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)

• ClinicalTrials.gov Identifier: NCT01154140
• Recruitment Status: Completed
• First Posted: June 30, 2010
• Results First Posted: January 5, 2015
• Last Update Posted: November 6, 2017
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

Condition or disease	Intervention/treatment	Phase
Non Squamous Lung Cancer	Drug: treatment	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 343 participants
• 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.
• Actual Study Start Date: January 13, 2011
• Actual Primary Completion Date: November 30, 2013
• Actual Study Completion Date: November 30, 2016

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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).
18. 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).
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.

Wilner KD, Usari T, Polli A, Kim EE. Comparison of cardiovascular effects of crizotinib and chemotherapy in ALK-positive advanced non-small-cell lung cancer. Future Oncol. 2019 Apr;15(10):1097-1103. doi: 10.2217/fon-2018-0869. Epub 2019 Jan 17.

Solomon BJ, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Tang Y, Wilner KD, Blackhall F, Mok TS. Final Overall Survival Analysis From a Study Comparing First-Line Crizotinib Versus Chemotherapy in ALK-Mutation-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Aug 1;36(22):2251-2258. doi: 10.1200/JCO.2017.77.4794. Epub 2018 May 16.

Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.

Solomon BJ, Cappuzzo F, Felip E, Blackhall FH, Costa DB, Kim DW, Nakagawa K, Wu YL, Mekhail T, Paolini J, Tursi J, Usari T, Wilner KD, Selaru P, Mok TS. Intracranial Efficacy of Crizotinib Versus Chemotherapy in Patients With Advanced ALK-Positive Non-Small-Cell Lung Cancer: Results From PROFILE 1014. J Clin Oncol. 2016 Aug 20;34(24):2858-65. doi: 10.1200/JCO.2015.63.5888. Epub 2016 Mar 28.

Solomon BJ, Mok T, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Iyer S, Reisman A, Wilner KD, Tursi J, Blackhall F; PROFILE 1014 Investigators. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014 Dec 4;371(23):2167-77. doi: 10.1056/NEJMoa1408440. Erratum In: N Engl J Med. 2015 Oct 15;373(16):1582.

Ou SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62. doi: 10.1586/era.11.186.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01154140
• Other Study ID Numbers: A8081014; 2010-021336-33 ( EudraCT Number ); XALCORI ( Other Identifier: Alias Study Number )
• First Posted: June 30, 2010
• Results First Posted: January 5, 2015
• Last Update Posted: November 6, 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:

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms