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Brief Title: Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
Official Title: Open-Label, Single Arm, Phase 3b Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory DLL3 Expressing Small Cell Lung Cancer
Study ID: NCT03334487
Brief 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ironwood Cancer & Res Ctr /ID# 171335, Chandler, Arizona, United States
Mayo Clinic - Scottsdale /ID# 171359, Scottsdale, Arizona, United States
VA Central California Health C /ID# 170951, Fresno, California, United States
Loma Linda University Medical /ID# 171377, Loma Linda, California, United States
UC Irvine Health /ID# 171343, Orange, California, United States
Kaiser Permanente - Roseville /ID# 200779, Roseville, California, United States
Kaiser Permanente-Santa Clara /ID# 203024, Santa Clara, California, United States
Kaiser Permanente Medical Ctr-Vallejo /ID# 169758, Vallejo, California, United States
Kaiser Permanente- Walnut Creek /ID# 201305, Walnut Creek, California, United States
Univ of Colorado Cancer Center /ID# 200810, Aurora, Colorado, United States
Boca Raton Regional Hospital /ID# 200168, Boca Raton, Florida, United States
UMHC/Sylvester Comprehensive /ID# 171462, Deerfield Beach, Florida, United States
Mount Sinai Comp Cancer Ctr /ID# 169759, Miami, Florida, United States
Illinois Cancer Care, PC /ID# 171310, Peoria, Illinois, United States
Baptist Health /ID# 171379, Lexington, Kentucky, United States
Norton Cancer Institute /ID# 200827, Louisville, Kentucky, United States
Tulane Cancer Center Clinic /ID# 171376, New Orleans, Louisiana, United States
Sandra Malcolm Berman Cncr Ins /ID# 171346, Baltimore, Maryland, United States
St. Luke's University Hospital /ID# 171374, Duluth, Minnesota, United States
Valley Hospital - Westwood, NJ /ID# 171357, Westwood, New Jersey, United States
Wake Forest Baptist Medical Center /ID# 169799, Winston-Salem, North Carolina, United States
The Ohio State University Comp /ID# 171352, Columbus, Ohio, United States
St. Luke's Hematology Oncology /ID# 171378, Bethlehem, Pennsylvania, United States
Tennessee Oncology PLLC: Sarah /ID# 171380, Nashville, Tennessee, United States
Vanderbilt Ingram Henry Cancer /ID# 171356, Nashville, Tennessee, United States
VCS, Virginia Cancer Specialis /ID# 169760, Arlington, Virginia, United States
Kadlec Clinic Hematology and O /ID# 169797, Kennewick, Washington, United States
Coffs Harbour Health Campus /ID# 200642, Coffs Harbour, New South Wales, Australia
The Tweed Hospital /ID# 200646, Tweed Heads, New South Wales, Australia
The Townsville Hospital /ID# 200640, Douglas, Queensland, Australia
Austin Hospital /ID# 200639, Heidelberg, Victoria, Australia
Border Medical /ID# 200645, Wodonga, Victoria, Australia
Perron Institute for Neurological and Translational Science /ID# 200644, Nedlands, Western Australia, Australia
Bahia Oncology Center - NOB /ID# 201272, Salvador, Bahia, Brazil
Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 200496, Ijuí, Rio Grande Do Sul, Brazil
Hospital Sao Lucas da PUCRS /ID# 201258, Porto Alegre, Rio Grande Do Sul, Brazil
Icesp /Id# 201036, São Paulo, Sao Paulo, Brazil
Inca /Id# 202594, Rio de Janeiro, , Brazil
Instituto COI de Educacao e Pe /ID# 200499, Rio de Janeiro, , Brazil
Fundacao Antonio Prudente /ID# 200218, Sao Paulo, , Brazil
Hospital de Cancer de Barretos /ID# 200104, Sao Paulo, , Brazil
Tom Baker Cancer Centre /ID# 171561, Calgary, Alberta, Canada
QE II Health Sciences Centre /ID# 171569, Halifax, Nova Scotia, Canada
London Health Sciences Centre /ID# 171567, London, Ontario, Canada
The Ottawa Hospital /ID# 200682, Ottawa, Ontario, Canada
Franziskus-Hospital Harderberg /ID# 201145, Georgsmarienhütte, Niedersachsen, Germany
Charite Universitatsmedizin B- /ID# 170079, Berlin, , Germany
Asklepios Fachkliniken M. Gaut /ID# 170081, Gauting, , Germany
Thoraxklinik Heidelberg gGmbH /ID# 170078, Heidelberg, , Germany
Klinikum Kassel - Onkologie /ID# 170083, Kassel, , Germany
Universitatsklinikum Munster /ID# 170087, Muenster, , Germany
Pius Hospital Oldenburg /ID# 170080, Oldenburg, , Germany
Akademiska Sjukhuset /ID# 171248, Uppsala, Uppsala Lan, Sweden
Gavle Hospital /ID# 171253, Gavle, , Sweden
University Hospital Linkoping /ID# 201666, Linkoping, , Sweden
Karolinska University Hospital /ID# 201967, Stockholm, , Sweden
Norrlands Universitetssjukhus /ID# 171250, Umeå, , Sweden
Leicester Royal Infirmary /ID# 201154, Leicester, England, United Kingdom
Christie NHS Foundation Trust /ID# 201149, Manchester, , United Kingdom
Royal Preston Hospital /ID# 201146, Preston, , United Kingdom
Name: AbbVie Inc.
Affiliation: AbbVie
Role: STUDY_DIRECTOR