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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
Results First Submitted: November 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non Squamous Lung Cancer
Intervention: Drug: treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with histologically or cytologically proven diagnosis of locally advanced, recurrent, or metastatic non squamous non small cell lung cancer and tumors with measurable disease were enrolled. Participants were to be positive for translocation or inversion events involving the ALK gene locus as determined by an ALK break apart FISH test.

Reporting Groups
  Description
Crizotinib Crizotinib 250 mg (milligram) capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of (Response Evaluation Criteria in Solid Tumors) RECIST v1.1 defined PD, as determined by Independent Radiology Review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
Chemotherapy Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 intravenous (IV) infusion according to standard of care was administered over 10 minutes (min); either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an area under the concentration time curve (AUC) of 5 or 6 milligram*minute per millilitre (mg*min/mL), approximately 30 min after end of pemetrexed infusion.

Participant Flow:   Overall Study
    Crizotinib   Chemotherapy
STARTED   172   171 
Treated   171   169 
COMPLETED   81   69 
NOT COMPLETED   91   102 
Death                71                81 
Lost to Follow-up                4                5 
Withdrawal by Subject                12                13 
Other                3                1 
Randomized but not treated                1                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis (FA) population included all participants who were randomized with study treatment assignment designated according to the initial randomization.

Reporting Groups
  Description
Crizotinib Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
Chemotherapy Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg*min/mL, approximately 30 min after end of pemetrexed infusion.
Total Total of all reporting groups

Baseline Measures
   Crizotinib   Chemotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 172   171   343 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.94  (11.9)   52.89  (13.1)   51.92  (12.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      104  60.5%      108  63.2%      212  61.8% 
Male      68  39.5%      63  36.8%      131  38.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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) ]

3.  Secondary:   Overall Survival Probability at Month 12 and 18   [ Time Frame: Month 12, 18 ]

4.  Secondary:   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) ]

5.  Secondary:   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) ]

6.  Secondary:   Time to Tumor Response (TTR) Based on IRR   [ Time Frame: Randomization to first documentation of objective tumor response (up to 35 months) ]

7.  Secondary:   Percentage of Participants With Disease Control at Week 12 Based on IRR   [ Time Frame: Week 12 ]

8.  Secondary:   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) ]

9.  Secondary:   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) ]

10.  Secondary:   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) ]

11.  Secondary:   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) ]

12.  Secondary:   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) ]

13.  Secondary:   Percentage of Participants With Adverse Events (AEs) According to Maximum Severity   [ Time Frame: Baseline up to follow up period (up to 72 months) ]

14.  Secondary:   Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182   [ Time Frame: Predose at Day 1 of Cycle 2, 3 and 5 ]

15.  Secondary:   Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants   [ Time Frame: 28 days prior to day 1 of study treatment ]

16.  Secondary:   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) ]

17.  Secondary:   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) ]

18.  Secondary:   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) ]

19.  Secondary:   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) ]

20.  Secondary:   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) ]

21.  Secondary:   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) ]

22.  Secondary:   Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU)   [ Time Frame: Baseline up to follow up period (up to 72 months) ]

23.  Secondary:   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) ]

24.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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