AzTrials
AzTrials

Small Cell Lung CancerPhase 3TAHOENCT03061812

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)

A Phase 3 study testing Rovalpituzumab tesirine, Topotecan and Dexamethasone in people with Small Cell Lung Cancer, run by AbbVie at 195 sites in 33 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Rovalpituzumab tesirine, Topotecan and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
444 participants
Where
195 sitesin 33 countries
Study dates
11 Apr 2017to 12 Feb 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

195 sites in 33 countries.

195 sites in 33 countries

United States31 sites

  • Georgia Cancer Center /ID# 160206

    Atlanta, Georgia, 30342

  • Univ Medical Ctr Brackenridge /ID# 156967

    Austin, Texas, 78701

  • Ochsner Clinic Foundation /ID# 160807

    Baton Rouge, Louisiana, 70836-6455

  • Cedars-Sinai Medical Center /ID# 157102

    Beverly Hills, California, 90211

  • Dana-Farber Cancer Institute /ID# 160210

    Boston, Massachusetts, 02215

  • University of Vermont Medical Center /ID# 162317

    Burlington, Vermont, 05401-1473

  • Gabrail Cancer Center Research /ID# 155920

    Canton, Ohio, 44718

  • UT Southwestern Medical Center /ID# 158150

    Dallas, Texas, 75390-7208

  • NorthShore University HealthSystem - Evanston Hospital /ID# 157054

    Evanston, Illinois, 60201

  • Goshen Center for Cancer Care /ID# 155946

    Goshen, Indiana, 46526

  • Ingalls Memorial Hosp /ID# 155871

    Harvey, Illinois, 60426

  • Clearview Cancer Institute /ID# 155873

    Huntsville, Alabama, 35805

  • Cancer Specialists of North Florida - Southpoint /ID# 155828

    Jacksonville, Florida, 32256

  • Moore UC San Diego Cancer Center /ID# 156965

    La Jolla, California, 92093

  • Sparrow Regional Cancer Center, Sparrow Health System /ID# 157021

    Lansing, Michigan, 48912

  • Nebraska Hematology Oncology /ID# 155900

    Lincoln, Nebraska, 68506

  • Carti /Id# 156982

    Little Rock, Arkansas, 72205

  • Los Angeles Hematology Oncolog /ID# 155879

    Los Angeles, California, 90017

  • University of Louisville /ID# 155947

    Louisville, Kentucky, 40202

  • St. Luke's Mountain States Tumor Institute - Meridian /ID# 164550

    Meridian, Idaho, 83712

  • Mitchell Cancer Institute /ID# 158151

    Mobile, Alabama, 36604

  • West Virginia Univ School Med /ID# 155872

    Morgantown, West Virginia, 26506

  • Christiana Care Health Service /ID# 158171

    Newark, Delaware, 19713

  • UPMC Hillman Cancer Ctr /ID# 164403

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University /ID# 157055

    Portland, Oregon, 97239

  • University of California, Davis Comprehensive Cancer Center /ID# 157001

    Sacramento, California, 95817

  • St Jude Hospital dba St Joseph /ID# 155899

    Santa Rosa, California, 95403

  • University of Washington /ID# 162626

    Seattle, Washington, 98109

  • Medical Oncology Associates /ID# 156856

    Spokane, Washington, 99208

  • Highlands Oncology Group /ID# 155902

    Springdale, Arkansas, 72762

  • Icri /Id# 157090

    Whittier, California, 90603

Other trials in United States

Japan23 sites

  • Hyogo Cancer Center /ID# 165125

    Akashi-shi, Hyōgo, 673-8558

  • National Cancer Center Hospital /ID# 166768

    Chuo-ku, Tokyo, 104-0045

  • Kyushu University Hospital /ID# 165723

    Fukuoka, Fukuoka, 812-8582

  • Himeji Medical Center /ID# 165893

    Himeji-shi, Hyōgo, 670-0012

  • Kansai Medical University Hospital /ID# 165055

    Hirakata-shi, Osaka, 573-1191

  • Duplicate_Kanazawa University Hospital /ID# 165129

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East /ID# 165726

    Kashiwa-shi, Chiba, 277-8577

  • The Cancer Institute Hospital Of JFCR /ID# 166249

    Koto-ku, Tokyo, 135-8550

  • Kurume University Hospital /ID# 164586

    Kurume-shi, Fukuoka, 830-0011

  • Matsusaka City Hospital /ID# 166126

    Matsusaka-shi MIE, 515-8544

  • Aichi Cancer Center Hospital /ID# 164975

    Nagoya, Aichi-ken, 464-8681

  • Japanese Red Cross Okayama Hospital /ID# 165156

    Okayama, Okayama-ken, 700-8607

  • Osaka City General Hospital /ID# 165717

    Osaka, Osaka, 534-0021

  • Kindai University Hospital /ID# 166394

    Osaka-sayama-shi, Osaka, 589-8511

  • Hokkaido Cancer Center /ID# 165237

    Sapporo, Hokkaido, 003-0804

  • Sendai Kousei Hospital /ID# 166061

    Sendai, Miyagi, 980-0873

  • Duplicate_Showa University Hospital /ID# 165574

    Shinagawa-ku, Tokyo, 142-0054

  • Shizuoka Cancer Center /ID# 166466

    Sunto-gun, Shizuoka, 411-8777

  • Tokushima University Hospital /ID# 165812

    Tokushima, Tokushima, 770-8503

  • Wakayama Medical University /ID# 166032

    Wakayama, Wakayama, 641-8510

  • Yokohama City University Hospital /ID# 165748

    Yokohama, Kanagawa, 236-0004

  • Kanagawa Cardiovascular and Respiratory Center /ID# 164374

    Yokohama, Kanagawa, 236-0051

  • Kanagawa Cancer Center /ID# 165816

    Yokohama, 241-0815

Other trials in Japan

Russia9 sites

  • Arkhangelsk clinical oncology /ID# 159309

    Arkhangelsk, 163045

  • Kaluga Regional Clinical Oncol /ID# 160179

    Kaluga, 284007

  • National Medical Research Cntr /ID# 207436

    Moscow, Moscow Oblast, 115478

  • Clinical Onco Dispensary /ID# 159307

    Omsk, 644013

  • PMI Euromedservice /ID# 159311

    Pushkin, 196603

  • LLC Novaya Klinika /ID# 205539

    Pyatigorsk, Stavropol Kray, 357500

  • LLC BioEq Ltd. /ID# 159310

    Saint Petersburg, 197342

  • N.N. Petrov Research Inst Onc /ID# 159312

    Saint Petersburg, 197758

  • Smolensk Regional Onc Clin Dis /ID# 159314

    Smolensk, 214009

Other trials in Russia

South Korea8 sites

  • Dong-A University Hospital /ID# 159296

    Busan, Busan Gwang Yeogsi, 49201

  • Chungbuk National University /ID# 159291

    Cheongju-si, 28644

  • Kyungpook National University Chilgok Hospital /ID# 159292

    Daegu, Seoul Teugbyeolsi, 41404

  • Chonnam National University Hospital /ID# 159294

    Gwangju, Jeonranamdo, 61469

  • Yonsei University Health System, Severance Hospital /ID# 159288

    Seodaemun-gu, Seoul Teugbyeolsi, 03722

  • CHA Bundang Medical center CHA University /ID# 204416

    Seongnam-si, Gyeonggido, 13496

  • Korea University Guro Hospital /ID# 159293

    Seoul, Seoul Teugbyeolsi, 08308

  • Asan Medical Center /ID# 159290

    Seoul, 05505

Other trials in South Korea

Ukraine8 sites

  • Municipal institution /ID# 159867

    Chernivtsi, 58013

  • Municipal institution Multifie /ID# 159121

    Dnipro, 49102

  • Regional Center of Oncology /ID# 159123

    Kharkiv, 61070

  • PE PMC Acinus, Medical and Diagnostic Center /ID# 159125

    Kropyvnytskyi, 25006

  • ME Kryviy Rih Oncology Dispensary /ID# 159119

    Kryviy RIH, 50048

  • Volyn Regional Medical Oncology Centre /ID# 159124

    Lutsk, 43018

  • Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159868

    Uzhhorod, 88000

  • CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159122

    Zaporizhzhya, Zaporizhzhia Oblast, 69040

Other trials in Ukraine

Belgium7 sites

  • CHU Saint-Pierre /ID# 159521

    Brussels, Brussels Capital, 1000

  • Cliniques universitaires Saint /ID# 158751

    Brussels, 1200

  • Grand Hôpital de Charleroi /ID# 158748

    Charleroi, Hainaut, 6000

  • Hopital de Jolimont /ID# 159755

    Haine-Saint-Paul, 7100

  • UZ Leuven /ID# 158752

    Leuven, 3000

  • CHU de Liege Sart Tilman /ID# 158753

    Liège, 4000

  • CHU Charleroi (Vesale) /ID# 159756

    Montigny-le-Tilleul, 6110

Other trials in Belgium

Germany7 sites

  • Evangelische Lungenklinik Berl /ID# 159168

    Berlin, 13125

  • Asklepios Fachkliniken M. Gaut /ID# 158791

    Gauting, 82131

  • Lungen Clinic Grosshansdorf /ID# 158770

    Großhansdorf, 22927

  • KH Martha-Maria Halle Dolau /ID# 158796

    Halle, Saxony-Anhalt, 06120

  • Thoraxklinik Heidelberg gGmbH /ID# 159169

    Heidelberg, 69126

  • Klinikum Kassel /ID# 158788

    Kassel, 34125

  • Klinik Loewenstein GmbH /ID# 159167

    Löwenstein, 74245

Other trials in Germany

Hungary7 sites

  • Torokbalinti Tudogyogyintezet /ID# 207053

    Budapest, Pest County, 2045

  • Semmelweis Egyetem /ID# 161197

    Budapest, 1085

  • Orszagos Koranyi Pulmonologiai Intezet /ID# 158967

    Budapest, 1122

  • Dup_Debreceni Egyetem Klinikai Központ /ID# 161209

    Debrecen, 4032

  • Veszprem Megyei Tuedoegyogyint /ID# 162607

    Farkasgyepű, 8582

  • Petz Aladar Megyei Oktato Korh /ID# 158978

    Győr, 9023

  • Matrai Gyogyintezet /ID# 158979

    Mátraháza, 3233

Other trials in Hungary

Australia6 sites

  • Ballarat Health Service /ID# 158904

    Ballarat, Victoria, 3350

  • Blacktown Hospital /ID# 158907

    Blacktown, New South Wales, 2148

  • The Prince Charles Hospital /ID# 158897

    Chermside, Queensland, 4032

  • Austin Hospital /ID# 158898

    Heidelberg, Victoria, 3084

  • St George Hospital /ID# 158855

    Kogarah, New South Wales, 2217

  • Southern Medical Day Care Ctr /ID# 158853

    Wollongong, New South Wales, 2500

Other trials in Australia

France6 sites

  • Centre Hosp Intercommunal de Creteil /ID# 162684

    Créteil, Val-de-Marne, 94000

  • Centre Leon Berard /ID# 160561

    Lyon, Rhone, 69373

  • Assis.Publique-Hopital Nord /ID# 160554

    Marseille, Provence-Alpes-Côte d'Azur Region, 13105

  • Assistance Publique- Hopitaux /ID# 160552

    Paris, 75020

  • Hopital Haut-Lévêque /ID# 160558

    Pessac, Gironde, 33604

  • Hospital Pontchaillou /ID# 160555

    Rennes, 35033

Other trials in France

Portugal6 sites

  • Centro Hospitalar Lisboa Norte, EPE /ID# 158687

    Lisbon, Lisbon District, 1769-001

  • IPO Lisboa FG, EPE /ID# 158995

    Lisbon, 1099-023

  • Hospital da Luz, SA /ID# 158996

    Lisbon, 1500-650

  • Unidade Local Saude Matosinhos /ID# 158682

    Matosinhos Municipality, 4464-513

  • Hospital CUF Porto /ID# 158685

    Porto, 4100-180

  • IPO Porto FG, EPE /ID# 158686

    Porto, 4200-072

Other trials in Portugal

United Kingdom6 sites

  • United Lincolnshire Hospitals /ID# 159579

    Boston, PE21 9QS

  • Guy's and St Thomas' NHS Found /ID# 159581

    London, London, City of, SE1 9RT

  • Charing Cross Hospital /ID# 159582

    London, W6 8RF

  • Christie NHS Foundation Trust /ID# 159099

    Manchester, M20 4BX

  • James Cook University Hospital /ID# 159583

    Middlesbrough, TS4 3BW

  • Royal Preston Hospital /ID# 159578

    Preston, PR2 9HT

Other trials in United Kingdom

Brazil5 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159017

    Barretos, São Paulo, 14784-400

  • Liga Norte Rio Grandense Cont. /ID# 159015

    Natal, Rio Grande do Norte, 59075-740

  • Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159668

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159665

    Rio de Janeiro, 20231-050

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666

    São José do Rio Preto, São Paulo, 15090-000

Other trials in Brazil

Canada5 sites

  • Cross Cancer Institute /ID# 159519

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Clinic /ID# 159514

    Hamilton, Ontario, L8V 1C3

  • Hopital du Sacre Coeur Montreal /ID# 159515

    Montreal, Quebec, H4J 1C5

  • CHU de Quebec-Universite Laval /ID# 159093

    Québec, Quebec, G1R 2J6

  • Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 208931

    Rimouski, Quebec, G5L 5T1

Other trials in Canada

Czechia5 sites

  • Nemocnice Rudolfa a Stefanie /ID# 159652

    Benešov, 256 01

  • Nemocnice Horovice a.s. /ID# 161191

    Hořovice, 268 31

  • Krajska nemocnice Liberec a.s. /ID# 159653

    Liberec, 602 00

  • Nemocnice Na Plesi s.r.o. /ID# 161190

    Nová Ves pod Pleší, Pribram, 262 04

  • Thomayerova nemocnice /ID# 159061

    Prague, Praha 4, 140 59

Other trials in Czechia

Italy5 sites

  • AUSL 8 Arezzo Ospedale San Don /ID# 160967

    Arezzo, 52100

  • Istituto Europeo di Oncologia /ID# 158942

    Milan, 20141

  • A.O.U. San Luigi Gonzaga /ID# 158945

    Orbassano, 10043

  • Ospedale Santa Maria delle Cro /ID# 158940

    Ravenna, 48121

  • IFO Istituto Nazionale Tumori /ID# 158941

    Rome, 00144

Other trials in Italy

Spain5 sites

  • Hospital Clinic /ID# 159031

    Barcelona, 08036

  • Hospital Santa Creu i Sant Pau /ID# 159028

    Barcelona, 08041

  • Hospital General Universitario Gregorio Maranon /ID# 159025

    Madrid, 28007

  • Hospital Universitario HM Sanchinarro /ID# 159024

    Madrid, 28050

  • Hospital Clinico Universitario de Valencia /ID# 159027

    Valencia, 46010

Other trials in Spain

Turkey (Türkiye)5 sites

  • Hacettepe University Medical Faculty /ID# 159238

    Altindağ, Ankara, 06250

  • Inonu Universitesi Turgut Ozal /ID# 159241

    Battalgazi/malatya, 44280

  • Ege University Medical Faculty /ID# 159239

    Izmir, 35040

  • Dr. Suat Seren Gogus Has /ID# 159240

    Izmir, 35110

  • Ataturk Gogus Hastaliklari ve /ID# 160056

    Kecioren/ankara, 06280

Other trials in Turkey (Türkiye)

Greece4 sites

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159165

    Athens, 11527

  • Metropolitan Hospital /ID# 159162

    Athens, 18547

  • University Hospital of Ioannin /ID# 159163

    Ioannina, 45500

  • Euromedica General Clinic /ID# 159161

    Thessaloniki, 54645

Other trials in Greece

Serbia4 sites

  • Institut za onkologiju i radio /ID# 160058

    Belgrade, 11000

  • Klinicki centar Srbije /ID# 160024

    Belgrade, 11000

  • Institute For Pulmonary Diseas /ID# 158813

    Kamenitz, 21204

  • Clinical Center of Nis /ID# 160059

    Niš, Nisavski Okrug, 18000

Other trials in Serbia

Taiwan4 sites

  • Taichung Veterans General Hosp /ID# 158866

    Taichung, 40705

  • National Cheng Kung University Hospital /ID# 158844

    Tainan, Tainan, 70403

  • National Taiwan University Hospital /ID# 158865

    Taipei City, Taipei, 100

  • Tri-Service General Hospital /ID# 158985

    Taipei City, Taipei, 11490

Other trials in Taiwan

Belarus3 sites

  • Bobruysk Interdistrict Onco. /ID# 169394

    Babruysk, 213825

  • State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159325

    Lesnoy, 223040

  • Mogilev Reg. Oncologic dispe /ID# 159326

    Mogilev, 212018

Other trials in Belarus

Croatia3 sites

  • Klinicki bolnicki centar Rijeka /ID# 159501

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 158811

    Zagreb, City of Zagreb, 10000

  • Klinika za plucne bolesti Jordanovac /ID# 159502

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Denmark3 sites

  • Rigshospitalet, Finsen Centre /ID# 158051

    Copenhagen, 2100

  • Herlev Hospital /ID# 158049

    Herlev, Capital Region, 2730

  • Odense Universitets Hospital /ID# 158050

    Odense C, Region Syddanmark, 5000

Other trials in Denmark

Netherlands3 sites

  • Universitair Medisch Centrum Groningen /ID# 158088

    Groningen, 9713 GZ

  • Ziekenhuis St. Jansdal /ID# 158652

    Harderwijk, 3844 DG

  • Isala /ID# 158653

    Zwolle, 8025 AB

Other trials in Netherlands

Poland3 sites

  • Copernicus PL Sp. z o. o., WCO /ID# 160538

    Gdansk, 80-219

  • Szpitale Pomorskie Sp. z o.o /ID# 160536

    Gdynia, 81-519

  • Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537

    Rzeszów, Podkarpackie Voivodeship, 35-021

Other trials in Poland

Romania3 sites

  • Spitalul Judetean de Urgenta A /ID# 160846

    Alba, 510077

  • S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847

    Craiova, Dolj, 200347

  • Oncocenter Oncologie Clinica S /ID# 160848

    Timișoara, Timiș County, 300166

Other trials in Romania

Bulgaria2 sites

  • UMHAT Tsaritsa Joanna - ISUL /ID# 159641

    Sofia, 1527

  • UMHAT Sv. Ivan Rilski /ID# 159642

    Sofia, 1612

Other trials in Bulgaria

Latvia2 sites

  • Pauls Stradins Clinical /ID# 158713

    Riga, LV-1002

  • Riga East Clinical University /ID# 158714

    Riga, LV-1079

Other trials in Latvia

Mexico2 sites

  • Health Pharma Professional Research S.A de C.V /ID# 160020

    Del. Benito Juárez, 03810

  • Centro de Investigación Clinica Chapultepec /ID# 161000

    Morelia, Michoacán, 58260

Other trials in Mexico

Singapore2 sites

  • National University Hospital /ID# 158802

    Singapore, 119074

  • National Cancer Ctr Singapore /ID# 158803

    Singapore, 169610

Other trials in Singapore

Sweden2 sites

  • Sahlgrenska US Gbg /ID# 159534

    Gothenburg, Västra Götaland County, 413 46

  • Uppsala University Hospital /ID# 159050

    Uppsala, 75185

Other trials in Sweden

China1 site

  • Jilin Cancer Hosptial /ID# 204059

    Changchun, Jilin, 130000

Other trials in China

About this study

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)

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.

Being tested
Rovalpituzumab tesirine, Topotecan, Dexamethasone
Keywords
Small cell lung cancer (SCLC), Delta-like protein 3 (DLL3), rovalpituzumab tesirine, topotecan, metastatic
Medical subject headings
Small Cell Lung Carcinoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rovalpituzumab tesirineDrug

    Also called Rova-T

    Powder for solution for infusion in vials.

  • TopotecanDrug

    Powder or solution for infusion in vials. Topotecan is commercially available as both a powder and solution for infusion. Availability will vary by region.

  • DexamethasoneDrug

    Oral tablet.

Study groups in NCT03061812
Study groupRoleWhat they receive
Rovalpituzumab tesirineExperimentalRovalpituzumab 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.
Receives: Drug: Rovalpituzumab tesirine; Drug: Dexamethasone
TopotecanActive comparatorTopotecan 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.
Receives: Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (5)

  1. 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.

    Measured: 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.

  2. 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).

    Measured: Baseline, Week 7

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study start11 Apr 2017
  3. Primary completion12 Feb 2020
  4. Study completion12 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03061812
Sponsor's protocol ID
M16-289
Other IDs
2016-003726-17, 2016
Acronym
TAHOE
Status last verified
Feb 2021
First submitted
20 Feb 2017
Last updated
23 Feb 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Publications

  • 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.

    PubMed 31506387

  • 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.

    PubMed 29290251

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rovalpituzumab tesirine, Topotecan and Dexamethasone in people with Small Cell Lung Cancer, run by AbbVie at 195 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 195 sites in United States, Japan, Russia, South Korea, Ukraine and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03061812, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in