Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
- Conditions
- Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT03334487
- Lead Sponsor
- AbbVie
- 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
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rovalpituzumab tesirine + dexamethasone Dexamethasone Rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle plus oral dexamethasone 8 mg twice daily on Day -1, Day 1, and Day 2 of 6-week each cycle. Rovalpituzumab tesirine + dexamethasone Rovalpituzumab tesirine Rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle plus oral dexamethasone 8 mg twice daily on Day -1, Day 1, and Day 2 of 6-week each cycle.
- Primary Outcome Measures
Name Time Method Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE Approximately 32 months Number of participants with a high grade (≥ Grade 3) protocol specified Treatment-Emergent Adverse Events (TEAEs) during and after treatment with rovalpituzumab tesirine. Severity of TEAEs will be graded at each study visit according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.
- Secondary Outcome Measures
Name Time Method Change in Participant Reported Outcome EORTC QLQC15-PAL Approximately 32 months The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Palliative Cancer (EORTC QLQ-C15-PAL) is a 15-item self-report questionnaire composed of 4 multi-item scales (physical \& emotional functioning, fatigue and pain) along with 6 individual items (nausea \& vomiting, dyspnea, insomnia, appetite loss, constipation, and global quality of life).
Progression Free Survival (PFS) Approximately 32 months PFS is based on independent review of radiographic assessment, defined as the time from randomization to documented disease progression or death from any cause, whichever occurs earlier.
Change in EORTC QLQ-LC-13 Approximately 32 months The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer (EORTC QLQ-LC 13) is a lung cancer specific module developed to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients.
Clinical Benefit Rate (CBR) Approximately 32 months CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD) according to RECIST version 1.1.
Objective response rate (ORR) Approximately 32 months ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Duration of Objective Response (DOR) Approximately 32 months DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST version 1.1) or death due to any cause, whichever comes first.
Overall Survival (OS) Approximately 32 months Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.
Trial Locations
- Locations (60)
VA Central California Health C /ID# 170951
🇺🇸Fresno, California, United States
St. Luke's University Hospital /ID# 171374
🇺🇸Duluth, Minnesota, United States
Bahia Oncology Center - NOB /ID# 201272
🇧🇷Salvador, Bahia, Brazil
Loma Linda University Medical /ID# 171377
🇺🇸Loma Linda, California, United States
The Ohio State University Comp /ID# 171352
🇺🇸Columbus, Ohio, United States
Ironwood Cancer & Res Ctr /ID# 171335
🇺🇸Chandler, Arizona, United States
Boca Raton Regional Hospital /ID# 200168
🇺🇸Boca Raton, Florida, United States
UMHC/Sylvester Comprehensive /ID# 171462
🇺🇸Deerfield Beach, Florida, United States
Illinois Cancer Care, PC /ID# 171310
🇺🇸Peoria, Illinois, United States
Norton Cancer Institute /ID# 200827
🇺🇸Louisville, Kentucky, United States
Wake Forest Baptist Medical Center /ID# 169799
🇺🇸Winston-Salem, North Carolina, United States
Sandra Malcolm Berman Cncr Ins /ID# 171346
🇺🇸Baltimore, Maryland, United States
Valley Hospital - Westwood, NJ /ID# 171357
🇺🇸Westwood, New Jersey, United States
VCS, Virginia Cancer Specialis /ID# 169760
🇺🇸Arlington, Virginia, United States
Coffs Harbour Health Campus /ID# 200642
🇦🇺Coffs Harbour, New South Wales, Australia
The Townsville Hospital /ID# 200640
🇦🇺Douglas, Queensland, Australia
The Tweed Hospital /ID# 200646
🇦🇺Tweed Heads, New South Wales, Australia
Hospital Sao Lucas da PUCRS /ID# 201258
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Icesp /Id# 201036
🇧🇷São Paulo, Sao Paulo, Brazil
Hospital de Cancer de Barretos /ID# 200104
🇧🇷Sao Paulo, Brazil
The Ottawa Hospital /ID# 200682
🇨🇦Ottawa, Ontario, Canada
Tom Baker Cancer Centre /ID# 171561
🇨🇦Calgary, Alberta, Canada
London Health Sciences Centre /ID# 171567
🇨🇦London, Ontario, Canada
Franziskus-Hospital Harderberg /ID# 201145
🇩🇪Georgsmarienhütte, Niedersachsen, Germany
Asklepios Fachkliniken M. Gaut /ID# 170081
🇩🇪Gauting, Germany
Klinikum Kassel - Onkologie /ID# 170083
🇩🇪Kassel, Germany
Pius Hospital Oldenburg /ID# 170080
🇩🇪Oldenburg, Germany
Universitatsklinikum Munster /ID# 170087
🇩🇪Muenster, Germany
Gavle Hospital /ID# 171253
🇸🇪Gavle, Sweden
Akademiska Sjukhuset /ID# 171248
🇸🇪Uppsala, Uppsala Lan, Sweden
University Hospital Linkoping /ID# 201666
🇸🇪Linkoping, Sweden
Karolinska University Hospital /ID# 201967
🇸🇪Stockholm, Sweden
Norrlands Universitetssjukhus /ID# 171250
🇸🇪Umeå, Sweden
Christie NHS Foundation Trust /ID# 201149
🇬🇧Manchester, United Kingdom
Royal Preston Hospital /ID# 201146
🇬🇧Preston, United Kingdom
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- Walnut Creek /ID# 201305
🇺🇸Walnut Creek, California, United States
Kaiser Permanente Medical Ctr-Vallejo /ID# 169758
🇺🇸Vallejo, California, United States
Baptist Health /ID# 171379
🇺🇸Lexington, Kentucky, United States
St. Luke's Hematology Oncology /ID# 171378
🇺🇸Bethlehem, Pennsylvania, United States
Kadlec Clinic Hematology and O /ID# 169797
🇺🇸Kennewick, Washington, United States
Univ of Colorado Cancer Center /ID# 200810
🇺🇸Aurora, Colorado, United States
Perron Institute for Neurological and Translational Science /ID# 200644
🇦🇺Nedlands, Western Australia, Australia
Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 200496
🇧🇷Ijuí, Rio Grande Do Sul, Brazil
Mount Sinai Comp Cancer Ctr /ID# 169759
🇺🇸Miami, Florida, United States
Tennessee Oncology PLLC: Sarah /ID# 171380
🇺🇸Nashville, Tennessee, United States
Vanderbilt Ingram Henry Cancer /ID# 171356
🇺🇸Nashville, Tennessee, United States
Charite Universitatsmedizin B- /ID# 170079
🇩🇪Berlin, Germany
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
QE II Health Sciences Centre /ID# 171569
🇨🇦Halifax, Nova Scotia, Canada
Austin Hospital /ID# 200639
🇦🇺Heidelberg, Victoria, Australia
Thoraxklinik Heidelberg gGmbH /ID# 170078
🇩🇪Heidelberg, Germany
Border Medical /ID# 200645
🇦🇺Wodonga, Victoria, Australia
Leicester Royal Infirmary /ID# 201154
🇬🇧Leicester, England, United Kingdom
Mayo Clinic - Scottsdale /ID# 171359
🇺🇸Scottsdale, Arizona, United States
Tulane Cancer Center Clinic /ID# 171376
🇺🇸New Orleans, Louisiana, United States