Lung Cancer Clinical Trial
Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
Summary
A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent adverse events (TEAEs).
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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There are 60 Locations for this study
Chandler Arizona, 85224, United States
Scottsdale Arizona, 85259, United States
Fresno California, 93703, United States
Loma Linda California, 92354, United States
Orange California, 92868, United States
Roseville California, 95661, United States
Santa Clara California, 95051, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Aurora Colorado, 80045, United States
Boca Raton Florida, 33486, United States
Deerfield Beach Florida, 33442, United States
Miami Florida, 33140, United States
Peoria Illinois, 61615, United States
Lexington Kentucky, 40503, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21204, United States
Duluth Minnesota, 55802, United States
Westwood New Jersey, 07675, United States
Winston-Salem North Carolina, 27157, United States
Columbus Ohio, 43210, United States
Bethlehem Pennsylvania, 18015, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37212, United States
Arlington Virginia, 22031, United States
Kennewick Washington, 99336, United States
Coffs Harbour New South Wales, 2450, Australia
Tweed Heads New South Wales, 2485, Australia
Douglas Queensland, 4814, Australia
Heidelberg Victoria, 3084, Australia
Wodonga Victoria, 3690, Australia
Nedlands Western Australia, 6009, Australia
Salvador Bahia, 40170, Brazil
Ijuà Rio Grande Do Sul, 98700, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
São Paulo Sao Paulo, 01246, Brazil
Rio de Janeiro , 20231, Brazil
Rio de Janeiro , 22793, Brazil
Sao Paulo , 01509, Brazil
Sao Paulo , 14784, Brazil
Calgary Alberta, T2N 4, Canada
Halifax Nova Scotia, B3H 1, Canada
London Ontario, N6A 5, Canada
Ottawa Ontario, K1H 8, Canada
Georgsmarienhütte Niedersachsen, 49124, Germany
Berlin , 13353, Germany
Gauting , 82131, Germany
Heidelberg , 69126, Germany
Kassel , 34125, Germany
Muenster , 48149, Germany
Oldenburg , 26121, Germany
Uppsala Uppsala Lan, 751 8, Sweden
Gavle , 801 8, Sweden
Linkoping , 58185, Sweden
Stockholm , SE-17, Sweden
Umeå , 90185, Sweden
Leicester England, LE1 5, United Kingdom
Manchester , M20 4, United Kingdom
Preston , PR2 9, United Kingdom
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