The purpose of this Phase I study is to test the safety of combining afatinib with standard chemotherapy and radiation. The drug afatinib will be given before the chemotherapy and radiation therapy to shrink the tumor and evaluate how afatinib affects the patient. This study will then test the safety of afatinib at different dose levels when combined with the chemotherapy drugs cisplatin or carboplatin, and pemetrexed. These treatments will be given during radiation treatment and the drug afatinib will be continued after chemotherapy and radiation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
maximum tolerated dose
This will be defined as the dose at which fewer than 1:6 patients experiences a dose-limiting toxicity.
Time frame: 1 year
local control rate
will be determined as the proportion of patients who start the concurrent phase who are alive and free of local failure.
Time frame: at 1 year and at 2 years
tolerability of adjuvant afatinib
Tolerability will be defined by in terms of dose reductions, delays and discontinuations of patients who have not had disease progression or death.
Time frame: at 3 months
median progression free survival
PFS is defined as the duration of time from start of treatment to time of progression of disease or death, whichever occurs first.
Time frame: 2 years
median overall survival
will be calculated using Kaplan-Meier estimates among all patients enrolled.
Time frame: 2 years
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