Phase I Study of the Combination of Afatinib and Ruxolitinib in Patients With Treatment-refractory Non-Small Cell Lung Cancer (NSCLC)

Inclusion criteria

• Stage 4 NSCLC patients
• disease progression after platinum doublet (all), EGFR TKI (if EGFR mutant), and crizotinib (if ALK positive)
• Men and women aged 20 years or older
• Recovery from previous drug-related toxicity: CTCAE 4.03 ≤ Grade 1
• ECOG 0 or 1
• able to orally take and retain drug
• have a measurable or unmeasurable lesion under RECIST 1.1 Criteria
• have proper hematological, renal, and hepatic functions
• intention to use an acceptable contraception
• able to read and understand the informed consent form

Exclusion criteria

• previous chemotherapy, radiation therapy, immunotherapy, or other anticancer therapy within 14 days
• Clinically significant gastrointestinal disorder or malabsorption syndrome
• Acute digestive disorder
• major organ failure
• Significant cardiac disorders
• major operation of a main organ in 4 weeks
• Untreated symptomatic brain metastasis
• pregnant or nursing
• previously diagnosed Interstitial lung disease(ILD)
• previously treated with irreversible pan-HER inhibitor including Afatinib or Ruxolitinib
• previously experienced hypersensitivity to an ingredient of the study drug
• must receive CYP3A4 inducer or inhibitor persistently during the study period.
• HIV positive or active hepatitis
• threatening patient's safety is predicted