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A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung (PROFILE 1014)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154140
First Posted: June 30, 2010
Last Update Posted: November 2, 2017
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.
Information provided by (Responsible Party):
Pfizer
  Purpose
This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

Condition Intervention Phase
Non Squamous Lung Cancer Drug: treatment Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) Based on IRR [ Time Frame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) ]
    PFS was defined as the time from the date of randomization in study until the date of first documented objective tumor progression (according to RECIST v1.1 as determined by IRR) or death (due to any cause), whichever occurred first. PFS (in months) was calculated as (first event date − randomization date +1)/30.44. Objective progression was defined as a 20 percent (%) increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 millimeter (mm) or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From randomization to death or last date known alive for those not known to have died (up to 72 months) ]
    OS (in months) was defined as the duration from start of study treatment to date of death due to any cause. OS = (date of death minus the date of randomization of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.

  • Overall Survival Probability at Month 12 and 18 [ Time Frame: Month 12, 18 ]
    Overall survival probability at Month 12 and 18 was defined as the probability of overall survival at 12 and 18 months respectively, where the OS was defined as the duration from date of randomization to date of death due to any cause. The survival probability was estimated using the Kaplan-Meier method.

  • Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR [ Time Frame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) ]
    ORR was defined as percentage of participants with complete response (CR) or partial response (PR) according to RECIST v1.1 determined by IRR. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as greater than or equal to (>=) 30% decrease taking as reference the baseline sum of lesion dimensions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No clear progression of non-target disease. No new lesions.

  • Duration of Response (DR) Based on IRR [ Time Frame: From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) ]
    DR: time from first documentation of objective tumor response (CR or PR) to first documentation of PD or death due to any cause, whichever occurred first as per RECIST v1.1 determined by IRR. CR: complete disappearance of all target and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions, disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions. c) PD: 20 % increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.

  • Time to Tumor Response (TTR) Based on IRR [ Time Frame: Randomization to first documentation of objective tumor response (up to 35 months) ]
    TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) according to RECIST v1.1 determined by IRR. CR: complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.

  • Percentage of Participants With Disease Control at Week 12 Based on IRR [ Time Frame: Week 12 ]
    Disease control rate at week 12 is defined as the percent of participants with CR, PR, or stable disease (SD) at week 12 according to RECIST v1.1 determined by IRR. The best response of SD would be assigned if SD criteria was met at least once after randomization at a minimum interval of 6 weeks. CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.

  • Time to Progression (TTP) Based on IRR [ Time Frame: Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) ]
    TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date − randomization date +1)/30.44.

  • Time to Intracranial Progression (IC-TTP) Based on IRR [ Time Frame: Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) ]
    IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.

  • Time to Extracranial Progression (EC-TTP) Based on IRR [ Time Frame: Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) ]
    EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.

  • Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to follow up period (up to 72 months) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.

  • Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to follow up period (up to 72 months) ]
    Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.

  • Percentage of Participants With Adverse Events (AEs) According to Maximum Severity [ Time Frame: Baseline up to follow up period (up to 72 months) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.

  • Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182 [ Time Frame: Predose at Day 1 of Cycle 2, 3 and 5 ]
    Ctrough is the concentration prior to study drug administration on Day 1 of Cycle 2 onwards. PF-06260182 is the metabolite of Crizotinib.

  • Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants [ Time Frame: 28 days prior to day 1 of study treatment ]
    The Response Genetics, Inc. Echinoderm Microtubule Associated Protein Like 4 (EML4) ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements [V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7]). Percentage of participants who tested positive for ALK gene fusion variants were reported in this outcome measure.

  • Objective Response Rate (ORR) of Anaplastic Lymphoma Kinase (ALK) Variant Groups Based on IRR [ Time Frame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months) ]
    The Response Genetics, Inc. EML4 ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements [V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7]). Percentage of participants with confirmed CR or PR according to RECIST v1.1 determined by IRR, by type of ALK gene fusion variant were reported in this outcome measure. CR: complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.

  • Time to Deterioration (TTD) in Chest Pain, Dyspnea or Cough [ Time Frame: From randomization of treatment up to deterioration while on study treatment (up to 35 months) ]
    TTD in pain in chest, dyspnea, or cough from the Quality of Life Questionnaire Core 30 (QLQ-LC13) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment (QLQ-LC13) for pain, dyspnea, or cough or at last visit date prior to crossover for participants randomized to chemotherapy who subsequently crossed over to crizotinib. A 10-point or higher change in the score was perceived by participants as clinically significant. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 (European Organization for the Research and Treatment of Cancer) range from 0 to 100, where higher scores indicate greater symptom severity.

  • Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) [ Time Frame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months) ]
    EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).

  • Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) [ Time Frame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months) ]
    EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).

  • Change From Baseline in Lung Cancer Symptom Scores as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) [ Time Frame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months) ]
    QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess the specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of patients with lung cancer receiving chemotherapy. All multi-item scales and single-item measures range from 0 to 100, where higher score indicates greater degree of symptom severity.

  • Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS) [ Time Frame: Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months) ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.

  • Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU) [ Time Frame: Baseline up to follow up period (up to 72 months) ]
    Healthcare resource utilization was to be evaluated using the assessment of the following: date and duration of index admission, duration of hospitalization and date of discharge.

  • Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Hematological Test Abnormalities [ Time Frame: Baseline up to follow up period (up to 72 months) ]
    Anemia(grade[g]1:Less than[<] Lower limit of normal[LLN] to 10gram per[/] deciliter[g/dL],g2:<10 to 8g/dL,g3:<8g/dL,g4:lifethreatening);platelet (g1:<LLN to 75*10^3/millimeter[mm]^3,g2:<75*10^3/mm^3 to 50*10^3/mm^3,g3:<50*10^3/mm^3 to 25*10^3/mm^3,g4:<25*10^3/mm^3);lymphopenia(g1:<LLN to 8*10^2/mm^3,g2:<8*10^2 to 5*10^2/mm^3,g3:<5*10^2 to 2*10^2/mm^3,g4:<2*10^2/mm^3);neutrophil (Absolute)(g1:<LLN to 15*10^2/mm^3,g2:<15*10^2 to 10*10^2/mm^3,g3:<10*10^2 to 5*10^2/mm^3,g4:<5*10^2/mm^3);white blood cell count(g1:<LLN to 3*10^3/mm^3,g2:<3*10^3 to 2*10^3/mm^3,g3:<2*10^3 to 1*10^3/mm^3,g4:<1*10^3/mm^3);hemoglobin(g1:increase in hemoglobin level>0 to 2 g/dL above ULN or above baseline if baseline is above ULN,g2:increase in hemoglobin level>2 to 4g/dL above ULN or above baseline if baseline is above ULN,g3:increase in hemoglobin level>4 g/dL above ULN or above baseline if baseline is above ULN). Only categories with atleast 1 participant with abnormality are reported in this outcome measure.

  • Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Chemistry Test Abnormalities [ Time Frame: Baseline up to follow up period (up to 72 months) ]
    ALT/AST (Grade[g]1:>ULN-3*ULN,g2:>3-5*ULN,g3:>5-20*ULN,g4:>20*ULN);Alkaline Phosphatase (g1:>ULN-2.5*ULN,g2:>2.5-5*ULN,g3:>5-20*ULN,g4:>20*ULN);Creatinine (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-6*ULN,g4:>6*ULN);hyperglycemia (g1:>ULN-160,g2:>160-250,g3:>250-500,g4:>500mg/dL);bilirubin(total) (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-10*ULN,g4:>10*ULN);hypoglycaemia (g1:<LLN-55,g2:<55-40,g3:<40-30,g4:<30mg/dL);hyperkalemia (g1:>ULN-5.5,g2:>5.5-6,g3:>6-7,g4:>7mmol/L);hypokalemia (g1:<LLN-3,g2:<LLN-3,g3:<3-2.5,g4:<2.5mmol/L);hypermagnesemia (g1:>ULN-3,g3:>3-8,g4:>8mg/dL);hypocalcemia (g1:<LLN-8,g2:<8-7,g3:<7-6,g4:<6mg/dL); hypercalcemia (g1:>ULN-11.5,g2:>11.5-12.5,g3:>12.5-13.5,g4:>13.5mg/dL);hypomagnesemia (g1:<LLN-1.2,g2:<1.2-0.9,g3:<0.9-0.7,g4:<0.7mg/dL);hyponatremia (g1:<LLN-130,g3:<130-120,g4:<120mmol/L);hypoalbuminemia (g1:<LLN-3,g2:<3-2,g3:<2,g4:lifethreatening);hypophosphatemia (g1:<LLN-2.5,g2:<2.5-2,g3:<2-1,g4:<1mg/dL). Participant>=1 abnormality given.


Enrollment: 343
Actual Study Start Date: January 13, 2011
Study Completion Date: November 30, 2016
Primary Completion Date: November 30, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: treatment
crizotinib 250mg orally continuous twice daily dosing
Active Comparator: B Drug: treatment
pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigator's choice

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
  • Positive for translocation or inversion events involving the ALK gene locus
  • No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
  • Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.
  • 18 years of age or older with the exception of India which has an upper age limit of 65 years old

Exclusion Criteria:

  • Current treatment on another therapeutic clinical trial.
  • Prior therapy directly targeting ALK.
  • Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.
  • Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
  • Pregnancy or breastfeeding.
  • Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
  • Known HIV infection
  • Known interstitial lung disease or interstitial fibrosis
  • Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study
  Contacts and Locations
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): NCT01154140


  Hide Study Locations
Locations
United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211-1850
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States, 90211-1850
CCTAP
Fontana, California, United States, 92335
Loma Linda University Cancer Center
Loma Linda, California, United States, 92350
Loma Linda University Cancer Center (LLUCC)-Schuman Pavilion
Loma Linda, California, United States, 92354
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
CCTAP
Los Angeles, California, United States, 90027
Kaiser Permanente Southern California
San Diego, California, United States, 92108
CCTAP
San Diego, California, United States, 92120
United States, District of Columbia
Georgetown University Hospital
Washington, D.C., District of Columbia, United States, 20007
Research Pharmacy, Georgetown University Medical Center
Washington, D.C., District of Columbia, United States, 20007
United States, Florida
Lynn Cancer Institute Center for Hematology Oncology
Boca Raton, Florida, United States, 33486
Florida Hospital
Orlando, Florida, United States, 32803
Cancer Institute of Florida
Orlando, Florida, United States, 32804
Investigational Drug Services
Orlando, Florida, United States, 32804
United States, Georgia
Georgia Cancer Specialists
Athens, Georgia, United States, 30606
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
Georgia Cancer Specialists
Decatur, Georgia, United States, 30033
Georgia Cancer Specialists
Macon, Georgia, United States, 31217
Georgia Cancer Specialists
Marietta, Georgia, United States, 30060
Georgia Cancer Specialists
Sandy Springs, Georgia, United States, 30342
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Al Fisher, Pharm D.
Harvey, Illinois, United States, 60426
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Monroe Medical Associates
Harvey, Illinois, United States, 60426
Monroe Medical Associates
Tinley Park, Illinois, United States, 60477
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Lois and Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Monroe Medical Association
Munster, Indiana, United States, 46321
The Community Hospital
Munster, Indiana, United States, 46321
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Center for Cancer Medicine
Biddeford, Maine, United States, 04005
Maine Center for Cancer Medicine
Brunswick, Maine, United States, 04011
Maine Center for Cancer Medicine
Sanford, Maine, United States, 04073
Maine Center for Cancer Medicine
Scarborough, Maine, United States, 04074
United States, Michigan
Kresge Eye Institute
Bingham Farms, Michigan, United States, 48025
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Kresge Eye Institute
Detroit, Michigan, United States, 48201
Karmanos Cancer Institute at Farmington Hills
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States, 63141
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110-1094
Washington University Center for Advanced Medicine Infusion Center Pharmacy
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center
Saint Peters, Missouri, United States, 63376
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
United States, New Jersey
Hematology-Oncology Associates of Northern New Jersey
Morristown, New Jersey, United States, 07962
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
UNM Eye Clinic
Albuquerque, New Mexico, United States, 87106
Memorial Medical Center
Las Cruces, New Mexico, United States, 88011
United States, New York
NSLIJ Health System/Monter Cancer Center
Lake Success, New York, United States, 11042
North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, Oregon
OHSU Knight Cancer Institute
Beaverton, Oregon, United States, 97006
OHSU Knight Cancer Institute
Gresham, Oregon, United States, 97030
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97210
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97216
Oregon Health and Science University
Portland, Oregon, United States, 97239
OHSU Knight Cancer Institute
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Rhode Island
Vincent Armenio
East Providence, Rhode Island, United States, 02914
Pharma Resource
East Providence, Rhode Island, United States, 02915
United States, Tennessee
Tennessee Oncology, PLLC
Dickson, Tennessee, United States, 37055
Tennessee Oncology, PLLC
Franklin, Tennessee, United States, 37067
Tennessee Oncology, PLLC
Gallatin, Tennessee, United States, 37066
Tennessee Oncology, PLLC
Hermitage, Tennessee, United States, 37076
Tennessee Oncology, PLLC
Lebanon, Tennessee, United States, 37087
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, United States, 37130
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37205
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37207
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37211
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States, 37232-5536
Vanderbilt Oncology Pharmacy
Nashville, Tennessee, United States, 37232-7610
Tennessee Oncology, PLLC
Smyrna, Tennessee, United States, 37167
United States, Texas
UT Southwestern Medical Center - Simmons Cancer Center Pharmacy
Dallas, Texas, United States, 75390-9015
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
UT Southwestern University Hospital - William P. Clements, Jr.
Dallas, Texas, United States, 75390
UT Southwestern University Hospital - Zale Lipshy
Dallas, Texas, United States, 75390
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792-5666
Australia, New South Wales
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales, Australia, 2560
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
The Townsville Hospital
Douglas, Queensland, Australia, 4814
The Royal Brisbane & Womens Hospital
Herston, Queensland, Australia, 4006
Parkhaven Medical Center
Hyde Park, Queensland, Australia, 4812
Australia, South Australia
Department of Medical Oncology
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre, Department of Haematology and Medical Oncology
East Melbourne, Victoria, Australia, 3002
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia, 3199
Austria
Klinikum Wels-Grieskirchen
Wels, Austria, 4600
Belgium
UZ Antwerpen-Pneumologie
Edegem, Antwerp, Belgium, 2650
Grand Hopital de Charleroi -Site Notre Dame
Charleroi, Hainaut, Belgium, 6000
Cliniques Universitaires St Luc
Brussels, Belgium, 1200
Universitair Ziekenhuis Brussel / Medische Oncologie
Brussel, Belgium, 1090
Institut Jules Bordet, Centre des Tumeurs de l'ULB
Bruxelles, Belgium, 1000
Universitair Ziekenhuis Gent (U.Z. Gent)
Gent, Belgium, 9000
Centre Hospitalier Universitaire de Liege
Liege, Belgium, 4000
Department of Pulmonary Diseases AZ Delta
Roeselare, Belgium, 8800
Brazil
Instituto Nacional de Cancer - INCA
Rio de Janeiro, RJ, Brazil, 20231 -050
Associacao Hospital de Caridade de Ijui
Ijui, RS, Brazil, 98700-000
Hospital Sao Lucas da PUCRS
Porto Alegre, RS, Brazil, 90610-000
Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP
Sao Paulo, SP, Brazil, 01246-000
Fundacao Pio XII Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil, 14784-400
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B2H 2Y9
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
R.S. McLaughlin Durham Regional Cancer Centre
Oshawa, Ontario, Canada, L1G 2B9
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre
Montreal, Quebec, Canada, H4A 3J1
Institut universitaire de cardiologie et de pneumologie de Quebec (IUCPQ)
Ste-Foy, Quebec, Canada, G1V 4G5
Chile
Instituto Clinico Oncologico del Sur
Temuco, Cautin, Chile, 4810469
Instituto Nacional del Cancer
Santiago, RM, Chile, 8380455
Hospital Clinico Universidad de Chile, Seccion de Oncologia
Independencia, Santiago, Rm, Chile, 8380456
China, Beijing
307 Hospital of PLA
Beijing, Beijing, China, 100071
China, Guangdong
Oncology Center, Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
China, Hubei
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center
Wuhan, Hubei, China, 430023
China, Jiangsu
No.81 Hospital of the PLA
Nanjing, Jiangsu, China, 210002
China, Sichuan
Oncology Department, West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Shanghai Chest Hospital/Department of Pulmonary Medicine
Shanghai, China, 200030
Zhongshan Hospital Fudan University
Shanghai, China, 200030
Shanghai Pulmonary Hospital/Dept. of Oncology
Shanghai, China, 200433
Finland
Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka
Helsinki, Finland, 00290
Satakunnan keskussairaala/Keuhkosairauksien osasto A4
Pori, Finland, 28500
Tampereen yliopistollinen sairaala
Tampere, Finland, 33520
France
Hopital Avicenne
Bobigny Cedex, France, 93009
CHU de Caen
Caen Cedex, France, 14033
CHU Grenoble
Grenoble Cedex, France, 38043
Centre Oscar Lambret
Lille, France, 59020
Centre Leon Berard
Lyon Cedex 08, France, 69373
APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques
Marseille Cedex 20, France, 13915
Hopital Arnaud de Villeneuve / CHU de Montpellier
Montpellier, France, 34295
Hopital Tenon, Service de Pneumologie
Paris cedex 20, France, 75970
Nouvel Hopital Civil - HSU - Pôle de Pathologie Thoracique - Service de Pneumologie
Strasbourg, France, 67091
Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin, Germany, 10117
Thoraxklinik am Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69126
St.Vincentius-Kliniken Karlsruhe
Karlsruhe, Germany, 76137
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Kliniken Maria Hilf GmbH
Moenchengladbach, Germany, 41063
Pius-Hospital Oldenburg
Oldenburg, Germany, 26121
HSK Dr.- Horst-Schmidt-Kliniken GmbH,
Wiesbaden, Germany, 65199
Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Department of Clinical Oncology, Queen Elizabeth Hospital
Kowloon, Hong Kong
India
The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital),
Ahmedabad,, Gujarat, India, 380 016
Tata Memorial Centre, Tata Memorial Hospital,
Mumbai, Maharashtra, India, 400012
Ireland
Aseptic Compounding Unit
Dublin, Ireland, Dublin 8
Department of Medical Oncology
Dublin, Ireland, Dublin 8
Italy
Struttura Operativa Complessa Oncologia Medica A Centro di Riferimento Oncologico
Aviano, Pordenone, Italy, 33081
Farmacia
Aviano (PN), Italy, 33081
Istituto dei tumori Giovanni Paolo II
Bari, Italy, 70124
Unità Operativa di Oncologia Medica Azienda USL Città di Bologna
Bologna, Italy, 40100
Azienda Ospedaliero-Universitaria "Mater Domini"
Catanzaro, Italy, 88100
Unità Operativa di Farmacia - Campus Salvatore venuta
Catanzaro, Italy, 88100
Ospedale Civile Azienda USL Toscana Nord Ovest
Livorno, Italy, 57124
Unità Operativa Farmacia Ospedaliera PO di Livorno
Livorno, Italy, 57124
Fondazione IRCCS Istituto Nazionale Tumori, Struttura Complessa di Medicina Oncologica 1
Milano, Italy, 20133
Farmacia Istituto Europeo di Oncologia IRCCS, U.O. Farmacia
Milano, Italy, 20141
Istituto Europeo di Oncologia
Milano, Italy, 20141
Ospedale Niguarda Ca'Granda, Divisione Oncologia Medica Falck
Milano, Italy, 20162
A.O.R.N. Ospedale Dei Colli - Monaldi
Napoli, Italy, 80131
Farmacia
Napoli, Italy, 80131
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano (TO), Italy, 10043
S.C. Farmacia Ospedaliera , Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano (TO), Italy, 10043
Oncologia Medica, Azienda Ospedaliero- Universitaria di Parma
Parma, Italy, 43126
Farmacia Ospedaliera
Perugia, Italy, 06132
SC Oncologia Medica, Ospedale Santa Maria della Misericordia
Perugia, Italy, 06132
IRCCS -Arcispedale S. Maria Nuova Tecnologie Avanzate e Modelli Assistenziali in Oncologia
Reggio Emilia, Italy, 42123
Istituto Regina Elena, Struttura Complessa Oncologia Medica A
Roma, Italy, 00144
Azienda Ospedaliera San Camillo Forlanini-Padiglione Flaiani
Roma, Italy, 00152
Farmacia Interna
Roma, Italy, 00152
Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria
Roma, Italy, 00168
Japan
Aichi cancer center central hospital
Nagoya, Aichi, Japan, 464-8681
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
Hyogo Cancer Center
Akashi, Hyogo, Japan, 673-8558
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, Japan, 236-0051
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Okayama University Hospital
Okayama-city, Okayama, Japan, 700-8558
Kinki University Hospital
Osakasayama-shi, Osaka, Japan, 589-8511
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan, 411-8777
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan, 104-0045
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
National Hospital Organization Yamaguchi-Ube Medical Center
Ube-shi, Yamaguchi, Japan, 755-0241
National Hospital organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Kyushu University Hospital Respiratory Medicine
Fukuoka, Japan, 812-8582
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center, Sungkyunkwan Univ. School of Medicine
Seoul, Korea, Republic of, 06351
Luxembourg
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg, 1210
Mexico
Instituto Nacional de Cancerologia
Mexico, D.f., Mexico, 14080
Netherlands
Jeroen Bosch Ziekenhuis
's Hertogenbosch, NB, Netherlands, 5223 GZ
VUMC
Amsterdam, Netherlands, 1081 HV
Academisch Ziekenhuis Maastricht / afdeling longziekten en tuberculose
Maastricht, Netherlands, 6229 HX
Norway
Oslo universitetssykehus HF - Radiumhospitalet
Oslo, Norway, 0424
Peru
Clinica Anglo Americana/Centro de Investigacion Oncologia CAA
San Isidro, Lima, Peru, 27
Portugal
Centro Hospitalar e Universitario de Coimbra - Hospital Geral
Coimbra, Portugal, 3041-801
Instituto Português de Oncologia de Lisboa, Prof. Francisco Gentil E.P.E.
Lisboa, Portugal, 1099-023
Centro Hospitalar de Lisboa Norte - Hospital Pulido Valente
Lisboa, Portugal, 1769-001
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, Portugal, 4434-502
Russian Federation
Russian Oncological Research Center N.N. Blokhin
Moscow, Russian Federation, 115478
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 197022
First Saint-Petersburg State Medical University n.a. I.P. Pavlov
Saint-Petersburg, Russian Federation, 197022
First Saint-Petersburg State Medical University n.a. I.P.
Saint-Petersburg, Russian Federation, 197101
Russian Scientific Center of Radiology and Surgical Technologies
Saint-Petersburg, Russian Federation, 197758
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 198255
Samara Regional Clinical Oncology Dispensary
Samara, Russian Federation, 443031
Singapore
National University Hospital
Singapore, Singapore, 119074
National Cancer Centre
Singapore, Singapore, 169610
Parkway Cancer Centre
Singapore, Singapore, 228510
OncoCare Cancer Centre
Singapore, Singapore, 258499
South Africa
University of Witwatersrand Oncology
Johannesburg, Gauteng, South Africa, 2193
Rondebosch Oncology Centre, Rondebosch Medical Centre
Cape Town, South Africa, 7700
Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Hospital Universitario Virgen Macarena
Sevilla, Andalucia, Spain, 41009
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Aragon, Spain, 50009
Hospital Clinic I Provincial de Barcelona
Barcelona, Catalunya, Spain, 08036
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain, 35016
Hospital Ramon Y Cajal
Madrid, Spain, 28034
Hospital Doce de Octubre
Madrid, Spain, 28041
Hospital Universitario Virgen de La Victoria
Malaga, Spain, 29010
Switzerland
Universitaetsspital Basel
Basel, Switzerland, CH-4031
Luzerner Kantonsspital (LUKS)
Luzern, Switzerland, 6000
Kantonsspital Winterthur
Winterthur, Switzerland, CH-8401
Taiwan
Chang Gung Medical Foundation, Kaohsiung Branch
Kaohsiung City, Taiwan, 833
China Medical University Hospital
Taichung, Taiwan, 404
Taichung Veterans General Hospital, Comprehensive Cancer Center
Taichung, Taiwan, 40705
Chang Gung Medical Foundation, LinKou Branch
Taoyuan, Taiwan, 33305
Ukraine
City Multiple-Discipline Clinical Hospital #4,
Dnipropetrovsk, Ukraine, 49102
City Multiple-Discipline Clinical Hospital #4
Dnipropetrovsk, Ukraine, 49102
Department of Oncology and Medical Radiology, SI "DMA of MOH, Ukraine
Dnipropetrovsk, Ukraine, 49102
Kyiv City Clinical Oncologic Center/Department of Chemotherapy
Kyiv, Ukraine, 03115
Lviv State Oncologic Regional Treatment and Diagnostic Center
Lviv, Ukraine, 79031
United Kingdom
Addenbrooke's Hospital, Oncology Centre
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Lister Hospital
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Queen Elizabeth II Hospital
Welwyn Garden City, Hertfordshire, United Kingdom, AL7 4HQ
Spire Manchester Hospital
Manchester, Lancashire, United Kingdom, M16 8AJ
Mount Vernon Hospital, Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom, HA6 2RN
NHS Greater Glasgow and Clyde Health Board, Beatson West of Scotland Cancer Centre,
Glasgow, Scotland, United Kingdom, G12 0YN
Ross Hall Hospital
Glasgow, Scotland, United Kingdom, G52 3NQ
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
The Christie Hospital NHS Foundation Trust, Department of Medical Oncology
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01154140     History of Changes
Other Study ID Numbers: A8081014
2010-021336-33 ( EudraCT Number )
XALCORI ( Other Identifier: Alias Study Number )
First Submitted: June 29, 2010
First Posted: June 30, 2010
Results First Submitted: November 26, 2014
Results First Posted: January 5, 2015
Last Update Posted: November 2, 2017
Last Verified: September 2017

Keywords provided by Pfizer:
open label
randomized Phase 3
first line treatment
non squamous lung cancer
ALK translocation event positive

Additional relevant MeSH terms:
Cisplatin
Carboplatin
Pemetrexed
Crizotinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors