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ARCHER-1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC. (ARCHER 1050)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
SFJ Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01774721
First received: January 21, 2013
Last updated: April 24, 2017
Last verified: April 2017
January 21, 2013
April 24, 2017
April 2013
July 2016   (Final data collection date for primary outcome measure)
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).
Progression Free Survival per Independent Radiologic review [ Time Frame: 18 months after anticipated LSFV ]
The purpose of this trial is to determine if PF-00299804 (dacomitinib) 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).
Complete list of historical versions of study NCT01774721 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
ARCHER-1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.
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
This is a multinational, multicenter, randomized, open-labeled, Phase 3 study comparing the efficacy and safety of treatment with Dacomitinib (PF-00299804) to treatment with gefitinib in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal growth factor receptor (EGFR) activating mutation (s). Analyses of primary objective (Progression Free Survival) will be done as defined in the protocol.
440 patients will be randomized in a 1:1 ratio between Dacomitinib (PF-00299804 ) vs. gefitinib.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
EGFR Positive Non-small Cell Lung Cancer
  • Drug: Dacomitinib (PF-00299804)
    Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing.
    Other Name: Dacomitinib
  • Drug: Gefitinib
    Gefitinib 250 mg tablets, continuous oral daily dosing.
    Other Name: Iressa
  • Experimental: Dacomitinib (PF-00299804)
    Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing.
    Intervention: Drug: Dacomitinib (PF-00299804)
  • Active Comparator: gefitinib
    Gefitinib is provided as 250 mg tablets, continuous oral daily dosing.
    Intervention: Drug: Gefitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
440
September 2017
July 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Evidence of histo or cytopathology confirmed, advanced NSCLC (with known histology) with the presence of EGFR activating mutation (exon 19 deletion or the L858R mutation in exon 21).
  • It is acceptable for subjects with the presence of the exon 20 T790M mutation together with either EGFR activating mutation (exon 19 deletion or the L858R mutation in exon 21) to be included in this study
  • Minimum of 12 months disease free interval between completion of systemic therapy and recurrence of NSCLC
  • Adequate tissue sample must be available for central analyses.
  • Adequate renal, hematologic, liver function.
  • ECOG PS of 0-1.
  • Radiologically measurable disease.

Exclusion Criteria:

  • Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer.
  • Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation.
  • Any history of brain mets or leptomeningeal mets.
  • Any previous anti-cancer systemic treatment of early, locally advanced, or metastatic NSCLC.
  • Uncontrolled medical disorders.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Poland,   Spain
 
 
NCT01774721
DP312804
Yes
Not Provided
Not Provided
SFJ Pharmaceuticals, Inc.
SFJ Pharmaceuticals, Inc.
Pfizer
Study Director: Rolf Linke, MD SFJ Pharmaceuticals, Inc.
SFJ Pharmaceuticals, Inc.
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP