Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants (ALEX)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02075840
Recruitment Status : Active, not recruiting
First Posted : March 3, 2014
Results First Posted : March 15, 2018
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, consent withdrawal or death. The study is expected to last approximately 42 months.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Alectinib Drug: Crizotinib Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : August 19, 2014
Actual Primary Completion Date : February 9, 2017
Estimated Study Completion Date : September 29, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alectinib
Participants will receive alectinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Drug: Alectinib
Participants will receive alectinib 600 mg orally (four 150 mg capsules) BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Other Name: RO5424802

Active Comparator: Crizotinib
Participants will receive crizotinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Drug: Crizotinib
Participants will receive crizotinib 250 mg capsules orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) by Investigator Assessment [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    PFS was assessed as time to disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.

  2. Percentage of Participants With PFS Event by Investigator Assessment [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    PFS was assessed percentage of participants with disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.


Secondary Outcome Measures :
  1. PFS Independent Review Committee (IRC)-Assessed [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.

  2. Percentage of Participants With PFS Event by IRC [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    PFS was assessed as percentage of participants with disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.

  3. Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria [ Time Frame: Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months) ]
    CNS progression was assessed as percentage of participants with an event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.

  4. Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria [ Time Frame: Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months) ]
    CNS progression was assessed as percentage of participants with event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.

  5. Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

  6. Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators [ Time Frame: First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.

  7. Overall Survival (OS) [ Time Frame: From randomization until death (up to 43 months) ]
    Overall survival (OS) was defined as the time from randomization to death from any cause.

  8. Percentage of Participants With OS Event [ Time Frame: From randomization until death (up to 43 months) ]
    Overall survival (OS) was defined as the time from randomization to death from any cause.

  9. Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria [ Time Frame: Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    CNS ORR was defined as the percentage of participants who attained CR or PR and had measurable/non-measurable CNS lesions at baseline. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

  10. CNS DOR IRC-assessed According to RECIST v1.1 Criteria [ Time Frame: First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months) ]
    CNS DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.

  11. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to 28 months in the crizotinib arm and up to 30 months in the alectinib arm ]
    An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  12. Area Under The Concentration-Time Curve (AUC) of Alectinib [ Time Frame: Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months) ]
  13. Maximum Concentration (Cmax) of Alectinib [ Time Frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) ]
  14. Time to Reach Cmax (Tmax) of Alectinib [ Time Frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) ]
  15. AUC of Alectinib Metabolite [ Time Frame: Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months) ]
  16. Cmax of Alectinib Metabolite [ Time Frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) ]
  17. Tmax of Alectinib Metabolite [ Time Frame: Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months) ]
  18. Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30) [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.

  19. Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30) [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.

  20. Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13) [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.

  21. Percentage of Participants With Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13) [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.

  22. Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.

  23. HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.

  24. HRQoL by EORTC Quality of Life Questionnaire LC13 Score Dyspnoea [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.

  25. HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Chest [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.

  26. HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Arm and Shoulder [ Time Frame: Baseline, every 4 weeks until disease progression (up to 33 months) ]
    The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test
  • Life expectancy of at least 12 weeks
  • Eastern cooperative oncology group performance status (ECOG PS) of 0-2
  • Participants with no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC
  • Adequate renal, and hematologic function
  • Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
  • Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1) prior to the administration of study treatment
  • Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline)
  • Negative pregnancy test for all females of child bearing potential
  • Use of highly effective contraception as defined by the study protocol

Exclusion Criteria:

  • Participants with a previous malignancy within the past 3 years
  • Any gastrointestinal (GI) disorder or liver disease
  • National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia)
  • History of organ transplant
  • Co-administration of anti-cancer therapies other than those administered in this study
  • Participants with baseline QTc greater than (>) 470 milliseconds or symptomatic bradycardia
  • Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose until the end of study treatment
  • Recipient of any drug with potential QT interval prolonging effects within 14 days prior to the first dose for all participants and while on treatment through the end of the study for crizotinib-treated participants only
  • History of hypersensitivity to any of the additives in the alectinib and crizotinib drug formulation
  • Pregnancy or lactation
  • Any clinically significant disease or condition (or history of) 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, in the opinion of the principal investigator, pose an unacceptable risk to the participant in this study
  • 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 participant 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): NCT02075840


  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85259
United States, California
St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
Fullerton, California, United States, 92835
Moores UCSD Cancer Center; Dept Clinical Trials Office
La Jolla, California, United States, 92093-0698
Long Beach Memorial Medical Center; Oncology
Long Beach, California, United States, 90806
North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr
Northridge, California, United States, 91328
Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
Orange, California, United States, 92868
TMPN/ Cancer Care Associates
Redondo Beach, California, United States, 90277
UCSF Helen Diller Family CCC
San Francisco, California, United States, 94158
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, United States, 81501
United States, Florida
University of Miami-Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Cancer Institute of Florida PA
Orlando, Florida, United States, 32804
Memorial Health Care System
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30308
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Marietta, Georgia, United States, 30060
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Med Ctr; Hem/Onc
Boston, Massachusetts, United States, 02215
Dana Farber Can Ins
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
Washington Uni School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Center - Peak
Las Vegas, Nevada, United States, 89128
United States, New York
Columbia University Medical Center
Bronx, New York, United States, 10463
United States, Pennsylvania
St. Lukes Hospital and Health Network
Bethlehem, Pennsylvania, United States, 18015
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
University of Pittsburgh Medical Center; Division of Hematology-Oncology
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-8813
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Australia, New South Wales
Kinghorn Cancer Centre; St Vincents Hospital
Darlinghurst, New South Wales, Australia, 2010
Royal North Shore Hospital; Oncology
St. Leonards, New South Wales, Australia, 2065
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Australia, South Australia
Queen Elizabeth Hospital; Medical Oncology
Woodville South, South Australia, Australia, 5011
Australia
Monash Health Translational Precinct; Clinical Trials Centre, Level 3
Victoria, Australia, 3168
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska; Clinic for Pulmonary Diseases
Banja Luka, Bosnia and Herzegovina, 78000
University Clinical Center Sarajevo;Clinic for Pulmonary disease
Sarajevo, Bosnia and Herzegovina, 71000
University Clinical Center Sarajevo;Institute of oncology
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Centro de Pesquisa Clínica- Instituto do Câncer do Ceará- ICC
Fortaleza, CE, Brazil, 60125-120
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil, 90035-903
Centro de Pesquisas Oncologicas - CEPON
Florianopolis, SC, Brazil, 88034-000
Clinica de Neoplasias Litoral
Itajai, SC, Brazil, 88301-220
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP, Brazil, 01246-000
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital; Oncology
Toronto, Ontario, Canada, M5G 1X5
Canada, Saskatchewan
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Saskatoon, Saskatchewan, Canada, S7N 4H4
Chile
Centro Internacional de Estudios Clínicos (CIEC)
Santiago, Chile, 8420383
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco, Chile, 4810469
China
Sun Yet-sen University Cancer Center
Guangzhou, China, 510060
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Costa Rica
Clinica CIMCA
San Jose, Costa Rica, 10103
Egypt
Kasr Eieny Uni Hospital; Oncology (Nemrock)
Cairo, Egypt, 11555
Nci; Oncology Dept
Cairo, Egypt, 11796
France
Centre Georges Francois Leclerc
Dijon, France, 21000
CHU de Grenoble
Grenoble, France, 38043
CHRU de Lille
Lille, France, 59037
Centre Leon Berard; Departement Oncologie Medicale
Lyon, France, 69373
Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique
Marseille, France, 13915
Hopital Tenon;Pneumologie
Paris, France, 75970
Hopital Haut Leveque
Pessac, France, 33604
Hopital Pontchaillou
Rennes, France, 35033
Germany
St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie
Karlsruhe, Germany, 76137
Klinik Löwenstein gGmbH Medizinische Klinik II
Löwenstein, Germany, 74245
Greece
Uoa Sotiria Hospital; Oncology
Athens, Greece, 115 27
Univ General Hosp Heraklion; Medical Oncology
Heraklion, Greece, 711 10
Guatemala
Grupo Angeles
Guatemala City, Guatemala, 01015
Hong Kong
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
Hong Kong, Hong Kong
Princess Margaret Hospital; Oncology
Hong Kong, Hong Kong
Queen Mary Hospital; Medicine & Respiratory
Hong Kong, Hong Kong
Tuen Mun Hospital; Clinical Oncology
Hong Kong, Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin, Hong Kong
Israel
Soroka Medical Center; Oncology Dept
Beer Sheva, Israel, 8410100
Rambam Medical Center; Oncology
Haifa, Israel, 3109601
Shaare Zedek Medical Center; Oncology Dept
Jerusalem, Israel, 91031
Meir Medical Center; Oncology
Kfar-Saba, Israel, 4428164
Belinson Medical Center, Division of Oncology
Petach Tikva, Israel, 4941492
Assaf Harofeh; Oncology
Zerifin, Israel, 6093000
Italy
Azienda Ospedaliera S.G. Moscati; Division of Medical Oncology
Avellino, Campania, Italy, 83100
Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
Napoli, Campania, Italy, 80131
A.O. Universitaria Di Parma; Oncologia Medica
Parma, Emilia-Romagna, Italy, 43100
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
Ravenna, Emilia-Romagna, Italy, 48100
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
Roma, Lazio, Italy, 00161
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano, Lombardia, Italy, 20133
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milano, Lombardia, Italy, 20141
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano, Piemonte, Italy, 10043
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Puglia, Italy, 70124
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
Catania, Sicilia, Italy, 95122
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Perugia, Umbria, Italy, 06156
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
Padova, Veneto, Italy, 35128
Korea, Republic of
National Cancer Center
Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 13620
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center - Oncology
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 6351
Mexico
Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación
Mexico City, Mexico, 14080
New Zealand
Uni of Auckland; Medical School
Auckland, New Zealand
Poland
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdańsk, Poland, 80-214
Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej
Lublin, Poland, 20-064
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc
Olsztyn, Poland, 10-357
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
Otwock, Poland, 05-400
Med.-Polonia Sp. z o.o. NSZOZ
Poznan, Poland, 60-693
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology
Warszawa, Poland, 02-781
Portugal
Hospital Geral; Servico de Pneumologia
Coimbra, Portugal, 3041-801
IPO de Lisboa; Servico de Pneumologia
Lisboa, Portugal, 1099-023
IPO do Porto; Servico de Oncologia Medica
Porto, Portugal, 4200-072
Russian Federation
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow, Russian Federation, 105229
Moscow city oncology hospital #62 of Moscow Healthcare Department
Moscow, Russian Federation, 143423
City Clinical Hospital No. 1
Novosibirsk, Russian Federation, 630047
Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis
Obninsk, Russian Federation, 249036
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
Serbia
Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinical Center Bezanijska Kosa; Oncology
Belgrade, Serbia, 11080
Institute for pulmonary diseases of Vojvodina
Sremska Kamenica, Serbia, 21204
Singapore
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore, Singapore, 119228
National Cancer Centre; Medical Oncology
Singapore, Singapore, 169610
Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, Spain, 08916
Hospital General Univ. de Alicante; Servicio de Oncologia
Alicante, Spain, 3010
Hospital Universitario Quiron Dexeus
Barcelona, Spain, 08028
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona, Spain, 08036
Hospital Universitario de la Princesa; Servicio de Oncologia
Madrid, Spain, 28006
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Madrid, Spain, 28222
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla, Spain, 41013
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
Zaragoza, Spain, 50009
Switzerland
Universitaetsspital Basel; Onkologie
Basel, Switzerland, 4031
Inselspital Bern; Universitätsklinik für medizinische Onkologie
Bern, Switzerland, 3010
CHUV; Departement d'Oncologie
Lausanne, Switzerland, 1011
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zürich, Switzerland, 8091
Taiwan
China Medical University Hospital
Taichung, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taiwan, 407
National Cheng Kung Univ Hosp
Tainan, Taiwan, 00704
Taipei Veterans General Hospital
Taipei City, Taiwan, 112
National Taiwan University Hospital
Taipei, Taiwan, 10002
Chang Gung Memorial Hospital - Linkou
Taoyuan, Taiwan, 333
Thailand
National Cancer Inst.
Bangkok, Thailand, 10400
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, Thailand, 10700
Chiang Rai Prachanukroh Hospital; Department Of Medicine
Chiang Rai, Thailand, 57000
Khonkaen Hospital
Khonkaen, Thailand, 40000
King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University
Patumwan, Thailand, 10330
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
Songkhla, Thailand, 90110
Turkey
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, Turkey, 01250
Ankara University Medical Faculty; Medikal Onkoloji
Ankara, Turkey, 06100
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Ankara, Turkey, 06100
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, Turkey, 22770
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, Turkey, 44280
Ukraine
Dnipropetrovsk State Medical Academy; Chemotherapy Department
Dnipropetrovsk, Ukraine, 49102
Karkiv Regional Oncology Center
Kharkiv, Ukraine, 61070
Kyiv Regional Oncological Dispensary
Kyiv, Ukraine, 04107
Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy
Lviv, Ukraine, 79031
United Kingdom
Birmingham Heartlands Hospital; Dept of Oncology
Birmingham, United Kingdom, B9 5SS
University College London Hospital
London, United Kingdom, NW1 - 2PG
Guys & St Thomas Hospital; Department of Oncology
London, United Kingdom, SE1 9RT
Royal Preston Hosp; Rosemere Cancer Ctr
Preston, United Kingdom, PR2 9HT
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
Statistical Analysis Plan  [PDF] February 6, 2018
Study Protocol  [PDF] February 6, 2018


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02075840     History of Changes
Other Study ID Numbers: BO28984
2013-004133-33 ( EudraCT Number )
First Posted: March 3, 2014    Key Record Dates
Results First Posted: March 15, 2018
Last Update Posted: October 10, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Crizotinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action