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
18 Years
N/A
Both
EGFR Positive Non-small Cell Lung Cancer
Trial Information
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
440 patients will be randomized in a 1:1 ratio between Dacomitinib (PF-00299804 ) vs.
gefitinib.
Inclusion Criteria:
- Evidence of pathologically 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
- No prior treatment with systemic therapy for 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival per Independent Radiologic review
Outcome Description:
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).
Outcome Time Frame:
18 months after anticipated LSFV
Safety Issue:
No
Principal Investigator
Rolf Linke, MD
Investigator Role:
Study Director
Investigator Affiliation:
SFJ Pharmaceuticals, Inc.
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
DP312804
NCT ID:
NCT01774721
Start Date:
April 2013
Completion Date:
December 2016
Related Keywords:
- EGFR Positive Non-small Cell Lung Cancer
- first-line
- locally advanced or metastatic
- non-small cell lung cancer
- epidermal growth factor receptor
- EGFR
- Archer
- mutation
- dacomitinib
- SFJ
- PF-00299804
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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