A Phase II Study Comparing Three Months versus Two Years of Afatinib Therapy after Surgery for Patients with Stage I-III Non-Small Cell Lung Cancer

Protocol
13-096
Full Title
Randomized Phase II Study Comparing Concise (3 months) versus Prolonged (2 years) Afatinib as Adjuvant Therapy for Patients with Resected Stage I-III NSCLC with EGFR Mutation
Phase
II
Purpose

Some non-small cell lung cancers (NSCLC) are caused by a change, or mutation, in a gene called EGFR. Afatinib is an FDA-approved pill that has been shown to be active against cancers with this mutation. Erlotinib is another pill used to treat NSCLC with mutated EGFR. Prior studies have suggested that giving erlotinib for two years after surgery may delay cancer recurrence, but it is unknown if two full years of treatment are necessary.

In this study, researchers are comparing the safety and effectiveness of giving afatinib for three months versus two years in patients with EGFR-mutant NSCLC who have had their tumors surgically removed and have finished taking all standard therapies recommended by their doctors. Patients will be randomly assigned to receive afatinib, one pill by mouth daily, for three months or for two years.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage I-III NSCLC that has an EGFR mutation and was surgically removed within 6 months of entering the study. For patients who received chemotherapy and radiation therapy sequentially, up to 9 months may have passed between the surgery and study entry.
  • At least 3 weeks must have passed since completion of chemotherapy and entry into the study.
  • Patients may not have had prior therapy with drugs that target EGFR.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jamie Chaft at 646-888-4545.

Disease(s)
Lung Cancer, Non-Small Cell