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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by SFJ Pharmaceuticals, Inc.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
SFJ Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01774721
First received: January 21, 2013
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
EGFR Positive Non-small Cell Lung Cancer
Drug: Dacomitinib (PF-00299804)
Drug: Gefitinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SFJ Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Progression Free Survival per Independent Radiologic review [ Time Frame: 18 months after anticipated LSFV ] [ Designated as safety issue: No ]
    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:
  • Overall Survival (OS) and OS at 30 months (OS30m); [ Time Frame: 30 months after LSFV ] [ Designated as safety issue: No ]
  • PFS by investigator assessment [ Time Frame: 18 months after LSFV ] [ Designated as safety issue: No ]
  • Best Overall Response (BOR) [ Time Frame: 18 months after LSFV ] [ Designated as safety issue: No ]
  • Duration of Response (DR) [ Time Frame: 18 months after LSFV ] [ Designated as safety issue: No ]
  • Overall safety profile [ Time Frame: 18 months after LSFV ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes (PRO) of health related quality of life (HRQOL) [ Time Frame: 18 months after LSFV ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes (PRO) by EQ-5D [ Time Frame: 18 months after LSFV ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: April 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774721

Contacts
Contact: Karen Mosher, RN, BSN karen.mosher@sfj-pharma.com
Contact: Clinton White, PhD, MBA clinton.white@sfj-pharma.com

  Show 52 Study Locations
Sponsors and Collaborators
SFJ Pharmaceuticals, Inc.
Pfizer
Investigators
Study Director: Rolf Linke, MD SFJ Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: SFJ Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01774721     History of Changes
Other Study ID Numbers: DP312804
Study First Received: January 21, 2013
Last Updated: June 11, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
European Union: European Medicines Agency

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
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014