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

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.
ClinicalTrials.gov Identifier: NCT01774721
Recruitment Status : Active, not recruiting
First Posted : January 24, 2013
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
Pfizer
SFJ Lung Cancer Ltd.
Information provided by (Responsible Party):
SFJ Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
EGFR Positive Non-small Cell Lung Cancer Drug: Dacomitinib (PF-00299804) Drug: Gefitinib Phase 3

Detailed Description:
440 patients will be randomized in a 1:1 ratio between Dacomitinib (PF-00299804 ) vs. gefitinib.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Primary Completion Date : July 2016
Estimated Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Gefitinib
Gefitinib 250 mg tablets, continuous oral daily dosing.
Other Name: Iressa



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Overall Survival (OS) and OS at 30 months (OS30m); [ Time Frame: 30 months after LSFV ]
  2. PFS by investigator assessment [ Time Frame: 18 months after LSFV ]
  3. Best Overall Response (BOR) [ Time Frame: 18 months after LSFV ]
  4. Duration of Response (DR) [ Time Frame: 18 months after LSFV ]
  5. Overall safety profile [ Time Frame: 18 months after LSFV ]
  6. Patient Reported Outcomes (PRO) of health related quality of life (HRQOL) [ Time Frame: 18 months after LSFV ]
  7. Patient Reported Outcomes (PRO) by EQ-5D [ Time Frame: 18 months after LSFV ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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
Sponsors and Collaborators
SFJ Pharmaceuticals, Inc.
Pfizer
SFJ Lung Cancer Ltd.
Investigators
Study Director: Rolf Linke, MD SFJ Pharmaceuticals, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SFJ Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01774721     History of Changes
Other Study ID Numbers: DP312804
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Keywords provided by SFJ Pharmaceuticals, Inc.:
first-line
locally advanced or metastatic
non-small cell lung cancer
epidermal growth factor receptor
EGFR
Archer
mutation
dacomitinib
SFJ
PF-00299804

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action