A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Vs. Afatinib Alone in Treatment-Naive Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC) (BI 1200.124)

December 16, 2015
Lung Cancer
Amaryllis Gil, MD

This randomized phase II/III trial studies how well afatinib with cetuximab works and compares it with afatinib 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 (NSCLC). Afatinib 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 is more effective when given alone or with cetuximab in treating patients with non-small cell lung cancer.

View more information about S1403 at ClinicalTrials.gov

  • Patients must have histologically or cytologically confirmed stage IV or recurrent non-small cell lung cancer (NSCLC).
  • Patients must have documented presence of an EGFR exon 19 deletion or exon 21 (L858R) substitution mutation.
  • Patients must not have received any prior systemic anticancer therapy for advanced or metastatic disease including chemotherapy or EGFR tyrosine kinase inhibitor; prior chemotherapy for non-metastatic disease is allowed as long as > 12 months has passed since completion of therapy.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
  • This is a partial list of eligibility criteria. 
Until disease gets worse or the side effects become too severe and up to 3 years of follow-up visits.
Accepting Participants
Kathy Seymour, BSN
(331) 221-2168