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Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE) (TAHOE)

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rovalpituzumab tesirine
Topotecan
Dexamethasone
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small cell lung cancer (SCLC), Delta-like protein 3 (DLL3), rovalpituzumab tesirine, topotecan, metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant must have histologically or cytologically confirmed advanced or metastatic Small Cell Lung Cancer (SCLC) with documented first disease progression during or following front-line platinum-based systemic regimen
  • Tumor must have high Delta-like protein 3 (DLL3) expression defined as having ≥ 75% tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay.
  • Participant must have measurable disease, as defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Participant must have recovery to Grade 0 or 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration.

Exclusion Criteria:

  • Participant has a 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 (NYHA) III - IV within 6 months prior to their first dose of study drug.
  • Participant has known leptomeningeal metastases.
  • Participant has received more than one prior systemic therapy regimen for SCLC.
  • Participant had a serious infection within 2 weeks prior to randomization, including any Grade 3 or higher viral, bacterial, or fungal infection.
  • Participant has a history of active malignancies other than SCLC within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated.
  • Participant had prior exposure to topotecan, irinotecan or any other topoisomerase I inhibitors.

Sites / Locations

  • Clearview Cancer Institute /ID# 155873
  • Mitchell Cancer Institute /ID# 158151
  • Carti /Id# 156982
  • Highlands Oncology Group /ID# 155902
  • Cedars-Sinai Medical Center /ID# 157102
  • Moore UC San Diego Cancer Center /ID# 156965
  • Los Angeles Hematology Oncolog /ID# 155879
  • University of California, Davis Comprehensive Cancer Center /ID# 157001
  • St Jude Hospital dba St Joseph /ID# 155899
  • Icri /Id# 157090
  • Christiana Care Health Service /ID# 158171
  • Cancer Specialists of North Florida - Southpoint /ID# 155828
  • Georgia Cancer Center /ID# 160206
  • St. Luke's Mountain States Tumor Institute - Meridian /ID# 164550
  • NorthShore University HealthSystem - Evanston Hospital /ID# 157054
  • Ingalls Memorial Hosp /ID# 155871
  • Goshen Center for Cancer Care /ID# 155946
  • University of Louisville /ID# 155947
  • Ochsner Clinic Foundation /ID# 160807
  • Dana-Farber Cancer Institute /ID# 160210
  • Sparrow Regional Cancer Center, Sparrow Health System /ID# 157021
  • Nebraska Hematology Oncology /ID# 155900
  • Gabrail Cancer Center Research /ID# 155920
  • Oregon Health and Science University /ID# 157055
  • UPMC Hillman Cancer Ctr /ID# 164403
  • Univ Medical Ctr Brackenridge /ID# 156967
  • UT Southwestern Medical Center /ID# 158150
  • University of Vermont Medical Center /ID# 162317
  • University of Washington /ID# 162626
  • Medical Oncology Associates /ID# 156856
  • West Virginia Univ School Med /ID# 155872
  • Blacktown Hospital /ID# 158907
  • St George Hospital /ID# 158855
  • Southern Medical Day Care Ctr /ID# 158853
  • The Prince Charles Hospital /ID# 158897
  • Ballarat Health Service /ID# 158904
  • Austin Hospital /ID# 158898
  • Bobruysk Interdistrict Onco. /ID# 169394
  • State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159325
  • Mogilev Reg. Oncologic dispe /ID# 159326
  • CHU Saint-Pierre /ID# 159521
  • Grand Hôpital de Charleroi /ID# 158748
  • Cliniques universitaires Saint /ID# 158751
  • Hopital de Jolimont /ID# 159755
  • UZ Leuven /ID# 158752
  • CHU de Liege Sart Tilman /ID# 158753
  • CHU Charleroi (Vesale) /ID# 159756
  • Liga Norte Rio Grandense Cont. /ID# 159015
  • Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159668
  • Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159017
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666
  • Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159665
  • UMHAT Tsaritsa Joanna - ISUL /ID# 159641
  • UMHAT Sv. Ivan Rilski /ID# 159642
  • Cross Cancer Institute /ID# 159519
  • Juravinski Cancer Clinic /ID# 159514
  • Hopital du Sacre Coeur Montreal /ID# 159515
  • CHU de Quebec-Universite Laval /ID# 159093
  • Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 208931
  • Jilin Cancer Hosptial /ID# 204059
  • Klinicki bolnicki centar Sestre milosrdnice /ID# 158811
  • Klinika za plucne bolesti Jordanovac /ID# 159502
  • Klinicki bolnicki centar Rijeka /ID# 159501
  • Thomayerova nemocnice /ID# 159061
  • Nemocnice Na Plesi s.r.o. /ID# 161190
  • Nemocnice Rudolfa a Stefanie /ID# 159652
  • Nemocnice Horovice a.s. /ID# 161191
  • Krajska nemocnice Liberec a.s. /ID# 159653
  • Herlev Hospital /ID# 158049
  • Odense Universitets Hospital /ID# 158050
  • Rigshospitalet, Finsen Centre /ID# 158051
  • Hopital Haut-Lévêque /ID# 160558
  • Assis.Publique-Hopital Nord /ID# 160554
  • Centre Leon Berard /ID# 160561
  • Centre Hosp Intercommunal de Creteil /ID# 162684
  • Assistance Publique- Hopitaux /ID# 160552
  • Hospital Pontchaillou /ID# 160555
  • KH Martha-Maria Halle Dolau /ID# 158796
  • Evangelische Lungenklinik Berl /ID# 159168
  • Asklepios Fachkliniken M. Gaut /ID# 158791
  • Lungen Clinic Grosshansdorf /ID# 158770
  • Thoraxklinik Heidelberg gGmbH /ID# 159169
  • Klinikum Kassel /ID# 158788
  • Klinik Loewenstein GmbH /ID# 159167
  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159165
  • Metropolitan Hospital /ID# 159162
  • University Hospital of Ioannin /ID# 159163
  • Euromedica General Clinic /ID# 159161
  • Torokbalinti Tudogyogyintezet /ID# 207053
  • Semmelweis Egyetem /ID# 161197
  • Orszagos Koranyi Pulmonologiai Intezet /ID# 158967
  • Dup_Debreceni Egyetem Klinikai Központ /ID# 161209
  • Veszprem Megyei Tuedoegyogyint /ID# 162607
  • Petz Aladar Megyei Oktato Korh /ID# 158978
  • Matrai Gyogyintezet /ID# 158979
  • AUSL 8 Arezzo Ospedale San Don /ID# 160967
  • Istituto Europeo di Oncologia /ID# 158942
  • A.O.U. San Luigi Gonzaga /ID# 158945
  • Ospedale Santa Maria delle Cro /ID# 158940
  • IFO Istituto Nazionale Tumori /ID# 158941
  • Aichi Cancer Center Hospital /ID# 164975
  • National Cancer Center Hospital East /ID# 165726
  • Kyushu University Hospital /ID# 165723
  • Kurume University Hospital /ID# 164586
  • Hokkaido Cancer Center /ID# 165237
  • Hyogo Cancer Center /ID# 165125
  • Himeji Medical Center /ID# 165893
  • Duplicate_Kanazawa University Hospital /ID# 165129
  • Yokohama City University Hospital /ID# 165748
  • Kanagawa Cardiovascular and Respiratory Center /ID# 164374
  • Sendai Kousei Hospital /ID# 166061
  • Japanese Red Cross Okayama Hospital /ID# 165156
  • Kansai Medical University Hospital /ID# 165055
  • Kindai University Hospital /ID# 166394
  • Osaka City General Hospital /ID# 165717
  • Shizuoka Cancer Center /ID# 166466
  • Tokushima University Hospital /ID# 165812
  • National Cancer Center Hospital /ID# 166768
  • The Cancer Institute Hospital Of JFCR /ID# 166249
  • Duplicate_Showa University Hospital /ID# 165574
  • Wakayama Medical University /ID# 166032
  • Matsusaka City Hospital /ID# 166126
  • Kanagawa Cancer Center /ID# 165816
  • Dong-A University Hospital /ID# 159296
  • CHA Bundang Medical center CHA University /ID# 204416
  • Chonnam National University Hospital /ID# 159294
  • Kyungpook National University Chilgok Hospital /ID# 159292
  • Yonsei University Health System, Severance Hospital /ID# 159288
  • Korea University Guro Hospital /ID# 159293
  • Chungbuk National University /ID# 159291
  • Asan Medical Center /ID# 159290
  • Pauls Stradins Clinical /ID# 158713
  • Riga East Clinical University /ID# 158714
  • Centro de Investigación Clinica Chapultepec /ID# 161000
  • Health Pharma Professional Research S.A de C.V /ID# 160020
  • Universitair Medisch Centrum Groningen /ID# 158088
  • Ziekenhuis St. Jansdal /ID# 158652
  • Isala /ID# 158653
  • Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537
  • Copernicus PL Sp. z o. o., WCO /ID# 160538
  • Szpitale Pomorskie Sp. z o.o /ID# 160536
  • Centro Hospitalar Lisboa Norte, EPE /ID# 158687
  • IPO Lisboa FG, EPE /ID# 158995
  • Hospital da Luz, SA /ID# 158996
  • Unidade Local Saude Matosinhos /ID# 158682
  • Hospital CUF Porto /ID# 158685
  • IPO Porto FG, EPE /ID# 158686
  • S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847
  • Oncocenter Oncologie Clinica S /ID# 160848
  • Spitalul Judetean de Urgenta A /ID# 160846
  • National Medical Research Cntr /ID# 207436
  • LLC Novaya Klinika /ID# 205539
  • Arkhangelsk clinical oncology /ID# 159309
  • Kaluga Regional Clinical Oncol /ID# 160179
  • Clinical Onco Dispensary /ID# 159307
  • PMI Euromedservice /ID# 159311
  • Smolensk Regional Onc Clin Dis /ID# 159314
  • LLC BioEq Ltd. /ID# 159310
  • N.N. Petrov Research Inst Onc /ID# 159312
  • Clinical Center of Nis /ID# 160059
  • Institut za onkologiju i radio /ID# 160058
  • Klinicki centar Srbije /ID# 160024
  • Institute For Pulmonary Diseas /ID# 158813
  • National University Hospital /ID# 158802
  • National Cancer Ctr Singapore /ID# 158803
  • Hospital Clinic /ID# 159031
  • Hospital Santa Creu i Sant Pau /ID# 159028
  • Hospital General Universitario Gregorio Maranon /ID# 159025
  • Hospital Universitario HM Sanchinarro /ID# 159024
  • Hospital Clinico Universitario de Valencia /ID# 159027
  • Sahlgrenska US Gbg /ID# 159534
  • Uppsala University Hospital /ID# 159050
  • National Cheng Kung University Hospital /ID# 158844
  • National Taiwan University Hospital /ID# 158865
  • Tri-Service General Hospital /ID# 158985
  • Taichung Veterans General Hosp /ID# 158866
  • Hacettepe University Medical Faculty /ID# 159238
  • Inonu Universitesi Turgut Ozal /ID# 159241
  • Ege University Medical Faculty /ID# 159239
  • Dr. Suat Seren Gogus Has /ID# 159240
  • Ataturk Gogus Hastaliklari ve /ID# 160056
  • CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159122
  • Municipal institution /ID# 159867
  • Municipal institution Multifie /ID# 159121
  • Regional Center of Oncology /ID# 159123
  • PE PMC Acinus, Medical and Diagnostic Center /ID# 159125
  • ME Kryviy Rih Oncology Dispensary /ID# 159119
  • Volyn Regional Medical Oncology Centre /ID# 159124
  • Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159868
  • Guy's and St Thomas' NHS Found /ID# 159581
  • United Lincolnshire Hospitals /ID# 159579
  • Charing Cross Hospital /ID# 159582
  • Christie NHS Foundation Trust /ID# 159099
  • James Cook University Hospital /ID# 159583
  • Royal Preston Hospital /ID# 159578

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rovalpituzumab tesirine

Topotecan

Arm Description

Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted. Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.

Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m^2 on Days 1 to 5 of each 21-day cycle.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause. Participants were censored at the last date they were documented alive. After the End of treatment, survival information was collected at approximately 6-week intervals (or as requested by sponsor to support data analysis) continuing until the endpoint of death, the participant became lost to follow-up, AbbVie terminated the study, or until 12 February 2020. Calculated using the Kaplan-Meier product-limit method.

Secondary Outcome Measures

Progression Free Survival (PFS)
PFS is defined as the number of months from the date of randomization until the date of first progression or the date of a participant's death, whichever occurs first. If a participant neither experienced disease progression nor died, then the participant's data were censored at the last date of radiographic assessment that they were documented to be progression free. Calculated using the Kaplan-Meier product-limit method. Radiographic tumor assessments for response were conducted by CT scanning according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Progressive Disease (PD) was defined as at least a 20% increase in the size of target lesions and an absolute increase of at least 5 mm taking as reference the smallest lesion size recorded since the treatment started (baseline or after), or the appearance of one or more new lesions.
Change From Baseline of the Physical Functioning Scale Score in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) at Week 7
The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The score of 'physical functioning scale' score ranges from 0 (very poor) to 100 (excellent).
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 RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Clinical Benefit Rate (CBR)
CBR is defined as percentage of participants whose best overall response is CR, PR, or stable disease (SD) according to RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR, PR, or SD, including those who did not have post-baseline radiological assessments were considered as experiencing no clinical benefit. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
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. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Full Information

First Posted
February 20, 2017
Last Updated
February 19, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03061812
Brief Title
Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)
Acronym
TAHOE
Official Title
A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for Subjects With Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) Who Have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (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
Yes

5. Study Description

Brief Summary
The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Small cell lung cancer (SCLC), Delta-like protein 3 (DLL3), rovalpituzumab tesirine, topotecan, metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rovalpituzumab tesirine
Arm Type
Experimental
Arm Description
Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted. Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.
Arm Title
Topotecan
Arm Type
Active Comparator
Arm Description
Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m^2 on Days 1 to 5 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Rovalpituzumab tesirine
Other Intervention Name(s)
Rova-T
Intervention Description
Powder for solution for infusion in vials.
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
Powder or solution for infusion in vials. Topotecan is commercially available as both a powder and solution for infusion. Availability will vary by region.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Oral tablet.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death from any cause. Participants were censored at the last date they were documented alive. After the End of treatment, survival information was collected at approximately 6-week intervals (or as requested by sponsor to support data analysis) continuing until the endpoint of death, the participant became lost to follow-up, AbbVie terminated the study, or until 12 February 2020. Calculated using the Kaplan-Meier product-limit method.
Time Frame
From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is defined as the number of months from the date of randomization until the date of first progression or the date of a participant's death, whichever occurs first. If a participant neither experienced disease progression nor died, then the participant's data were censored at the last date of radiographic assessment that they were documented to be progression free. Calculated using the Kaplan-Meier product-limit method. Radiographic tumor assessments for response were conducted by CT scanning according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Progressive Disease (PD) was defined as at least a 20% increase in the size of target lesions and an absolute increase of at least 5 mm taking as reference the smallest lesion size recorded since the treatment started (baseline or after), or the appearance of one or more new lesions.
Time Frame
From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.
Title
Change From Baseline of the Physical Functioning Scale Score in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) at Week 7
Description
The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The score of 'physical functioning scale' score ranges from 0 (very poor) to 100 (excellent).
Time Frame
Baseline, Week 7
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 RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame
Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.
Title
Clinical Benefit Rate (CBR)
Description
CBR is defined as percentage of participants whose best overall response is CR, PR, or stable disease (SD) according to RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR, PR, or SD, including those who did not have post-baseline radiological assessments were considered as experiencing no clinical benefit. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame
Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.
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. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame
Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must have histologically or cytologically confirmed advanced or metastatic Small Cell Lung Cancer (SCLC) with documented first disease progression during or following front-line platinum-based systemic regimen Tumor must have high Delta-like protein 3 (DLL3) expression defined as having ≥ 75% tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay. Participant must have measurable disease, as defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Participant must have recovery to Grade 0 or 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration. Exclusion Criteria: Participant has a 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 (NYHA) III - IV within 6 months prior to their first dose of study drug. Participant has known leptomeningeal metastases. Participant has received more than one prior systemic therapy regimen for SCLC. Participant had a serious infection within 2 weeks prior to randomization, including any Grade 3 or higher viral, bacterial, or fungal infection. Participant has a history of active malignancies other than SCLC within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated. Participant had prior exposure to topotecan, irinotecan or any other topoisomerase I inhibitors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Clearview Cancer Institute /ID# 155873
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Mitchell Cancer Institute /ID# 158151
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Carti /Id# 156982
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Highlands Oncology Group /ID# 155902
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Cedars-Sinai Medical Center /ID# 157102
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Moore UC San Diego Cancer Center /ID# 156965
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Los Angeles Hematology Oncolog /ID# 155879
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
University of California, Davis Comprehensive Cancer Center /ID# 157001
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
St Jude Hospital dba St Joseph /ID# 155899
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Icri /Id# 157090
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Christiana Care Health Service /ID# 158171
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Cancer Specialists of North Florida - Southpoint /ID# 155828
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Georgia Cancer Center /ID# 160206
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
St. Luke's Mountain States Tumor Institute - Meridian /ID# 164550
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
NorthShore University HealthSystem - Evanston Hospital /ID# 157054
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ingalls Memorial Hosp /ID# 155871
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Goshen Center for Cancer Care /ID# 155946
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
University of Louisville /ID# 155947
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Clinic Foundation /ID# 160807
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70836-6455
Country
United States
Facility Name
Dana-Farber Cancer Institute /ID# 160210
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Sparrow Regional Cancer Center, Sparrow Health System /ID# 157021
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Nebraska Hematology Oncology /ID# 155900
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Gabrail Cancer Center Research /ID# 155920
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Oregon Health and Science University /ID# 157055
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
UPMC Hillman Cancer Ctr /ID# 164403
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Univ Medical Ctr Brackenridge /ID# 156967
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
UT Southwestern Medical Center /ID# 158150
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Facility Name
University of Vermont Medical Center /ID# 162317
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-1473
Country
United States
Facility Name
University of Washington /ID# 162626
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical Oncology Associates /ID# 156856
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
West Virginia Univ School Med /ID# 155872
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Blacktown Hospital /ID# 158907
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
St George Hospital /ID# 158855
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Southern Medical Day Care Ctr /ID# 158853
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
The Prince Charles Hospital /ID# 158897
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Ballarat Health Service /ID# 158904
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Austin Hospital /ID# 158898
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Bobruysk Interdistrict Onco. /ID# 169394
City
Bobruisk
ZIP/Postal Code
213825
Country
Belarus
Facility Name
State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159325
City
Lesnoy
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Mogilev Reg. Oncologic dispe /ID# 159326
City
Mogilev
ZIP/Postal Code
212018
Country
Belarus
Facility Name
CHU Saint-Pierre /ID# 159521
City
Bruxelles
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Grand Hôpital de Charleroi /ID# 158748
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Cliniques universitaires Saint /ID# 158751
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Hopital de Jolimont /ID# 159755
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
UZ Leuven /ID# 158752
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liege Sart Tilman /ID# 158753
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Charleroi (Vesale) /ID# 159756
City
Montigny-le-tilleul
ZIP/Postal Code
6110
Country
Belgium
Facility Name
Liga Norte Rio Grandense Cont. /ID# 159015
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159668
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159017
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159665
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
UMHAT Tsaritsa Joanna - ISUL /ID# 159641
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
UMHAT Sv. Ivan Rilski /ID# 159642
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Cross Cancer Institute /ID# 159519
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Juravinski Cancer Clinic /ID# 159514
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Hopital du Sacre Coeur Montreal /ID# 159515
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
CHU de Quebec-Universite Laval /ID# 159093
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 208931
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Jilin Cancer Hosptial /ID# 204059
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
Klinicki bolnicki centar Sestre milosrdnice /ID# 158811
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinika za plucne bolesti Jordanovac /ID# 159502
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Rijeka /ID# 159501
City
Rijeka
State/Province
Primorsko-goranska Zupanija
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Thomayerova nemocnice /ID# 159061
City
Prague
State/Province
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Nemocnice Na Plesi s.r.o. /ID# 161190
City
Nová Ves pod Pleší
State/Province
Pribram
ZIP/Postal Code
262 04
Country
Czechia
Facility Name
Nemocnice Rudolfa a Stefanie /ID# 159652
City
Benesov
ZIP/Postal Code
256 01
Country
Czechia
Facility Name
Nemocnice Horovice a.s. /ID# 161191
City
Horovice
ZIP/Postal Code
268 31
Country
Czechia
Facility Name
Krajska nemocnice Liberec a.s. /ID# 159653
City
Liberec
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Herlev Hospital /ID# 158049
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Odense Universitets Hospital /ID# 158050
City
Odense C
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Rigshospitalet, Finsen Centre /ID# 158051
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Hopital Haut-Lévêque /ID# 160558
City
Pessac CEDEX
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
Assis.Publique-Hopital Nord /ID# 160554
City
Marseille
State/Province
Provence-Alpes-Cote-d Azur
ZIP/Postal Code
13105
Country
France
Facility Name
Centre Leon Berard /ID# 160561
City
Lyon CEDEX 08
State/Province
Rhone
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Hosp Intercommunal de Creteil /ID# 162684
City
Creteil
State/Province
Val-de-Marne
ZIP/Postal Code
94000
Country
France
Facility Name
Assistance Publique- Hopitaux /ID# 160552
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hospital Pontchaillou /ID# 160555
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
KH Martha-Maria Halle Dolau /ID# 158796
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Evangelische Lungenklinik Berl /ID# 159168
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Asklepios Fachkliniken M. Gaut /ID# 158791
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Lungen Clinic Grosshansdorf /ID# 158770
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Thoraxklinik Heidelberg gGmbH /ID# 159169
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Klinikum Kassel /ID# 158788
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Klinik Loewenstein GmbH /ID# 159167
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159165
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Metropolitan Hospital /ID# 159162
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
University Hospital of Ioannin /ID# 159163
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Euromedica General Clinic /ID# 159161
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Torokbalinti Tudogyogyintezet /ID# 207053
City
Budapest
State/Province
Pest
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 161197
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Orszagos Koranyi Pulmonologiai Intezet /ID# 158967
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Dup_Debreceni Egyetem Klinikai Központ /ID# 161209
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Veszprem Megyei Tuedoegyogyint /ID# 162607
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korh /ID# 158978
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Matrai Gyogyintezet /ID# 158979
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
AUSL 8 Arezzo Ospedale San Don /ID# 160967
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Istituto Europeo di Oncologia /ID# 158942
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
A.O.U. San Luigi Gonzaga /ID# 158945
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Ospedale Santa Maria delle Cro /ID# 158940
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
IFO Istituto Nazionale Tumori /ID# 158941
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Aichi Cancer Center Hospital /ID# 164975
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East /ID# 165726
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Kyushu University Hospital /ID# 165723
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kurume University Hospital /ID# 164586
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hokkaido Cancer Center /ID# 165237
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hyogo Cancer Center /ID# 165125
City
Akashi-shi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Himeji Medical Center /ID# 165893
City
Himeji-shi
State/Province
Hyogo
ZIP/Postal Code
670-0012
Country
Japan
Facility Name
Duplicate_Kanazawa University Hospital /ID# 165129
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Yokohama City University Hospital /ID# 165748
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center /ID# 164374
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Sendai Kousei Hospital /ID# 166061
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Japanese Red Cross Okayama Hospital /ID# 165156
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8607
Country
Japan
Facility Name
Kansai Medical University Hospital /ID# 165055
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Kindai University Hospital /ID# 166394
City
Osaka-sayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka City General Hospital /ID# 165717
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Shizuoka Cancer Center /ID# 166466
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tokushima University Hospital /ID# 165812
City
Tokushima-shi
State/Province
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
National Cancer Center Hospital /ID# 166768
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital Of JFCR /ID# 166249
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Duplicate_Showa University Hospital /ID# 165574
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-0054
Country
Japan
Facility Name
Wakayama Medical University /ID# 166032
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Matsusaka City Hospital /ID# 166126
City
Matsusaka-shi MIE
ZIP/Postal Code
515-8544
Country
Japan
Facility Name
Kanagawa Cancer Center /ID# 165816
City
Yokohama
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Dong-A University Hospital /ID# 159296
City
Busan
State/Province
Busan Gwang Yeogsi
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
CHA Bundang Medical center CHA University /ID# 204416
City
Seongnam si
State/Province
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital /ID# 159294
City
Gwangju
State/Province
Jeonranamdo
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital /ID# 159292
City
Daegu
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Yonsei University Health System, Severance Hospital /ID# 159288
City
Seodaemun-gu
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital /ID# 159293
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Chungbuk National University /ID# 159291
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 159290
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Pauls Stradins Clinical /ID# 158713
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Riga East Clinical University /ID# 158714
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Centro de Investigación Clinica Chapultepec /ID# 161000
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58260
Country
Mexico
Facility Name
Health Pharma Professional Research S.A de C.V /ID# 160020
City
Del. Benito Juárez
ZIP/Postal Code
03810
Country
Mexico
Facility Name
Universitair Medisch Centrum Groningen /ID# 158088
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Ziekenhuis St. Jansdal /ID# 158652
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
Isala /ID# 158653
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537
City
Rzeszów
State/Province
Podkarpackie
ZIP/Postal Code
35-021
Country
Poland
Facility Name
Copernicus PL Sp. z o. o., WCO /ID# 160538
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o /ID# 160536
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Centro Hospitalar Lisboa Norte, EPE /ID# 158687
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
IPO Lisboa FG, EPE /ID# 158995
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Hospital da Luz, SA /ID# 158996
City
Lisbon
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Unidade Local Saude Matosinhos /ID# 158682
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Hospital CUF Porto /ID# 158685
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Facility Name
IPO Porto FG, EPE /ID# 158686
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200347
Country
Romania
Facility Name
Oncocenter Oncologie Clinica S /ID# 160848
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300166
Country
Romania
Facility Name
Spitalul Judetean de Urgenta A /ID# 160846
City
Alba
ZIP/Postal Code
510077
Country
Romania
Facility Name
National Medical Research Cntr /ID# 207436
City
Moscow
State/Province
Moskovskaya Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
LLC Novaya Klinika /ID# 205539
City
Pyatigorsk
State/Province
Stavropol Skiy Kray
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Arkhangelsk clinical oncology /ID# 159309
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Kaluga Regional Clinical Oncol /ID# 160179
City
Kaluga
ZIP/Postal Code
284007
Country
Russian Federation
Facility Name
Clinical Onco Dispensary /ID# 159307
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
PMI Euromedservice /ID# 159311
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Smolensk Regional Onc Clin Dis /ID# 159314
City
Smolensk
ZIP/Postal Code
214009
Country
Russian Federation
Facility Name
LLC BioEq Ltd. /ID# 159310
City
St. Petersburg
ZIP/Postal Code
197342
Country
Russian Federation
Facility Name
N.N. Petrov Research Inst Onc /ID# 159312
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Clinical Center of Nis /ID# 160059
City
NIS
State/Province
Nisavski Okrug
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Institut za onkologiju i radio /ID# 160058
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Klinicki centar Srbije /ID# 160024
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute For Pulmonary Diseas /ID# 158813
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
National University Hospital /ID# 158802
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Cancer Ctr Singapore /ID# 158803
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Hospital Clinic /ID# 159031
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 159028
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 159025
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro /ID# 159024
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia /ID# 159027
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Sahlgrenska US Gbg /ID# 159534
City
Göteborg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 46
Country
Sweden
Facility Name
Uppsala University Hospital /ID# 159050
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
National Cheng Kung University Hospital /ID# 158844
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 158865
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Tri-Service General Hospital /ID# 158985
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Taichung Veterans General Hosp /ID# 158866
City
Taichung City
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Hacettepe University Medical Faculty /ID# 159238
City
Altindağ
State/Province
Ankara
ZIP/Postal Code
06250
Country
Turkey
Facility Name
Inonu Universitesi Turgut Ozal /ID# 159241
City
Battalgazi/malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Ege University Medical Faculty /ID# 159239
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Dr. Suat Seren Gogus Has /ID# 159240
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Ataturk Gogus Hastaliklari ve /ID# 160056
City
Kecioren/ankara
ZIP/Postal Code
06280
Country
Turkey
Facility Name
CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159122
City
Zaporizhzhia
State/Province
Zaporizka Oblast
ZIP/Postal Code
69040
Country
Ukraine
Facility Name
Municipal institution /ID# 159867
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Municipal institution Multifie /ID# 159121
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Regional Center of Oncology /ID# 159123
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
PE PMC Acinus, Medical and Diagnostic Center /ID# 159125
City
Kropyvnytskyi
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
ME Kryviy Rih Oncology Dispensary /ID# 159119
City
Kryviy RIH
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Volyn Regional Medical Oncology Centre /ID# 159124
City
Lutsk
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159868
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Guy's and St Thomas' NHS Found /ID# 159581
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
United Lincolnshire Hospitals /ID# 159579
City
Boston
ZIP/Postal Code
PE21 9QS
Country
United Kingdom
Facility Name
Charing Cross Hospital /ID# 159582
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Christie NHS Foundation Trust /ID# 159099
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
James Cook University Hospital /ID# 159583
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Royal Preston Hospital /ID# 159578
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
Citations:
PubMed Identifier
31506387
Citation
Morgensztern D, Besse B, Greillier L, Santana-Davila R, Ready N, Hann CL, Glisson BS, Farago AF, Dowlati A, Rudin CM, Le Moulec S, Lally S, Yalamanchili S, Wolf J, Govindan R, Carbone DP. Efficacy and Safety of Rovalpituzumab Tesirine in Third-Line and Beyond Patients with DLL3-Expressing, Relapsed/Refractory Small-Cell Lung Cancer: Results From the Phase II TRINITY Study. Clin Cancer Res. 2019 Dec 1;25(23):6958-6966. doi: 10.1158/1078-0432.CCR-19-1133. Epub 2019 Sep 10.
Results Reference
background
PubMed Identifier
29290251
Citation
Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22.
Results Reference
derived

Learn more about this trial

Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)

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