ARCHER-1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC. (ARCHER 1050)
This study is currently recruiting participants.
Verified May 2013 by SFJ Pharmaceuticals, Inc.
Sponsor:
SFJ Pharmaceuticals, Inc.
Collaborator:
Pfizer
Information provided by (Responsible Party):
SFJ Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01774721
First received: January 21, 2013
Last updated: May 7, 2013
Last verified: May 2013
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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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774721
Contacts
| Contact: Rolf Linke, MD | 1-650-954-0106 | rolf.linke@sfj-pharma.com |
| Contact: Clinton White, PhD, MBA | 1-925-963-8696 | clinton.white@sfj-pharma.com |
Locations
| Japan | |
| Recruiting | |
| Chiba, Japan | |
| Recruiting | |
| Ehime, Japan | |
| Recruiting | |
| Kanagawa, Japan | |
| Recruiting | |
| Osaka, Japan | |
| Recruiting | |
| Shizouka, Japan | |
| Recruiting | |
| Tokyo, Japan | |
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: | May 7, 2013 |
| 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 Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Gefitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013