Back to resultsStudy Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dexamethasone
Rovalpituzumab tesirine
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring 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
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.
Sites / Locations
- Ironwood Cancer & Res Ctr /ID# 171335
- Mayo Clinic - Scottsdale /ID# 171359
- VA Central California Health C /ID# 170951
- Loma Linda University Medical /ID# 171377
- UC Irvine Health /ID# 171343
- Kaiser Permanente - Roseville /ID# 200779
- Kaiser Permanente-Santa Clara /ID# 203024
- Kaiser Permanente Medical Ctr-Vallejo /ID# 169758
- Kaiser Permanente- Walnut Creek /ID# 201305
- Univ of Colorado Cancer Center /ID# 200810
- Boca Raton Regional Hospital /ID# 200168
- UMHC/Sylvester Comprehensive /ID# 171462
- Mount Sinai Comp Cancer Ctr /ID# 169759
- Illinois Cancer Care, PC /ID# 171310
- Baptist Health /ID# 171379
- Norton Cancer Institute /ID# 200827
- Tulane Cancer Center Clinic /ID# 171376
- Sandra Malcolm Berman Cncr Ins /ID# 171346
- St. Luke's University Hospital /ID# 171374
- Valley Hospital - Westwood, NJ /ID# 171357
- Wake Forest Baptist Medical Center /ID# 169799
- The Ohio State University Comp /ID# 171352
- St. Luke's Hematology Oncology /ID# 171378
- Tennessee Oncology PLLC: Sarah /ID# 171380
- Vanderbilt Ingram Henry Cancer /ID# 171356
- VCS, Virginia Cancer Specialis /ID# 169760
- Kadlec Clinic Hematology and O /ID# 169797
- Coffs Harbour Health Campus /ID# 200642
- The Tweed Hospital /ID# 200646
- The Townsville Hospital /ID# 200640
- Austin Hospital /ID# 200639
- Border Medical /ID# 200645
- Perron Institute for Neurological and Translational Science /ID# 200644
- Bahia Oncology Center - NOB /ID# 201272
- Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 200496
- Hospital Sao Lucas da PUCRS /ID# 201258
- Icesp /Id# 201036
- Inca /Id# 202594
- Instituto COI de Educacao e Pe /ID# 200499
- Fundacao Antonio Prudente /ID# 200218
- Hospital de Cancer de Barretos /ID# 200104
- Tom Baker Cancer Centre /ID# 171561
- QE II Health Sciences Centre /ID# 171569
- London Health Sciences Centre /ID# 171567
- The Ottawa Hospital /ID# 200682
- Franziskus-Hospital Harderberg /ID# 201145
- Charite Universitatsmedizin B- /ID# 170079
- Asklepios Fachkliniken M. Gaut /ID# 170081
- Thoraxklinik Heidelberg gGmbH /ID# 170078
- Klinikum Kassel - Onkologie /ID# 170083
- Universitatsklinikum Munster /ID# 170087
- Pius Hospital Oldenburg /ID# 170080
- Akademiska Sjukhuset /ID# 171248
- Gavle Hospital /ID# 171253
- University Hospital Linkoping /ID# 201666
- Karolinska University Hospital /ID# 201967
- Norrlands Universitetssjukhus /ID# 171250
- Leicester Royal Infirmary /ID# 201154
- Christie NHS Foundation Trust /ID# 201149
- Royal Preston Hospital /ID# 201146
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rovalpituzumab tesirine + dexamethasone
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE
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
Change in Participant Reported Outcome EORTC QLQC15-PAL
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)
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.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.
Objective response rate (ORR)
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.
Change in EORTC QLQ-LC-13
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.
Duration of Objective Response (DOR)
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.
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD) according to RECIST version 1.1.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03334487
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 Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Strategic considerations
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rovalpituzumab tesirine + dexamethasone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Rovalpituzumab tesirine
Other Intervention Name(s)
SC16LD6.5
Intervention Description
Intravenous
Primary Outcome Measure Information:
Title
Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE
Description
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.
Time Frame
Approximately 32 months
Secondary Outcome Measure Information:
Title
Change in Participant Reported Outcome EORTC QLQC15-PAL
Description
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).
Time Frame
Approximately 32 months
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Approximately 32 months
Title
Overall Survival (OS)
Description
Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.
Time Frame
Approximately 32 months
Title
Objective response rate (ORR)
Description
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.
Time Frame
Approximately 32 months
Title
Change in EORTC QLQ-LC-13
Description
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.
Time Frame
Approximately 32 months
Title
Duration of Objective Response (DOR)
Description
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.
Time Frame
Approximately 32 months
Title
Clinical Benefit Rate (CBR)
Description
CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD) according to RECIST version 1.1.
Time Frame
Approximately 32 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Cancer & Res Ctr /ID# 171335
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224-5665
Country
United States
Facility Name
Mayo Clinic - Scottsdale /ID# 171359
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
VA Central California Health C /ID# 170951
City
Fresno
State/Province
California
ZIP/Postal Code
93703
Country
United States
Facility Name
Loma Linda University Medical /ID# 171377
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
UC Irvine Health /ID# 171343
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Facility Name
Kaiser Permanente - Roseville /ID# 200779
City
Roseville
State/Province
California
ZIP/Postal Code
95661-3027
Country
United States
Facility Name
Kaiser Permanente-Santa Clara /ID# 203024
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051-5173
Country
United States
Facility Name
Kaiser Permanente Medical Ctr-Vallejo /ID# 169758
City
Vallejo
State/Province
California
ZIP/Postal Code
94589-2441
Country
United States
Facility Name
Kaiser Permanente- Walnut Creek /ID# 201305
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Univ of Colorado Cancer Center /ID# 200810
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Boca Raton Regional Hospital /ID# 200168
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
UMHC/Sylvester Comprehensive /ID# 171462
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Facility Name
Mount Sinai Comp Cancer Ctr /ID# 169759
City
Miami
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Illinois Cancer Care, PC /ID# 171310
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Baptist Health /ID# 171379
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503-1463
Country
United States
Facility Name
Norton Cancer Institute /ID# 200827
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-3700
Country
United States
Facility Name
Tulane Cancer Center Clinic /ID# 171376
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Sandra Malcolm Berman Cncr Ins /ID# 171346
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
St. Luke's University Hospital /ID# 171374
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55802
Country
United States
Facility Name
Valley Hospital - Westwood, NJ /ID# 171357
City
Westwood
State/Province
New Jersey
ZIP/Postal Code
07675
Country
United States
Facility Name
Wake Forest Baptist Medical Center /ID# 169799
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Facility Name
The Ohio State University Comp /ID# 171352
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
St. Luke's Hematology Oncology /ID# 171378
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Tennessee Oncology PLLC: Sarah /ID# 171380
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt Ingram Henry Cancer /ID# 171356
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
VCS, Virginia Cancer Specialis /ID# 169760
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Kadlec Clinic Hematology and O /ID# 169797
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Coffs Harbour Health Campus /ID# 200642
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
The Tweed Hospital /ID# 200646
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
The Townsville Hospital /ID# 200640
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Austin Hospital /ID# 200639
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Border Medical /ID# 200645
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Perron Institute for Neurological and Translational Science /ID# 200644
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Bahia Oncology Center - NOB /ID# 201272
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40170-110
Country
Brazil
Facility Name
Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 200496
City
Ijuí
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS /ID# 201258
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Icesp /Id# 201036
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Inca /Id# 202594
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Instituto COI de Educacao e Pe /ID# 200499
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Fundacao Antonio Prudente /ID# 200218
City
Sao Paulo
ZIP/Postal Code
01509-000
Country
Brazil
Facility Name
Hospital de Cancer de Barretos /ID# 200104
City
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Tom Baker Cancer Centre /ID# 171561
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
QE II Health Sciences Centre /ID# 171569
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
London Health Sciences Centre /ID# 171567
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
The Ottawa Hospital /ID# 200682
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Franziskus-Hospital Harderberg /ID# 201145
City
Georgsmarienhütte
State/Province
Niedersachsen
ZIP/Postal Code
49124
Country
Germany
Facility Name
Charite Universitatsmedizin B- /ID# 170079
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Asklepios Fachkliniken M. Gaut /ID# 170081
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Thoraxklinik Heidelberg gGmbH /ID# 170078
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Klinikum Kassel - Onkologie /ID# 170083
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Universitatsklinikum Munster /ID# 170087
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Pius Hospital Oldenburg /ID# 170080
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Akademiska Sjukhuset /ID# 171248
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Gavle Hospital /ID# 171253
City
Gavle
ZIP/Postal Code
801 88
Country
Sweden
Facility Name
University Hospital Linkoping /ID# 201666
City
Linkoping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Karolinska University Hospital /ID# 201967
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden
Facility Name
Norrlands Universitetssjukhus /ID# 171250
City
Umeå
ZIP/Postal Code
90185
Country
Sweden
Facility Name
Leicester Royal Infirmary /ID# 201154
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Christie NHS Foundation Trust /ID# 201149
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Preston Hospital /ID# 201146
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Learn more about this trial
Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
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