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

About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
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 in-frame exon 20 insertion 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.
Sites / Locations
- Nebraska Cancer Specialists
Arms of the Study
Arm 1
Experimental
PLB1004
PLB1004 given as a mono-therapy in dose escalation and dose expansion phase.