ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

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NCT01774721

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Study Location
Beijing, , , China
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-small Cell Lung Cancer With EGFR-Activating Mutations
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Non-small Cell Lung Cancer With EGFR-Activating MutationsARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.
NCT01774721
  1. Beijing,
  2. Changchun,
  3. Changsha,
  4. Chengdu,
  5. Chongqing,
  6. Fuzhou,
  7. Guangzhou,
  8. Hangzhou,
  9. Hefei,
  10. Nanning,
  11. Shanghai,
  12. Shenyang,
  13. Tianjin,
  14. Wuhan,
  15. Wuxi,
  16. Pokfulam,
  17. Shatin,
  18. Catania,
  19. Lecco,
  20. Livorno,
  21. Meldola,
  22. Milano,
  23. Napoli,
  24. Perugia,
  25. Ravenna,
  26. Roma,
  27. Trento,
  28. Viterbo,
  29. Hokkaido, Asahikawa
  30. Kashiwa, Chiba
  31. Matsuyama, Ehime
  32. Yokohama, Kanagawa
  33. Tokyo, Koto-ku
  34. Osakasayama, Osaka
  35. Sakai, Osaka
  36. Sunto-gun, Shizouka
  37. Chuo-Ku, Tokyo
  38. Seoul,
  39. Gdansk,
  40. Olsztyn,
  41. Poznan,
  42. Warszawa,
  43. Avila,
  44. Barcelona,
  45. Bilbao,
  46. Caceres,
  47. Cordoba,
  48. Las Palmas,
  49. Madrid,
  50. Malaga,
  51. San Sebastian,
  52. Seville,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Drug: Dacomitinib (PF-00299804)
    Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing.
    Other Name: Dacomitinib
  • Drug: Gefitinib
    Gefitinib 250 mg tablets, continuous oral daily dosing.
    Other Name: Iressa
Study Arms  ICMJE
  • Experimental: Dacomitinib (PF-00299804)
    Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing.
    Intervention: Drug: Dacomitinib (PF-00299804)
  • Active Comparator: gefitinib
    Gefitinib is provided as 250 mg tablets, continuous oral daily dosing.
    Intervention: Drug: Gefitinib
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 Unknown status
Actual Enrollment  ICMJE
 (submitted: March 29, 2018)		452
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2013)		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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
  • Pfizer
  • SFJ Lung Cancer Ltd.
Investigators  ICMJE
Study Director:Rolf Linke, MDSFJ Pharmaceuticals, Inc.
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