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Randomized Phase II Study Comparing Concise Versus Prolonged Afatinib as Adjuvant Therapy for Patients With Resected Stage I-III NSCLC With EGFR Mutation

Phase 2
18 Years
Open (Enrolling)
Non Small Cell Lung Cancer

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Trial Information

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
research study.

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.

Inclusion Criteria:

- Pathologically confirmed diagnosis of non-small cell lung cancer with EGFR mutation

- Complete surgical resection, pathologic stage IA-B, IIA-B, IIIA-B by AJCC 7th Edition
staging criteria

- Surgical resection with curative intent was at least 6 months prior to enrollment

- At least 3 weeks have passed since completion of adjuvant chemotherapy or

Exclusion Criteria:

- Pregnant or breastfeeding

- History of allergic reactions attributed to compounds of similar chemical composition
to afatinib

- Prior exposure to EGFR tyrosine kinase inhibitor

- Evidence of clinically active interstitial lung disease

- Radiographic evidence of recurrent NSCLC prior to afatinib treatment

- Receipt of any experimental treatment within 30 days of start of treatment with
afatinib until the end of treatment visit

- Use of potent P-gp inhibitors and potent P-gp inducers must be avoided during
treatment with afatinib

- Individuals with a history of a different malignancy (except: synchronous or
metachronous primary non-small cell lung cancers of lower stage than the cancer for
which adjuvant treatment is currently being prescribed; disease free for at least 3
years; cervical cancer in situ; basal or squamous cell carcinoma of the skin)

- HIV positive on combination antiretroviral therapy

- Uncontrolled intercurrent illness

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence-free survival

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lecia Sequist, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

January 2013

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • EGFR mutation
  • Resected
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Massachusetts General HospitalBoston, Massachusetts  02114-2617