Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer

Korábbi kezelés

• Any radiotherapy within 1 week of starting treatment on protocol.
• Any major surgery within 1 weeks of starting treatment on protocol.
• 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
• Symptomatic, unstable brain metastases requiring escalating doses of steroids
• Continue to have unresolved > CTCAE grade 1 toxicity from any previous treatment

Más betegség

• Any evidence of active clinically significant interstitial lung disease
• 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

Laborértékek

• 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)

Egyéb

• Pregnant or lactating women

• 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
  • Hemoglobin≥9.0 g/dL
  • Platelets ≥100,000/mm\^3