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Trial record 1 of 1 for:    A7471009
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ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer (ARCHER 1009)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01360554
First received: April 12, 2011
Last updated: April 24, 2017
Last verified: April 2017
Results First Received: September 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: Dacomitinib (PF-00299804)
Drug: Active Comparator (erlotinib)
Drug: Placebo erlotinib
Drug: Placebo PF00299804

  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
The study was conducted at 134 sites with 878 participants randomized in a 1:1 ratio to 1 of 2 treatment arms, of these 872 were treated. Eligible participants who provided written informed consent and met all inclusion and exclusion criteria were assigned a Single Subject Identification number and randomized by the central randomization system.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no significant study milestones following participant enrollment, but prior to group assignment.

Reporting Groups
  Description
Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.

Participant Flow:   Overall Study
    Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)   Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)
STARTED   439 [1]   439 [1] 
Treated   436   436 
COMPLETED   0   0 
NOT COMPLETED   439   439 
Death                359                371 
Lost to Follow-up                4                4 
Withdrawal by Subject                23                24 
Study terminated by sponsor                49                37 
Other, not specified                1                0 
Randomized but not treated.                3                3 
[1] Three participants were randomized but not treated.



  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 baseline analysis population included all treated participants.

Reporting Groups
  Description
Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo) Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
Total Total of all reporting groups

Baseline Measures
   Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)   Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 436   436   872 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.3  (9.57)   61.7  (9.71)   62.5  (9.67) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      150  34.4%      161  36.9%      311  35.7% 
Male      286  65.6%      275  63.1%      561  64.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS) Per Independent Radiologic Review.   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]

2.  Primary:   Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]

3.  Secondary:   PFS Based on Investigator Review.   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]

4.  Secondary:   PFS Based on Investigator Review in KRAS-WT Participants.   [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]

5.  Secondary:   Overall Survival (OS).   [ Time Frame: From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months. ]

6.  Secondary:   OS in KRAS-WT Participants.   [ Time Frame: From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months. ]

7.  Secondary:   Best Overall Response (BOR) Per Independent Radiologic Review.   [ Time Frame: From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]

8.  Secondary:   BOR Per Investigator Review.   [ Time Frame: From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]

9.  Secondary:   Duration of Response (DR) Based on Independent Radiologic Review.   [ Time Frame: From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]

10.  Secondary:   DR Based on Investigator Review.   [ Time Frame: From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]

11.  Secondary:   Trough Concentrations (Ctrough) of Dacomitinib.   [ Time Frame: Baseline up to Cycle 5 Day 1 ]

12.  Secondary:   Trough Concentrations (Ctrough) of PF-05199265.   [ Time Frame: Baseline up to Cycle 5 Day 1 ]

13.  Secondary:   Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms.   [ Time Frame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal. ]

14.  Secondary:   Mean and Difference in Mean 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: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. ]

15.  Secondary:   Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30.   [ Time Frame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. ]

16.  Secondary:   Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13.   [ Time Frame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. ]

17.  Secondary:   Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score   [ Time Frame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. ]


  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 NOT 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.


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: NCT01360554     History of Changes
Other Study ID Numbers: A7471009
2010-022656-22 ( EudraCT Number )
Study First Received: April 12, 2011
Results First Received: September 7, 2016
Last Updated: April 24, 2017