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)
Small Cell Lung Cancer
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
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
Experimental
Active Comparator
Rovalpituzumab tesirine
Topotecan
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.