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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01154140




Registration number
NCT01154140
Ethics application status
Date submitted
29/06/2010
Date registered
30/06/2010
Date last updated
6/11/2017

Titles & IDs
Public title
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
Scientific 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.
Secondary ID [1] 0 0
2010-021336-33
Secondary ID [2] 0 0
A8081014
Universal Trial Number (UTN)
Trial acronym
PROFILE 1014
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Squamous Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - treatment
Treatment: Drugs - treatment

Experimental: A -

Active comparator: B -


Treatment: Drugs: treatment
crizotinib 250mg orally continuous twice daily dosing

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) Based on IRR
Timepoint [1] 0 0
Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization to death or last date known alive for those not known to have died (up to 72 months)
Secondary outcome [2] 0 0
Overall Survival Probability at Month 12 and 18
Timepoint [2] 0 0
Month 12, 18
Secondary outcome [3] 0 0
Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR
Timepoint [3] 0 0
Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Secondary outcome [4] 0 0
Duration of Response (DR) Based on IRR
Timepoint [4] 0 0
From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Secondary outcome [5] 0 0
Time to Tumor Response (TTR) Based on IRR
Timepoint [5] 0 0
Randomization to first documentation of objective tumor response (up to 35 months)
Secondary outcome [6] 0 0
Percentage of Participants With Disease Control at Week 12 Based on IRR
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Time to Progression (TTP) Based on IRR
Timepoint [7] 0 0
Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Secondary outcome [8] 0 0
Time to Intracranial Progression (IC-TTP) Based on IRR
Timepoint [8] 0 0
Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Secondary outcome [9] 0 0
Time to Extracranial Progression (EC-TTP) Based on IRR
Timepoint [9] 0 0
Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Secondary outcome [10] 0 0
Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [10] 0 0
Baseline up to follow up period (up to 72 months)
Secondary outcome [11] 0 0
Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [11] 0 0
Baseline up to follow up period (up to 72 months)
Secondary outcome [12] 0 0
Percentage of Participants With Adverse Events (AEs) According to Maximum Severity
Timepoint [12] 0 0
Baseline up to follow up period (up to 72 months)
Secondary outcome [13] 0 0
Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182
Timepoint [13] 0 0
Predose at Day 1 of Cycle 2, 3 and 5
Secondary outcome [14] 0 0
Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants
Timepoint [14] 0 0
28 days prior to day 1 of study treatment
Secondary outcome [15] 0 0
Objective Response Rate (ORR) of Anaplastic Lymphoma Kinase (ALK) Variant Groups Based on IRR
Timepoint [15] 0 0
Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Secondary outcome [16] 0 0
Time to Deterioration (TTD) in Chest Pain, Dyspnea or Cough
Timepoint [16] 0 0
From randomization of treatment up to deterioration while on study treatment (up to 35 months)
Secondary outcome [17] 0 0
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)
Timepoint [17] 0 0
Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
Secondary outcome [18] 0 0
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)
Timepoint [18] 0 0
Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
Secondary outcome [19] 0 0
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)
Timepoint [19] 0 0
Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
Secondary outcome [20] 0 0
Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)
Timepoint [20] 0 0
Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
Secondary outcome [21] 0 0
Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU)
Timepoint [21] 0 0
Baseline up to follow up period (up to 72 months)
Secondary outcome [22] 0 0
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
Timepoint [22] 0 0
Baseline up to follow up period (up to 72 months)
Secondary outcome [23] 0 0
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
Timepoint [23] 0 0
Baseline up to follow up period (up to 72 months)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2016
Sample size
Target
Accrual to date
Final
343
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Macarthur Cancer Therapy Centre - Campbelltown
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [6] 0 0
The Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [7] 0 0
Parkhaven Medical Center - Hyde Park
Recruitment hospital [8] 0 0
Department of Medical Oncology - Adelaide
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Centre, Department of Haematology and Medical Oncology - East Melbourne
Recruitment hospital [10] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2065 - St. Leonards
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
4814 - Douglas
Recruitment postcode(s) [6] 0 0
4006 - Herston
Recruitment postcode(s) [7] 0 0
4812 - Hyde Park
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3002 - East Melbourne
Recruitment postcode(s) [10] 0 0
3199 - Frankston
Recruitment outside Australia
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United States of America
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District of Columbia
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Basel
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Luzern
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Winterthur
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Kaohsiung City
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Taichung
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kyiv
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Ukraine
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Lviv
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United Kingdom
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Cambridgeshire
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Hertfordshire
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Scotland
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Aberdeen
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.
Trial website
https://clinicaltrials.gov/study/NCT01154140
Trial related presentations / publications
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. doi: 10.1056/NEJMx150034.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01154140