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Afatinib Sequenced With Concurrent Chemotherapy and Radiation in EGFR-Mutant Non-Small Cell Lung Tumors: The ASCENT Trial

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

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

Inclusion Criteria:

- Histologically confirmed stage IIIA NSCLC

- Measurable disease

- Have lung cancer harboring an EGFR mutation

- Must be evaluated by a medical oncologist, radiation oncologist and thoracic surgeon
within 4 weeks of enrollment into study to document that they are a candidate for
chemoradiation and for consideration of surgical resection (not required to be a
surgical candidate)

Exclusion Criteria:

- Pregnant or breastfeeding

- Prior EGFR TKI therapy

- Prior treatment with radiation to the thoracic region (including breast irradiation)

- Known pre-existing interstitial lung disease

- Significant or recent gastrointestinal disorders with diarrhea as a major symptom

- History or presence of relevant cardiovascular abnormalities

- Any other concomitant serious illness or organ system dysfunction

- Active hepatitis B, C or known HIV carrier

- Known or suspected active drug or alcohol use

- Known hypersensitivity to afatanib, cisplatin, or pemetrexed

- Concomitant treatment with strong inhibitor of P-gp

- History of an active malignancy within the last 3 years

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Description:

Assess the response rate to induction afatinib.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lecia V Sequist, MD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

December 2015

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617