This is a multi-national, multi-centre, single-arm, open-label, Phase 2 clinical study of the efficacy and safety of first-line treatment with dacomitinib, with or without dose titration, in subjects with newly diagnosed stage IIIB/IV or recurrent EGFR-mutation-positive Non-small cell lung cancer (NSCLC).
Description: Proportion of subjects with a best overall response of either complete response (CR) or partial response (PR)Measure: Objective Response Rate Time: From the start of treatment until disease progression, up to 2 years
Description: Proportion of subjects with a best overall response of either CR or PR of intracranial diseaseMeasure: Intracranial Objective Response Rate Time: From the start of treatment until disease progression, up to 2 years
Single Group Assignment
There are 2 SNPs
Inclusion Criteria: - Provision of a voluntarily given, personally signed and dated, written informed consent document; - Age ≥20 years in Japan and Korea, and ≥18 years in other countries, male or female; - The presence of an EGFR activating mutation (exon 19 deletion or the L858R mutation in exon 21) in tumor specimen determined by the local laboratory; - Evidence of newly diagnosed stage IIIB/IV (based on Union for International Cancer Control (UICC) staging system version 8) or recurrent (minimum of 12 months disease free interval between completion of systemic therapy and recurrence of NSCLC required) NSCLC of adenocarcinoma histo- and/or cytopathology or its pathologically accepted variants using tumor specimen (assessed according to accepted standards by a local laboratory). --- L858R ---
Variations of adenocarcinoma are allowed, however no squamous element can be present; - An EGFR exon 20 T790M or exon 20 insertion mutation; - Symptomatic brain or leptomeningeal metastases, who are neurologically unstable or require increasing doses of steroids and/or anti-seizure medications to manage CNS symptoms within two weeks prior to starting dacomitinib; - Any previous anti-cancer systemic treatment of locally advanced, or metastatic NSCLC including but not limited to chemotherapy, targeted therapies, small molecules, EGFR-TKIs and other TKIs, monoclonal antibodies, anti-cancer vaccines, immunotherapy, radiotherapy (other than palliative radiotherapy to lesions that will not be followed for tumor assessment on this study, i.e., non-target lesions). --- T790M ---