Advanced NSCLC has progressed on at least one prior chemotherapy
Conditions
Sponsors
DAIICHISANKYO Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically diagnosed advanced NSCLC has progressed on at least one prior chemotherapy 2) Stage IIIB or IV disease 3) ECOG performance status: 0-1
Exclusion criteria
Exclusion criteria: 1) Has history of anti-HER3 therapy 2) Patients with active other malignancies 3) Has history or complication of any of the following diseases: 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) 4) Patients with any severe or uncontrolled comorbid medical conditions in spite of medications 5) Has brain metastasis with clinical symptoms or requiring treatment 6) Has history of bleeding diathesis (e.g., hemoptysis) 7) Has history of serious drug hypersensitivity such as anaphylactoid reaction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety CTCAE ver. 4.03 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Pharmacokinetics 2) Preliminary assessment of anti-tumor activity of U3-1287 3) Incidence of anti-U3-1287 antibody 4) Exploratory study on U3-1287-related biomarkers RECIST ver. 1.1 | — |
Outcome results
None listed