Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT01898156
Eligibility Criteria:
Inclusion Criteria:
* Phase 1: histopathological-documented, measurable or non-measurable unresectable, advanced primary or recurrent SCLC, NSCLC or mesothelioma
* Phase 2: measurable, unresectable advanced or recurrent SCLC
* A life expectancy \> 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 at study entry
* Echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) ≥ 50%, or ≥ institution's established lower limit of normal
* Adequate hematologic, hepatic, renal and lung function
Exclusion Criteria:
* Subject received cytotoxic anti-cancer chemotherapy, orally available signaling pathway-targeted therapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 3 weeks prior to the first dose
* Subject received monoclonal antibodies within 4 weeks of the first dose
* Major surgery within 4 weeks prior to the first dose
* Known symptomatic brain metastases
* Clinically significant cardiovascular disease
* Leptomeningeal disease
* Uncontrolled intercurrent illness including ongoing or active infection, uncontrolled diabetes, etc
* Known HIV disease or acquired immunodeficiency syndrome-related illness
* A psychiatric illness, disability or social situation
* Hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins
* A history of primary brain/CNS malignancy
* Neurological paraneoplastic syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01898156
Study Brief:
Protocol Section:
NCT01898156