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).

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Study ID:

NCT03334487

Recruitment Status:

Withdrawn

Sponsor:

AbbVie

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There are 60 Locations for this study

See Locations Near You

Ironwood Cancer & Res Ctr /ID# 171335
Chandler Arizona, 85224, United States
Mayo Clinic - Scottsdale /ID# 171359
Scottsdale Arizona, 85259, United States
VA Central California Health C /ID# 170951
Fresno California, 93703, United States
Loma Linda University Medical /ID# 171377
Loma Linda California, 92354, United States
UC Irvine Health /ID# 171343
Orange California, 92868, United States
Kaiser Permanente - Roseville /ID# 200779
Roseville California, 95661, United States
Kaiser Permanente-Santa Clara /ID# 203024
Santa Clara California, 95051, United States
Kaiser Permanente Medical Ctr-Vallejo /ID# 169758
Vallejo California, 94589, United States
Kaiser Permanente- Walnut Creek /ID# 201305
Walnut Creek California, 94596, United States
Univ of Colorado Cancer Center /ID# 200810
Aurora Colorado, 80045, United States
Boca Raton Regional Hospital /ID# 200168
Boca Raton Florida, 33486, United States
UMHC/Sylvester Comprehensive /ID# 171462
Deerfield Beach Florida, 33442, United States
Mount Sinai Comp Cancer Ctr /ID# 169759
Miami Florida, 33140, United States
Illinois Cancer Care, PC /ID# 171310
Peoria Illinois, 61615, United States
Baptist Health /ID# 171379
Lexington Kentucky, 40503, United States
Norton Cancer Institute /ID# 200827
Louisville Kentucky, 40202, United States
Tulane Cancer Center Clinic /ID# 171376
New Orleans Louisiana, 70112, United States
Sandra Malcolm Berman Cncr Ins /ID# 171346
Baltimore Maryland, 21204, United States
St. Luke's University Hospital /ID# 171374
Duluth Minnesota, 55802, United States
Valley Hospital - Westwood, NJ /ID# 171357
Westwood New Jersey, 07675, United States
Wake Forest Baptist Medical Center /ID# 169799
Winston-Salem North Carolina, 27157, United States
The Ohio State University Comp /ID# 171352
Columbus Ohio, 43210, United States
St. Luke's Hematology Oncology /ID# 171378
Bethlehem Pennsylvania, 18015, United States
Tennessee Oncology PLLC: Sarah /ID# 171380
Nashville Tennessee, 37203, United States
Vanderbilt Ingram Henry Cancer /ID# 171356
Nashville Tennessee, 37212, United States
VCS, Virginia Cancer Specialis /ID# 169760
Arlington Virginia, 22031, United States
Kadlec Clinic Hematology and O /ID# 169797
Kennewick Washington, 99336, United States
Coffs Harbour Health Campus /ID# 200642
Coffs Harbour New South Wales, 2450, Australia
The Tweed Hospital /ID# 200646
Tweed Heads New South Wales, 2485, Australia
The Townsville Hospital /ID# 200640
Douglas Queensland, 4814, Australia
Austin Hospital /ID# 200639
Heidelberg Victoria, 3084, Australia
Border Medical /ID# 200645
Wodonga Victoria, 3690, Australia
Perron Institute for Neurological and Translational Science /ID# 200644
Nedlands Western Australia, 6009, Australia
Bahia Oncology Center - NOB /ID# 201272
Salvador Bahia, 40170, Brazil
Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 200496
Ijuí Rio Grande Do Sul, 98700, Brazil
Hospital Sao Lucas da PUCRS /ID# 201258
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Icesp /Id# 201036
São Paulo Sao Paulo, 01246, Brazil
Inca /Id# 202594
Rio de Janeiro , 20231, Brazil
Instituto COI de Educacao e Pe /ID# 200499
Rio de Janeiro , 22793, Brazil
Fundacao Antonio Prudente /ID# 200218
Sao Paulo , 01509, Brazil
Hospital de Cancer de Barretos /ID# 200104
Sao Paulo , 14784, Brazil
Tom Baker Cancer Centre /ID# 171561
Calgary Alberta, T2N 4, Canada
QE II Health Sciences Centre /ID# 171569
Halifax Nova Scotia, B3H 1, Canada
London Health Sciences Centre /ID# 171567
London Ontario, N6A 5, Canada
The Ottawa Hospital /ID# 200682
Ottawa Ontario, K1H 8, Canada
Franziskus-Hospital Harderberg /ID# 201145
Georgsmarienhütte Niedersachsen, 49124, Germany
Charite Universitatsmedizin B- /ID# 170079
Berlin , 13353, Germany
Asklepios Fachkliniken M. Gaut /ID# 170081
Gauting , 82131, Germany
Thoraxklinik Heidelberg gGmbH /ID# 170078
Heidelberg , 69126, Germany
Klinikum Kassel - Onkologie /ID# 170083
Kassel , 34125, Germany
Universitatsklinikum Munster /ID# 170087
Muenster , 48149, Germany
Pius Hospital Oldenburg /ID# 170080
Oldenburg , 26121, Germany
Akademiska Sjukhuset /ID# 171248
Uppsala Uppsala Lan, 751 8, Sweden
Gavle Hospital /ID# 171253
Gavle , 801 8, Sweden
University Hospital Linkoping /ID# 201666
Linkoping , 58185, Sweden
Karolinska University Hospital /ID# 201967
Stockholm , SE-17, Sweden
Norrlands Universitetssjukhus /ID# 171250
Umeå , 90185, Sweden
Leicester Royal Infirmary /ID# 201154
Leicester England, LE1 5, United Kingdom
Christie NHS Foundation Trust /ID# 201149
Manchester , M20 4, United Kingdom
Royal Preston Hospital /ID# 201146
Preston , PR2 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Study ID:

NCT03334487

Recruitment Status:

Withdrawn

Sponsor:


AbbVie

How clear is this clinincal trial information?

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