A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants (ALEX)
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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 : March 21, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer | Drug: Alectinib Drug: Crizotinib | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Alectinib
Participants will receive alectinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
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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.
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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. |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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) ]
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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

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

United States, Arizona | |
Mayo Clinic Arizona | |
Phoenix, Arizona, United States, 85259 | |
United States, California | |
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 | |
Banner MD Anderson Cancer Center | |
Greeley, Colorado, United States, 85234 | |
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, 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, 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, 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 | |
Hospital das Clinicas - UFRGS | |
Porto Alegre, RS, Brazil, 90035-903 | |
Centro de Pesquisas Oncologicas - CEPON | |
Florianopolis, SC, Brazil, 88034-000 | |
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, 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 | |
China | |
Sun Yet-sen University Cancer Center | |
Guangzhou, China, 510060 | |
Shanghai Pulmonary Hospital | |
Shanghai, China, 200433 | |
Costa Rica | |
Clinica CIMCA | |
San José, Costa Rica, 10103 | |
Egypt | |
Kasr Eieny Uni Hospital; Oncology (Nemrock) | |
Cairo, Egypt, 11555 | |
France | |
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie | |
Grenoble, France, 38043 | |
CHRU de Lille | |
Lille, France, 59037 | |
Centre Leon Berard; Departement Oncologie Medicale | |
Lyon, France, 69373 | |
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 | |
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 | |
Rambam Medical Center; Oncology | |
Haifa, Israel, 3109601 | |
Meir Medical Center; Oncology | |
Kfar-Saba, Israel, 4428164 | |
Italy | |
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 | |
Sant'Andrea Delle Fratte (PG), Umbria, Italy, 06132 | |
Korea, Republic of | |
National Cancer Center | |
Goyang-si, Korea, Republic of, 10408 | |
Seoul National University Bundang Hospital | |
Seongnam-si, Korea, Republic of, 13605 | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 03080 | |
Severance Hospital, Yonsei University Health System | |
Seoul, Korea, Republic of, 03722 | |
Asan Medical Center | |
Seoul, Korea, Republic of, 05505 | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 06351 | |
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 | |
Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii | |
Olsztyn, Poland, 10-357 | |
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii | |
Otwock, Poland, 05-400 | |
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology | |
Warszawa, Poland, 02-781 | |
Portugal | |
CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo | |
Coimbra, Portugal, 3000-075 | |
IPO de Lisboa; Servico de Pneumologia | |
Lisboa, Portugal, 1099-023 | |
IPO do Porto; Servico de Oncologia Medica | |
Porto, Portugal, 4200-072 | |
Russian Federation | |
Moscow City Oncology Hospital #62 | |
Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423 | |
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept | |
Moscow, Russian Federation, 105229 | |
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 | |
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 Universitario Puerta de Hierro; Servicio de Oncologia | |
Majadahonda, Madrid, Spain, 28222 | |
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 Universitario Virgen del Rocio; Servicio de Oncologia | |
Sevilla, Spain, 41013 | |
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 | |
National Cheng Kung Univ Hosp | |
Tainan, Taiwan, 00704 | |
Taipei Veterans General Hospital | |
Taipei City, Taiwan, 112 | |
National Taiwan University Hospital | |
Taipei, Taiwan, 10002 | |
Taichung Veterans General Hospital | |
Xitun Dist., Taiwan, 40705 | |
Thailand | |
National Cancer Inst. | |
Bangkok, Thailand, 10400 | |
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, 01230 | |
Ankara University Medical Faculty; Medikal Onkoloji | |
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 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Documents provided by Hoffmann-La Roche:
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT02075840 |
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: | March 21, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |