Lung Cancer Clinical 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)
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.
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.
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There are 190 Locations for this study
Huntsville Alabama, 35805, United States
Mobile Alabama, 36604, United States
Little Rock Arkansas, 72205, United States
Springdale Arkansas, 72762, United States
Beverly Hills California, 90211, United States
La Jolla California, 92093, United States
Los Angeles California, 90017, United States
Sacramento California, 95817, United States
Santa Rosa California, 95403, United States
Whittier California, 90603, United States
Newark Delaware, 19713, United States
Jacksonville Florida, 32256, United States
Atlanta Georgia, 30342, United States
Meridian Idaho, 83712, United States
Evanston Illinois, 60201, United States
Harvey Illinois, 60426, United States
Goshen Indiana, 46526, United States
Louisville Kentucky, 40202, United States
Baton Rouge Louisiana, 70836, United States
Boston Massachusetts, 02215, United States
Lansing Michigan, 48912, United States
Lincoln Nebraska, 68506, United States
Canton Ohio, 44718, United States
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15232, United States
Austin Texas, 78701, United States
Dallas Texas, 75390, United States
Burlington Vermont, 05401, United States
Seattle Washington, 98109, United States
Spokane Washington, 99208, United States
Morgantown West Virginia, 26506, United States
Blacktown New South Wales, 2148, Australia
Kogarah New South Wales, 2217, Australia
Wollongong New South Wales, 2500, Australia
Chermside Queensland, 4032, Australia
Ballarat Victoria, 3350, Australia
Heidelberg Victoria, 3084, Australia
Bobruisk , 21382, Belarus
Lesnoy , 22304, Belarus
Mogilev , 21201, Belarus
Bruxelles Bruxelles-Capitale, 1000, Belgium
Charleroi Hainaut, 6000, Belgium
Brussels , 1200, Belgium
Haine Saint Paul , 7100, Belgium
Leuven , 3000, Belgium
Liege , 4000, Belgium
Montigny-le-tilleul , 6110, Belgium
Natal Rio Grande Do Norte, 59075, Brazil
Passo Fundo Rio Grande Do Sul, 99010, Brazil
Barretos Sao Paulo, 14784, Brazil
Sao Jose Do Rio Preto Sao Paulo, 15090, Brazil
Rio de Janeiro , 20231, Brazil
Sofia , 1527, Bulgaria
Sofia , 1612, Bulgaria
Edmonton Alberta, T6G 1, Canada
Hamilton Ontario, L8V 1, Canada
Montreal Quebec, H4J 1, Canada
Quebec City Quebec, G1R 2, Canada
Rimouski Quebec, G5L 5, Canada
Changchun Jilin, 13000, China
Zagreb Grad Zagreb, 10000, Croatia
Zagreb Grad Zagreb, 10000, Croatia
Rijeka Primorsko-goranska Zupanija, 51000, Croatia
Prague Praha 4, 140 5, Czechia
Nová Ves pod Plešà Pribram, 262 0, Czechia
Benesov , 256 0, Czechia
Horovice , 268 3, Czechia
Liberec , 602 0, Czechia
Herlev Hovedstaden, 2730, Denmark
Odense C Syddanmark, 5000, Denmark
Copenhagen , 2100, Denmark
Pessac CEDEX Gironde, 33604, France
Marseille Provence-Alpes-Cote-d Azur, 13105, France
Lyon CEDEX 08 Rhone, 69373, France
Creteil Val-de-Marne, 94000, France
Paris , 75020, France
Rennes , 35033, France
Halle (Saale) Sachsen-Anhalt, 06120, Germany
Berlin , 13125, Germany
Gauting , 82131, Germany
Grosshansdorf , 22927, Germany
Heidelberg , 69126, Germany
Kassel , 34125, Germany
Löwenstein , 74245, Germany
Athens , 11527, Greece
Athens , 18547, Greece
Ioannina , 45500, Greece
Thessaloniki , 54645, Greece
Budapest Pest, 2045, Hungary
Budapest , 1085, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Farkasgyepu , 8582, Hungary
Gyor , 9023, Hungary
Matrahaza , 3233, Hungary
Arezzo , 52100, Italy
Milan , 20141, Italy
Orbassano , 10043, Italy
Ravenna , 48121, Italy
Rome , 00144, Italy
Nagoya-shi Aichi, 464-8, Japan
Kashiwa-shi Chiba, 277-8, Japan
Fukuoka-shi Fukuoka, 812-8, Japan
Kurume-shi Fukuoka, 830-0, Japan
Sapporo-shi Hokkaido, 003-0, Japan
Akashi-shi Hyogo, 673-8, Japan
Himeji-shi Hyogo, 670-0, Japan
Kanazawa-shi Ishikawa, 920-8, Japan
Yokohama-shi Kanagawa, 236-0, Japan
Yokohama-shi Kanagawa, 236-0, Japan
Sendai-shi Miyagi, 980-0, Japan
Okayama-shi Okayama, 700-8, Japan
Hirakata-shi Osaka, 573-1, Japan
Osaka-sayama-shi Osaka, 589-8, Japan
Osaka-shi Osaka, 534-0, Japan
Sunto-gun Shizuoka, 411-8, Japan
Tokushima-shi Tokushima, 770-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Koto-ku Tokyo, 135-8, Japan
Shinagawa-ku Tokyo, 142-0, Japan
Wakayama-shi Wakayama, 641-8, Japan
Matsusaka-shi MIE , 515-8, Japan
Yokohama , 241-0, Japan
Busan Busan Gwang Yeogsi, 49201, Korea, Republic of
Seongnam si Gyeonggido, 13496, Korea, Republic of
Gwangju Jeonranamdo, 61469, Korea, Republic of
Daegu Seoul Teugbyeolsi, 41404, Korea, Republic of
Seodaemun-gu Seoul Teugbyeolsi, 03722, Korea, Republic of
Seoul Seoul Teugbyeolsi, 08308, Korea, Republic of
Cheongju-si , 28644, Korea, Republic of
Seoul , 05505, Korea, Republic of
Riga , LV-10, Latvia
Riga , LV-10, Latvia
Morelia Michoacan, 58260, Mexico
Del. Benito Juárez , 03810, Mexico
Groningen , 9713 , Netherlands
Harderwijk , 3844 , Netherlands
Zwolle , 8025 , Netherlands
Rzeszów Podkarpackie, 35-02, Poland
Gdansk , 80-21, Poland
Gdynia , 81-51, Poland
Lisbon Lisboa, 1769-, Portugal
Lisboa , 1099-, Portugal
Lisbon , 1500-, Portugal
Matosinhos , 4464-, Portugal
Porto , 4100-, Portugal
Porto , 4200-, Portugal
Craiova Dolj, 20034, Romania
Timisoara Timis, 30016, Romania
Alba , 51007, Romania
Moscow Moskovskaya Oblast, 11547, Russian Federation
Pyatigorsk Stavropol Skiy Kray, 35750, Russian Federation
Arkhangelsk , 16304, Russian Federation
Kaluga , 28400, Russian Federation
Omsk , 64401, Russian Federation
Pushkin , 19660, Russian Federation
Smolensk , 21400, Russian Federation
St. Petersburg , 19734, Russian Federation
St. Petersburg , 19775, Russian Federation
NIS Nisavski Okrug, 18000, Serbia
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Sremska Kamenica , 21204, Serbia
Singapore , 11907, Singapore
Singapore , 16961, Singapore
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Madrid , 28007, Spain
Madrid , 28050, Spain
Valencia , 46010, Spain
Göteborg Vastra Gotalands Lan, 413 4, Sweden
Uppsala , 75185, Sweden
Tainan City Tainan, 70403, Taiwan
Taipei City Taipei, 100, Taiwan
Taipei City Taipei, 11490, Taiwan
Taichung City , 40705, Taiwan
AltindaÄŸ Ankara, 06250, Turkey
Battalgazi/malatya , 44280, Turkey
Izmir , 35040, Turkey
Izmir , 35110, Turkey
Kecioren/ankara , 06280, Turkey
Zaporizhzhia Zaporizka Oblast, 69040, Ukraine
Chernivtsi , 58013, Ukraine
Dnipro , 49102, Ukraine
Kharkiv , 61070, Ukraine
Kropyvnytskyi , 25006, Ukraine
Kryviy RIH , 50048, Ukraine
Lutsk , 43018, Ukraine
Uzhhorod , 88000, Ukraine
London London, City Of, SE1 9, United Kingdom
Boston , PE21 , United Kingdom
London , W6 8R, United Kingdom
Manchester , M20 4, United Kingdom
Middlesborough , TS4 3, United Kingdom
Preston , PR2 9, United Kingdom
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