Afatinib Sequenced With Concurrent Chemotherapy and Radiation in EGFR-Mutant Non-Small Cell Lung Tumors: The ASCENT Trial
Study treatment will be divided into 5 stages:
Stage 1-induction, consisting of afatinib for two 4-week cycles. Afatinib is a pill that the
patient takes by mouth once per day. The patient will receive a study drug diary in which to
record the doses of afatinib.
Stage 2-concurrent radiation and chemotherapy with cisplatin/pemetrexed for two 3-week
Stage 3-Surgery to remove tumor for participants whose tumor can be removed by surgery. This
will be done about 4-6 weeks after finishing radiation and chemotherapy. The exact timing
will depend upon how quickly the patient recovers from side effects of the radiation and
chemotherapy. The investigators will use a piece of the patients tumor removed by surgery
for research tests to look for biomarkers such as genes and proteins that may be associated
with response to afatinib, chemotherapy or radiation.
Stage 4-Chemotherapy after surgery (adjuvant chemotherapy). The patients doctor will decide
if the patient will receive chemotherapy after the patients surgery but before receiving
consolidation with afatinib. If the patient does receive this, it will start 6-12 weeks
after surgery or finishing radiation if the patient does not have surgery. The chemotherapy
will be the same as that received along with the radiation therapy.
Stage 5-Consolidation with afatinib for twenty-six 4-week cycles (2 years) for participants
who responded to the 2 cycles of induction afatinib.
The investigators would like to keep track of the patients medical condition and status of
the patients disease for up to 5 years after the patient stops study treatment. Keeping in
touch with the patients and checking on the patients condition every year helps the
investigators look at the long-term effects of the research study. The patients will be
asked to have CT scans as follows:
- Every 3 months for the first year after stopping study treatment
- Every 6 months for years 2-4 after stopping study treatment
- Once per year in year 5 after stopping study treatment
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the response rate to induction afatinib.
Lecia V Sequist, MD MPH
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|