Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Minimum life expectancy of at least 12 weeks.
Laboratory values meeting the criteria specified in the protocol.
Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen.
Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked or otherwise representative tumor tissue.
Measurable disease as described per protocol.
In participants with a history of central nervous system (CNS) metastases, documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of study drug, off or on a stable dose of corticosteroids.
You may not be if
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III - IV within 6 months prior to first dose of study drug.
Recent or on-going serious infection.
History of other invasive malignancy that has not been in remission for at least 3 years.
History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation.
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.
Documented history of capillary leak syndrome.
Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing requirements for pericardiocentesis or thoracentesis.
Clareo Health | Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
