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Sponsor: Pfizer
Conditions: Non-small Cell Lung Cancer With EGFR-Activating Mutations
Interventions: Dacomitinib (PF-00299804), Gefitinib
Countries: China, Hong Kong, Italy, Japan, Poland, South Korea, Spain
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.
Sex: ALL
Age: 18 Years to 99 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Beijing, China
- Changchun, China
- Changsha, China
- Chengdu, China
- Chongqing, China
- Fuzhou, China
- Guangzhou, China
- Hangzhou, China
- Hefei, China
- Nanning, China
- Shanghai, China
- Shenyang, China
- Tianjin, China
- Wuhan, China
- Wuxi, China
- Hong Kong, Hong Kong
- Shatin, Hong Kong
- Catania, Italy
- Lecco, Italy
- Livorno, Italy
- Meldola, Italy
- Milan, Italy
- Naples, Italy
- Perugia, Italy
- Ravenna, Italy
- Roma, Italy
- Trento, Italy
- Viterbo, Italy
- Hokkaido, Asahikawa, Japan
- Kashiwa, Chiba, Japan
- + 22 more on CT.gov