Randomized Phase II Study Comparing Concise Versus Prolonged Afatinib as Adjuvant Therapy for Patients With Resected Stage I-III NSCLC With EGFR Mutation
In order to determine if one is eligible to participate in this study they would be asked to
undergo some screening tests or procedures. Many of these tests and procedures are likely to
be part of regular cancer care and may be done even if it turns out that one does not take
part in the research study. If the patient has had some of these tests or procedures
recently, they may or may not have to be repeated. These tests and procedures include: a
medical history, performance status, physical exam and vital signs including height and
weight, an assessment of your tumor, routine blood tests, pregnancy test, electrocardiogram,
echocardiogram and/or multigated acquisition scan. If these tests show that a patient is
eligible to participate in the research study, they will begin the study treatment. If one
does not meet the eligibility criteria, they will not be able to participate in this
Because no one knows which of the study options is best, the patients will be "randomized"
into one of the study groups. They will take afatinib by mouth every day for either 3 months
(short course) or for 2 years (long course). Randomization means that one is put into a
group by chance. It is like flipping a coin. Neither the patient, nor the research doctor
will choose what group the patient will be in. You will have a 50/50 chance of being placed
in any group.
Regardless of which study group one is put in, all patients will take afatinib by mouth
every day. The first cycle will last 28 days. All cycles after that will last 25-31 days.
Patients will take their medication (tablets) by mouth once a day, at about the same time
each day. They should take afatinib with a glass of water. Afatinb treatment will continue
until the assigned course is completed, or until there are side effects that cannot be
tolerated, or one decides to stop study treatment, of if the lung cancer returns.
Patients will be asked to come to the clinic at the following time points:
- Day 1 and 8 of Cycle 1
- Day 1 of Cycles 2, 3 and 4
- Off treatment visit-28 days after the last dose of study drug
If one is assigned to the long course, one will also need to come in for clinic visits on
Day 1 of Cycles 7, 10, 13, 16, 19, 22 and 25. If one is assigned to the short course, one
does not need to come in for these additional clinic visits.
The following tests and procedures will be done to monitor for side effects of afatinib.
- Routine blood tests-about 2 tablespoons of blood
- Performance status
- Physical exam and vital signs, including height and weight
The following tests and procedures will be done to monitor for recurrence of lung cancer.
These visits are the same, regardless of whether one is taking a short course, or a long
course of afatinib. There will be clinic visits once every 6 months for 3 years (months 7,
13, 19, 25, 31, 37 and 49), and then one more visit 1 year later. The following tests and
procedures will be done at these follow up visits: a CT scan of the chest, routine blood
tests, performance status and a physical exam, including height and weight.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of this study is to demonstrate that prolonged adjuvant therapy with afatinib will improve recurrence free survival (RFS) compared to a concise adjuvant course in patients with resected stage I-III non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation.
Lecia Sequist, MD, MPH
Massachusetts General Hospital
United States: Food and Drug Administration
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