A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

Inclusion criteria

• Ability to understand and willingness to sign a written informed consent document;
• Male or female adult patients 18 years of age or older;
• Patients should have recovered from toxicities related to prior anti-tumor therapy;
• Patients should have recovered from the effects of major surgery;
• Have a documented EGFR mutation by a local test in tissue or plasma;
• At least 12 weeks life expectancy;
• Must have at least one measurable lesion per RECIST v 1.1;
• Sexually active males and females of childbearing potential must agree to take effective contraceptive measures.

Exclusion criteria

• Received radiotherapy within 14 days before enrollment;
• Have significant or uncontrolled systemic disease;
• Have significant or uncontrolled cardiovascular disease;
• Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC;
• Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy;
• Have known hypersensitivity to the similar drugs and excipients of PLB1004;
• Pregnant or lactating women;
• Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004;
• Have any condition or illness that could affect the compliance with the protocol.