At a glance
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A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naive Patients With Advanced, EGFR Mutation Positive Non-small Cell Lung Cancer (NSCLC)
In Brief
A Phase 3 clinical trial evaluating Afatinib Dimaleate, Cetuximab, and 1 other intervention for Recurrent Non-Small Cell Lung Carcinoma and Stage IV Non-Small Cell Lung Cancer. Completed, enrolled 174 participants across 638 sites.
Detailed Summary
This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether afatinib dimaleate is more effective when given alone or with cetuximab in treating patients with non-small cell lung cancer.
Study Details
Timeline
Interventions
Given PO
Given IV
Correlative studies