. Petersburg, Sankt Petersburg, Russian Federation
GUZ Regional clinical hospital # 1
🇷🇺Krasnodar, Russian Federation
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
🇵🇱Warszawa, Poland
Cardiomed Medical Center
🇷🇴Cluj-Napoca, Romania
Oncomed SRL; Oncologie
🇷🇴Timisoara, Romania
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol.
🇵🇱Kraków, Poland
P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept
🇷🇺Moscow, Moskovskaja Oblast, Russian Federation
SPb City Clin Onc Dsp; Chemotherapy
🇷🇺Sankt-peterburg, Sankt Petersburg, Russian Federation
China Medical University Hospital
🇨🇳Taichung, Taiwan
Chulalongkorn Hospital; Medical Oncology
🇹🇭Bangkok, Thailand
Medical center of Yuriy Spizhenko LLC
🇺🇦Kapitanovka Village, KIEV Governorate, Ukraine
Taichung Veterans General Hospital
🇨🇳Xitun Dist., Taiwan
Ramathibodi Hospital; Medicine/Oncology
🇹🇭Bangkok, Thailand
Chemotherapy SI Dnipropetrovsk MA of MOHU
🇺🇦Dnipropetrovsk, Ukraine
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Metropolitan Hospital
🇬🇷Athens, Greece
Theageneio Hospital
🇬🇷Thessaloniki, Greece
Hopital Bichat Claude Bernard; Oncologie Serv.
🇫🇷Paris, France
Orszagos Onkologiai Intezet
🇭🇺Budapest, Hungary
Fachklinik für Lungenerkrankungen
🇩🇪Immenhausen, Germany
Ch De Saint Quentin; Medecine B14
🇫🇷St Quentin, France
Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary?
🇧🇾Gomel, Homyel'skaya Voblasts', Belarus
Beijing Cancer Hospital
🇨🇳Beijing, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan City, China
Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
🇦🇹Wien, Austria
Northern Cancer Institute
🇦🇺St Leonards, New South Wales, Australia
Vitebsk Regional Clinical Oncology Dispensary
🇧🇾Vitebsk, Vitsyebskaya Voblasts', Belarus
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Fujian Medical University Union Hospital
🇨🇳Fujian, China
Guangdong General Hospital
🇨🇳Guangzhou, China
Jilin Cancer Hospital
🇨🇳Changchun, China
Clinical center University of Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
Hetenyi Geza County Hospital; Onkologiai Kozpont
🇭🇺Szolnok, Hungary
Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1
🇮🇹Roma, Lazio, Italy
Shanghai Chest Hospital
🇨🇳Shanghai, China
CHU Angers
🇫🇷Angers, France
Ajou University Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
Tokyo Medical University Hospital
🇯🇵Tokyo, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
Hopital Nord AP-HM
🇫🇷Marseille, France
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
🇹🇷Sihhiye/Ankara, Turkey
Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie
🇫🇷Toulon, France
Kasr Eieny Uni Hospital; Oncology (Nemrock)
🇪🇬Cairo, Egypt
Thoraxklinik Heidelberg gGmbH
🇩🇪Heidelberg, Germany
Rambam Health Care Campus; Oncology
🇮🇱Haifa, Israel
National Cancer Institute
🇪🇬Cairo, Egypt
Semmelweis Egyetem, AOK, Pulmonologiai Klinika
🇭🇺Budapest, Hungary
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
🇩🇪Georgsmarienhütte, Germany
Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, France
Irccs Ospedale San Raffaele;Oncologia Medica
🇮🇹Milano, Lombardia, Italy
Meir Medical Center
🇮🇱Kfar- Saba, Israel
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
University of Pecs; 1St Department of Medicine
🇭🇺Pecs, Hungary
Almaty Oncology Center
🇰🇿Almaty, Kazakhstan
Azienda Osp. Univ di Modena; Dept Onc & Hem
🇮🇹Modena, Emilia-Romagna, Italy
National Cancer Center Hospital East
🇯🇵Chiba, Japan
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
🇮🇹Ravenna, Emilia-Romagna, Italy
National Hospital Organization Himeji Medical Center
🇯🇵Hyogo, Japan
Kanagawa Cancer Center
🇯🇵Kanagawa, Japan
Az. Osp. Monaldi; 1 Pneumologia Oncologica
🇮🇹Napoli, Campania, Italy
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
🇪🇸Valencia, Spain
Ege Uni Medical Faculty Hospital; Oncology Dept
🇹🇷Izmir, Turkey
Izmir Suat Seren Chest Diseases and Surgery Research Hospital
🇹🇷Izmir, Turkey
Aichi Cancer Center
🇯🇵Aichi, Japan
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
🇪🇸Malaga, Spain
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Sendai Kousei Hospital
🇯🇵Miyagi, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia
🇮🇹Cremona, Lombardia, Italy
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Prof Dr I Chiricuta Institute of Oncology; Oncology Department
🇷🇴Cluj-napoca, Romania
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
🇪🇸La Coruña, Spain
Osaka City General Hospital
🇯🇵Osaka, Japan
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
🇪🇸Badalona, Barcelona, Spain
Gdanski Uniwersytet Medyczny; Katedra i Klinika Onkologii i Radioterapii
🇵🇱Gda?sk, Poland
Dolnoslaskie Centrum Chorob Pluc we Wroclawiu
🇵🇱Wroc?aw, Poland
Moscow City Oncology Hospital #62
🇷🇺Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation
Chang Gung Medical Foundation - Linkou; Chest Dept
🇨🇳Taoyuan, Taiwan
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
🇪🇸Barcelona, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
🇪🇸Sevilla, Spain
Hospital Universitario Donostia: Oncology Service
🇪🇸Donostia-san Sebastian, Guipuzcoa, Spain
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitari i Politecnic La Fe; Oncologia
🇪🇸Valencia, Spain
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Private Health Organization Acibadem Sistina Hospital
🇲🇰Skopje, North Macedonia
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
🇹🇷Adana, Turkey
Medikal Park Samsun
🇹🇷Samsun, Turkey
Hospital Universitario La Paz; Servicio de Oncologia
🇪🇸Madrid, Spain
Siriraj Hospital; Medical Oncology Unit
🇹🇭Bangkok, Thailand
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
🇹🇷Malatya, Turkey
Hospital Clinico San Carlos; Servicio de Oncologia
🇪🇸Madrid, Spain
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Hospital Universitario 12 de Octubre; Servicio de Oncologia
🇪🇸Madrid, Spain
RCI Sumy Regional Clinical Oncological Dispensary
🇺🇦Sumy, Ukraine
Vinnytsia Regional Clinical Oncology Dispensary; Department of Chemotherapy
🇺🇦Vinnytsia, Ukraine
Shandong Cancer Hospital
🇨🇳Jinan, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, China
Shenzhen People's Hospital
🇨🇳Shenzhen, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
🇨🇳Xi'an, China
Zhejiang Cancer Hospital
🇨🇳Zhejiang, China
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
🇮🇹Perugia, Umbria, Italy
Odense Universitetshospital, Onkologisk Afdeling R
🇩🇰Odense C, Denmark
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
🇮🇹Orbassano, Piemonte, Italy
National Hospital Organization Hokkaido Cancer Center
🇯🇵Hokkaido, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Tokyo, Japan
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Korea, Republic of
MGH Cancer Center
🇺🇸Boston, Massachusetts, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Healthcare Institution Grodno University Hospital; Regional Oncologic Dispensary
🇧🇾Grodno, Hrodzyenskaya Voblasts', Belarus
Institut Gustave Roussy; Pathologie Thoracique
🇫🇷Villejuif cedex, France
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
🇮🇹Aviano, Friuli-Venezia Giulia, Italy
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
🇮🇹Milano, Lombardia, Italy
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
🇮🇹Pisa, Toscana, Italy
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
🇪🇸Barcelona, Spain
Juntendo University Hospital
🇯🇵Tokyo, Japan
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax
🇲🇰Skopje, North Macedonia
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
🇵🇱Poznan, Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
🇵🇱Olsztyn, Poland
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
🇷🇺Moscow, Moskovskaja Oblast, Russian Federation
Hospital Universitari Vall d'Hebron; Oncology
🇪🇸Barcelona, Spain
Chang Gung Memorial Foundation - Kaohsiung
🇨🇳Kaohsiung, Taiwan
Ankara Ataturk Chest Diseases Training and Research Hospital
🇹🇷Ankara, Turkey
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
🇹🇷Istanbul, Turkey
Kyiv City Clinical Oncological Center
🇺🇦Kyiv, Ukraine
Guys Hospital; Guys Cancer Center
🇬🇧London, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom
Wythenshaw Hospital
🇬🇧Manchester, United Kingdom
GenesisCare North Shore
🇦🇺St Leonards, New South Wales, Australia
Krankenhaus Nord - Klinik Floridsdorf
🇦🇹Wien, Austria
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Peter MacCallum Cancer Center
🇦🇺Melbourne, Victoria, Australia
Healthcare Institution Grodno University Hospital
🇧🇾Grodno, Hrodzyenskaya Voblasts', Belarus
AHN Cancer Institute ? Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States