Clinical trial NCT03334487: 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Keywords: Cancer
Small Cell Lung Cancer
Relapsed Small Cell Lung Cancer
Remitting Small Cell Lung Cancer
Delta-like protein 3 (DLL3)
DLL3 Expressing Small Cell Lung Cancer
Rovalpituzumab Tesirine
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE
timeFrame: Approximately 32 months
Secondary outcomes:
measure: Change in Participant Reported Outcome EORTC QLQC15-PAL
timeFrame: Approximately 32 months
measure: Progression Free Survival (PFS)
timeFrame: Approximately 32 months
measure: Overall Survival (OS)
timeFrame: Approximately 32 months
measure: Objective response rate (ORR)
timeFrame: Approximately 32 months
measure: Change in EORTC QLQ-LC-13
timeFrame: Approximately 32 months
measure: Duration of Objective Response (DOR)
timeFrame: Approximately 32 months
measure: Clinical Benefit Rate (CBR)
timeFrame: Approximately 32 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Res Ctr /ID# 171335
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic - Scottsdale /ID# 171359
state: Arizona
city: Fresno
country: United States
facility: VA Central California Health C /ID# 170951
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical /ID# 171377
state: California
city: Orange
country: United States
facility: UC Irvine Health /ID# 171343
state: California
city: Roseville
country: United States
facility: Kaiser Permanente - Roseville /ID# 200779
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente-Santa Clara /ID# 203024
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Ctr-Vallejo /ID# 169758
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente- Walnut Creek /ID# 201305
state: California
city: Aurora
country: United States
facility: Univ of Colorado Cancer Center /ID# 200810
state: Colorado
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital /ID# 200168
state: Florida
city: Deerfield Beach
country: United States
facility: UMHC/Sylvester Comprehensive /ID# 171462
state: Florida
city: Miami
country: United States
facility: Mount Sinai Comp Cancer Ctr /ID# 169759
state: Florida
city: Peoria
country: United States
facility: Illinois Cancer Care, PC /ID# 171310
state: Illinois
city: Lexington
country: United States
facility: Baptist Health /ID# 171379
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute /ID# 200827
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Cancer Center Clinic /ID# 171376
state: Louisiana
city: Baltimore
country: United States
facility: Sandra Malcolm Berman Cncr Ins /ID# 171346
state: Maryland
city: Duluth
country: United States
facility: St. Luke's University Hospital /ID# 171374
state: Minnesota
city: Westwood
country: United States
facility: Valley Hospital - Westwood, NJ /ID# 171357
state: New Jersey
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center /ID# 169799
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Comp /ID# 171352
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's Hematology Oncology /ID# 171378
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology PLLC: Sarah /ID# 171380
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Ingram Henry Cancer /ID# 171356
state: Tennessee
city: Arlington
country: United States
facility: VCS, Virginia Cancer Specialis /ID# 169760
state: Virginia
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and O /ID# 169797
state: Washington
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus /ID# 200642
state: New South Wales
city: Tweed Heads
country: Australia
facility: The Tweed Hospital /ID# 200646
state: New South Wales
city: Douglas
country: Australia
facility: The Townsville Hospital /ID# 200640
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Hospital /ID# 200639
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical /ID# 200645
state: Victoria
city: Nedlands
country: Australia
facility: Perron Institute for Neurological and Translational Science /ID# 200644
state: Western Australia
city: Salvador
country: Brazil
facility: Bahia Oncology Center - NOB /ID# 201272
state: Bahia
city: Ijuí
country: Brazil
facility: Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 200496
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS /ID# 201258
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Icesp /Id# 201036
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Inca /Id# 202594
city: Rio de Janeiro
country: Brazil
facility: Instituto COI de Educacao e Pe /ID# 200499
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente /ID# 200218
city: Sao Paulo
country: Brazil
facility: Hospital de Cancer de Barretos /ID# 200104
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre /ID# 171561
state: Alberta
city: Halifax
country: Canada
facility: QE II Health Sciences Centre /ID# 171569
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre /ID# 171567
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital /ID# 200682
state: Ontario
city: Georgsmarienhütte
country: Germany
facility: Franziskus-Hospital Harderberg /ID# 201145
state: Niedersachsen
city: Berlin
country: Germany
facility: Charite Universitatsmedizin B- /ID# 170079
city: Gauting
country: Germany
facility: Asklepios Fachkliniken M. Gaut /ID# 170081
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH /ID# 170078
city: Kassel
country: Germany
facility: Klinikum Kassel - Onkologie /ID# 170083
city: Muenster
country: Germany
facility: Universitatsklinikum Munster /ID# 170087
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg /ID# 170080
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset /ID# 171248
state: Uppsala Lan
city: Gavle
country: Sweden
facility: Gavle Hospital /ID# 171253
city: Linkoping
country: Sweden
facility: University Hospital Linkoping /ID# 201666
city: Stockholm
country: Sweden
facility: Karolinska University Hospital /ID# 201967
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus /ID# 171250
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary /ID# 201154
state: England
city: Manchester
country: United Kingdom
facility: Christie NHS Foundation Trust /ID# 201149
city: Preston
country: United Kingdom
facility: Royal Preston Hospital /ID# 201146
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: