Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
452 patients were randomized in a 1:1 ratio between dacomitinib (PF-00299804 ) vs. gefitinib.
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
