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

Launched by PFIZER · Jan 21, 2013

Keywords

ClinConnect Summary

452 patients were randomized in a 1:1 ratio between dacomitinib (PF-00299804 ) vs. gefitinib.

Gender

ALL

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.