ARCHER-1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC. (ARCHER 1050)
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|ClinicalTrials.gov Identifier: NCT01774721|
Recruitment Status : Active, not recruiting
First Posted : January 24, 2013
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|EGFR Positive Non-small Cell Lung Cancer||Drug: Dacomitinib (PF-00299804) Drug: Gefitinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||ARCHER 1050: A Randomized, Open Label Phase 3 Efficacy and Safety Study Of Dacomitinib (PF-00299804) Vs. Gefitinib For The First-Line Treatment Of Locally Advanced or Metastatic NSCLC In Subjects With EGFR Activating Mutations|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||March 29, 2019|
Experimental: Dacomitinib (PF-00299804)
Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing.
Drug: Dacomitinib (PF-00299804)
Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing.
Other Name: Dacomitinib
Active Comparator: gefitinib
Gefitinib is provided as 250 mg tablets, continuous oral daily dosing.
Gefitinib 250 mg tablets, continuous oral daily dosing.
Other Name: Iressa
- Progression Free Survival per Independent Radiologic review [ Time Frame: 18 months after anticipated LSFV ]The purpose of this trial is to determine if Dacomitinib (PF-00299804) can extend progression free survival vs. gefitinib in the first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) activating mutation (s).
- Overall Survival (OS) and OS at 30 months (OS30m); [ Time Frame: 30 months after LSFV ]
- PFS by investigator assessment [ Time Frame: 18 months after LSFV ]
- Best Overall Response (BOR) [ Time Frame: 18 months after LSFV ]
- Duration of Response (DR) [ Time Frame: 18 months after LSFV ]
- Overall safety profile [ Time Frame: 18 months after LSFV ]
- Patient Reported Outcomes (PRO) of health related quality of life (HRQOL) [ Time Frame: 18 months after LSFV ]
- Patient Reported Outcomes (PRO) by EQ-5D [ Time Frame: 18 months after LSFV ]
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): NCT01774721
Show 52 Study Locations
|Study Director:||Rolf Linke, MD||SFJ Pharmaceuticals, Inc.|