Advanced NSCLC has progressed on at least one prior chemotherapy
Conditions
Sponsors
DAIICHISANKYO Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically or cytologically diagnosed advanced NSCLC has progressed on at least one prior chemotherapy -Stage IIIB or IV disease -Measurable tumour lesions and malignant lymph nodes per RECIST ver 1.1 -ECOG performance status: 0-1
Exclusion criteria
Exclusion criteria: -Has history of erlotinib or anti-HER3 therapy -Patients with active other malignancies -History of any of the following diseases or comorbid medical conditions: interstitial lung disease, heart failure, myocardial infarction, cerebral infarction, active angina, arrhythmia requiring medication, coronary/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thrombosis, deep vein thrombosis, other clinically significant thromboembolic events, diverticulitis, or clinically significant pulmonary disease (e.g., lung infection, COPD, or asthma) -Patients with any severe or uncontrolled comorbid medical conditions in spite of medications -Has brain metastasis with clinical symptoms or requiring treatment -Has history of bleeding diathesis (e.g., hemoptysis) -Has history of serious drug hypersensitivity such as anaphylactoid reaction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Safety and pharmacokinetics -Determination of the recommended dose of U3-1287 for ubsequent clinical studies -NCI-CTC ver. 4.03 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Preliminary assessment of anti-tumor activity of U3-1287 -Incidence of anti-U3-1287 antibody -Exploratory study on U3-1287-related biomarkers -RECIST ver. 1.1 | — |
Outcome results
None listed