Lung Cancer Clinical Trial
Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer
The purpose of this study is to test the safety of dacomitinib and osimertinib, at increasing doses, to find out what effects, if any, this combination of drugs has on people with metastatic EGFR mutant lung cancer that has not been treated with an EGFR TKI.
Written informed consent
Advanced biopsy-proven metastatic non-small cell lung cancer
Somatic activating mutation in EGFR in a tumor biopsy
No prior EGFR inhibitor treatment (gefitinib, afatinib, erlotinib, dacomitinib, osimertinib) however, prior treatment with other chemotherapies are allowed
Archival tissue available from a pre-treatment tumor biopsy or willing to undergo a tumor biopsy prior to study initiation.
Measurable (RECIST 1.1) indicator lesion not previously irradiated
Karnofsky performance status (KPS) ≥ 70%
Age >18 years old
Ability to swallow oral medication
Agree to use effective methods of contraception from the time of screening until 3 months after treatment discontinuation (for males and females of child-bearing potential)
Adequate organ function
AST, ALT ≤ 3 x ULN
Total bilirubin ≤1.5x ULN
Creatinine ≤ 1.5x ULN OR calculated creatinine clearance ≥ 60ml/min
Absolute neutrophil count (ANC) ≥ 1000 cells/mm^3
Pregnant or lactating women
Any radiotherapy within 1 week of starting treatment on protocol.
Any major surgery within 1 weeks of starting treatment on protocol.
Any evidence of active clinically significant interstitial lung disease
A mean QTc >470ms (Fridericia"s correction), clinically important arrhythmia, conduction or morphology of resting ECG (eg complete LBBB, 1st -3rd degree heart block, any factors that increase the risk of QTc prolongation or risk of arrhythmia)
Cardiovascular disease or cerebrovascular disease, CVA or MI < 6 months prior to study enrollment, unstable angina, NYHA >Grade II CHF, or serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment
History of pneumonitis or interstitial lung disease (ILD), drug induced ILD, radiation pneumonitits that required steroid treatment, and any evidence of clinically active ILD
Serious chronic GI conditions associated with diarrhea
Symptomatic, unstable brain metastases requiring escalating doses of steroids
Continue to have unresolved > CTCAE grade 1 toxicity from any previous treatment
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There are 7 Locations for this study
Basking Ridge New Jersey, 07920, United States
Middletown New Jersey, 07748, United States
Montvale New Jersey, 07645, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Uniondale New York, 11553, United States
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