ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.
NCT01774721
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Beijing,
- Changchun,
- Changsha,
- Chengdu,
- Chongqing,
- Fuzhou,
- Guangzhou,
- Hangzhou,
- Hefei,
- Nanning,
- Shanghai,
- Shenyang,
- Tianjin,
- Wuhan,
- Wuxi,
- Pokfulam,
- Shatin,
- Catania,
- Lecco,
- Livorno,
- Meldola,
- Milano,
- Napoli,
- Perugia,
- Ravenna,
- Roma,
- Trento,
- Viterbo,
- Hokkaido, Asahikawa
- Kashiwa, Chiba
- Matsuyama, Ehime
- Yokohama, Kanagawa
- Tokyo, Koto-ku
- Osakasayama, Osaka
- Sakai, Osaka
- Sunto-gun, Shizouka
- Chuo-Ku, Tokyo
- Seoul,
- Gdansk,
- Olsztyn,
- Poznan,
- Warszawa,
- Avila,
- Barcelona,
- Bilbao,
- Caceres,
- Cordoba,
- Las Palmas,
- Madrid,
- Malaga,
- San Sebastian,
- Seville,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC. | |||
Official Title ICMJE | 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 | |||
Brief Summary | This is a multinational, multicenter, randomized, open-label, 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. | |||
Detailed Description | 452 patients were randomized in a 1:1 ratio between dacomitinib (PF-00299804 ) vs. gefitinib. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Non-small Cell Lung Cancer With EGFR-Activating Mutations | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE | 452 | |||
Original Estimated Enrollment ICMJE | 440 | |||
Estimated Study Completion Date ICMJE | December 31, 2020 | |||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China, Hong Kong, Italy, Japan, Korea, Republic of, Poland, Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01774721 | |||
Other Study ID Numbers ICMJE | DP312804 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | SFJ Pharmaceuticals, Inc. | |||
Study Sponsor ICMJE | SFJ Pharmaceuticals, Inc. | |||
Collaborators ICMJE |
| |||
Investigators ICMJE |
| |||
PRS Account | SFJ Pharmaceuticals, Inc. | |||
Verification Date | April 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |