ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.
Condition: Non-small Cell Lung Cancer With EGFR-Activating Mutations
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Dacomitinib (PF-00299804); Gefitinib
Intervention description: Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing.; Gefitinib 250 mg tablets, continuous oral daily dosing.
Intervention MeSH terms: Gefitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 452.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: first-line; locally advanced or metastatic; non-small cell lung cancer; epidermal growth factor receptor; EGFR; ARCHER; mutation; dacomitinib; PF-00299804

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.
    

Eligibility 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

          -  No prior treatment with systemic therapy for locally advanced or metastatic NSCLC.
             Minimum of 12 months disease free interval between completion of neoadjuvant/adjuvant
             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 metastases or leptomeningeal metastases.

          -  Any previous anti-cancer systemic treatment of early, locally advanced, or metastatic
             NSCLC.

          -  Any surgery(not including minor procedures such as lymph node biopsy), palliative
             radiotherapy or pleurodesis within 2 weeks of baseline assessments

          -  Any clinically significant gastrointestinal abnormalities that may impair intake,
             transit or absorption of the study drug.

          -  Current enrollment in another therapeutic clinical study.

          -  History of, or currently suspected, diffuse non-infectious pneumonitis or interstitial
             lung disease

          -  Uncontrolled medical disorders.

          -  Prior malignancy and concurrent malignancy except for non melanoma skin cancer or
             in-situ cervical cancer with no evidence of active disease.

          -  Use of narrow therapeutic index drugs that are CYP2D6 substrates from screening to
             randomization.