Lung Cancer Clinical Trial
Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Summary
This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).
Eligibility Criteria
Inclusion Criteria:
Have locally advanced or metastatic non-small cell lung cancer (NSCLC).
Have c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. Participant must submit archival or fresh tumor material for assessment of c-Met levels during the prescreening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, subject can submit fresh biopsy material for reassessment of c-Met expression.
Histologically documented non-squamous epidermal growth factor receptor (EGFR) wild type NSCLC (site documented EGFR status). Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met. As of Protocol Version 11, Stage 1 is complete and Stage 2 is enrolling participants with non-squamous EGFR wild type NSCLC only.
Must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting.
Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same tyrosine kinase (TK) count as 1 line of therapy for the purposes of this eligibility criterion.
Progressed on systemic cytotoxic therapy (or are ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible), and prior anticancer therapies targeting driver gene alterations (if applicable).
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Treatment with any therapies within the noted time intervals is excluded prior to the first dose of telisotuzumab vedotin as noted in the protocol.
Metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided within the protocol.
Exclusion Criteria:
Have received radiation therapy to the lungs < 6 months prior to the first dose of telisotuzumab vedotin.
Have received any live vaccine within 30 days of the first dose of investigational product.
Has adenosquamous histology.
Have a history of other malignancies except those noted within the protocol.
Have a history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids.
Have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD within 3 months of the planned first dose of the study drug (Except for Sites in Ireland). For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
For Sites in Ireland Only: Must not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD. For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
Have a clinically significant condition(s) as noted in the protocol.
Have unresolved clinically significant adverse events of Grade >= 2 from prior anticancer therapy, except for alopecia or anemia.
Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
For Sites in France and Czech Republic Only: Have the following:
Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not required for eligibility for this protocol unless mandated by local regulatory authority or ethics committee/institutional review board.
Active hepatitis B virus (HBV) infection, defined by hepatitis B surface antigen (HBsAg) positivity or HBV DNA >= 500 IU/mL. In participants with known HBV infection, the presence of active infection must be tested locally. If HBV status is unknown, it must be tested locally at screening.
Active hepatitis C virus (HCV) infection, defined by HCV ribonucleic acid (RNA) positivity. Participants cured of HCV infection may be included in the study. In participants with known HCV infection, the presence of active infection must be tested locally. If HCV status is unknown, it must be tested locally at screening.
Uncontrolled autoimmune disease.
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There are 250 Locations for this study
Mobile Alabama, 36604, United States
Phoenix Arizona, 85054, United States
Springdale Arkansas, 72762, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Sacramento California, 95816, United States
Whittier California, 90603, United States
Aurora Colorado, 80045, United States
Lone Tree Colorado, 80124, United States
Brooksville Florida, 34613, United States
Celebration Florida, 34747, United States
Jacksonville Florida, 32224, United States
Orlando Florida, 32804, United States
Honolulu Hawaii, 96813, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Evanston Illinois, 60201, United States
Harvey Illinois, 60426, United States
Joliet Illinois, 60435, United States
Goshen Indiana, 46526, United States
Kansas City Kansas, 66160, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40503, United States
Louisville Kentucky, 40207, United States
Lewiston Maine, 04240, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
West Bloomfield Michigan, 48322, United States
Rochester Minnesota, 55905, United States
Hattiesburg Mississippi, 39401, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63110, United States
Billings Montana, 59102, United States
Lebanon New Hampshire, 03756, United States
East Brunswick New Jersey, 08816, United States
Morristown New Jersey, 07960, United States
Pennington New Jersey, 08534, United States
Summit New Jersey, 07901, United States
Albuquerque New Mexico, 87102, United States
Canton Ohio, 44718, United States
Cleveland Ohio, 44106, United States
Elyria Ohio, 44024, United States
Oklahoma City Oklahoma, 73120, United States
Portland Oregon, 97225, United States
Hershey Pennsylvania, 17033, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15240, United States
Knoxville Tennessee, 37916, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Temple Texas, 76508, United States
Fairfax Virginia, 22031, United States
Renton Washington, 98055, United States
Seattle Washington, 98109, United States
Milwaukee Wisconsin, 53226, United States
Darlinghurst New South Wales, 2010, Australia
Lambton Heights New South Wales, 2305, Australia
Tweed Heads New South Wales, 2485, Australia
South Brisbane Queensland, 4101, Australia
Subiaco Western Australia, 6008, Australia
Edegem Antwerpen, 2650, Belgium
Anderlecht , 1070, Belgium
Gent , 9000, Belgium
Hasselt , 3500, Belgium
Kortrijk , 8500, Belgium
La Louvière , 7100, Belgium
Liege , 4000, Belgium
Namur , 5000, Belgium
Sint-Niklaas , 9100, Belgium
Dobrich , 9300, Bulgaria
Pleven , 5800, Bulgaria
Sofia , 1330, Bulgaria
Sofia , 1407, Bulgaria
Edmonton Alberta, T6G 1, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Hefei Anhui, 23000, China
Hefei Anhui, 23002, China
Hefei Anhui, 23003, China
Beijing Beijing, 10014, China
Fuzhou Fujian, 35001, China
Guangzhou Guangdong, 51016, China
Nanning Guangxi, 53002, China
Baoding Hebei, 07100, China
Harbin Heilongjiang, 15008, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43002, China
Changzhou Jiangsu, 21300, China
Changchun Jilin, 13001, China
Jinan Shandong, 25160, China
Shanghai Shanghai, 20003, China
Chengdu Sichuan, 61004, China
Urumqi Xinjiang, 83000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31002, China
Shanghai , 20003, China
Praha , 128 0, Czechia
Praha , 155 0, Czechia
Marseille Bouches-du-Rhone, 13015, France
Bordeaux Gironde, 33000, France
Lille Hauts-de-France, 59037, France
Paris CEDEX 05 Ile-de-France, 75248, France
Lyon CEDEX 08 Rhone, 69373, France
Creteil Val-de-Marne, 94000, France
Villejuif Cedex Val-de-Marne, 94805, France
Bron , 69500, France
Strasbourg cedex , 67091, France
Toulon , 83056, France
Mannheim Baden-Wuerttemberg, 68167, Germany
Augsburg Bayern, 86150, Germany
Gießen Hessen, 35392, Germany
Halle (Saale) Sachsen-Anhalt, 06120, Germany
Berlin , 12351, Germany
Gauting , 82131, Germany
Hamm , 59063, Germany
Kassel , 34125, Germany
Oldenburg , 26121, Germany
Athens Attiki, 11527, Greece
Piraeus Attiki, 18547, Greece
Heraklion Kriti, 71500, Greece
Thessaloniki , 54622, Greece
Thessaloniki , 54645, Greece
Encs Borsod-Abauj-Zemplen, 3860, Hungary
Torokbalint Pest, 2045, Hungary
Budapest , 1085, Hungary
Farkasgyepu , 8582, Hungary
Matrahaza , 3233, Hungary
Wilton Cork, T12 E, Ireland
Dublin 7 Dublin, D07 R, Ireland
Dublin 8 Dublin, D08 N, Ireland
Elm Park Dublin, D04 T, Ireland
Be'er Sheva HaDarom, 84439, Israel
Ramat Gan Tel-Aviv, 52656, Israel
Haifa , 31096, Israel
Kfar Saba , 44281, Israel
Petakh Tikva , 49414, Israel
Rome Lazio, 00128, Italy
Rome Lazio, 00152, Italy
Milan Milano, 20132, Italy
Orbassano Torino, 10043, Italy
Avellino , 83100, Italy
Bologna , 40138, Italy
Meldola , 47014, Italy
Napoli , 80138, Italy
Parma , 43126, Italy
Rome , 00144, Italy
Nagoya-shi Aichi, 457-8, Japan
Nagoya-shi Aichi, 464-8, Japan
Hirosaki-shi Aomori, 036-8, Japan
Chiba-shi Chiba, 260-8, Japan
Matsuyama-shi Ehime, 791-0, Japan
Fukuoka-shi Fukuoka, 811-1, Japan
Kurume-shi Fukuoka, 830-0, Japan
Fukuyama-shi Hiroshima, 720-0, Japan
Himeji-shi Hyogo, 670-8, Japan
Kobe-shi Hyogo, 650-0, Japan
Takarazuka-shi Hyogo, 665-0, Japan
Yokohama-shi Kanagawa, 221-0, Japan
Yokohama-shi Kanagawa, 241-8, Japan
Matsusaka-shi Mie, 515-8, Japan
Sendai-shi Miyagi, 980-0, Japan
Niigata-shi Niigata, 951-8, Japan
Okayama-shi Okayama, 700-8, Japan
Osaka-shi Osaka, 534-0, Japan
Osaka-shi Osaka, 541-8, Japan
Sakai-shi Osaka, 591-8, Japan
Kitaadachi-gun Saitama, 362-0, Japan
Sunto-gun Shizuoka, 411-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Koto-ku Tokyo, 135-8, Japan
Ube-shi Yamaguchi, 755-0, Japan
Fujieda-shi , 426-8, Japan
Hiroshima-shi , 730-8, Japan
Goyang Gyeonggido, 10408, Korea, Republic of
Seongnam Gyeonggido, 13620, Korea, Republic of
Suwon Gyeonggido, 16247, Korea, Republic of
Yangsan-si Gyeongsangnamdo, 50612, Korea, Republic of
Cheongju , 28644, Korea, Republic of
Incheon , 22332, Korea, Republic of
Jeonnam , 58128, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Amsterdam Noord-Holland, 1066 , Netherlands
Amersfoort , 3813 , Netherlands
Harderwijk , 3844 , Netherlands
Lodz Lodzkie, 90-54, Poland
Warsaw Mazowieckie, 02-78, Poland
Przemysl Podkarpackie, 37-70, Poland
Poznan Wielkopolskie, 60-69, Poland
Szczecin Zachodniopomorskie, 70-78, Poland
San Juan , 00921, Puerto Rico
San Juan , 00959, Puerto Rico
Craiova Dolj, 20034, Romania
Ploiesti Prahova, 10033, Romania
Bucharest , 02232, Romania
Bucharest , 03017, Romania
Bucharest , 03142, Romania
Cluj Napoca , 40001, Romania
Timisoara , 30023, Romania
Novosibirsk Novosibirskaya Oblast, 63009, Russian Federation
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Kazan Tatarstan, Respublika, 42002, Russian Federation
Volgograd Volgogradskaya Oblast, 40013, Russian Federation
Arkhangelsk , 16304, Russian Federation
Chelyabinsk , 45404, Russian Federation
Kostroma , 15600, Russian Federation
Krasnoyarsk , 66013, Russian Federation
Moscow , 10902, Russian Federation
Moscow , 12130, Russian Federation
Obninsk , 24903, Russian Federation
Omsk , 64401, Russian Federation
Pushkin , 19660, Russian Federation
Pyatigorsk , 35751, Russian Federation
St. Petersburg , 19734, Russian Federation
Santiago de Compostela A Coruna, 15706, Spain
Badalona Barcelona, 08916, Spain
Las Palmas de Gran Canaria Las Palmas, 35016, Spain
Alcorcon Madrid, 28922, Spain
Avila , 05004, Spain
Barcelona , 08028, Spain
Barcelona , 08035, Spain
Madrid , 28034, Spain
Madrid , 28050, Spain
Malaga , 29011, Spain
Sevilla , 41009, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Basel Basel-Stadt, 4031, Switzerland
Winterthur Zuerich, 8400, Switzerland
Kaohsiung City Kaohsiung, 833, Taiwan
Chia-Yi , 62247, Taiwan
Kaohsiung , 807, Taiwan
New Taipei City , 23561, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Taipei City , 100, Taiwan
Taipei , 112, Taiwan
Taoyuan City , 333, Taiwan
Adana , 01060, Turkey
Ankara , 06200, Turkey
Ankara , 06560, Turkey
Antalya , 07059, Turkey
Edirne, Istanbul , 22030, Turkey
Istanbul , 34722, Turkey
Izmir , 35110, Turkey
London London, City Of, E1 2E, United Kingdom
Nottingham Nottinghamshire, NG5 1, United Kingdom
Oxford Oxfordshire, OX3 9, United Kingdom
Birmingham , B15 2, United Kingdom
London , NW1 2, United Kingdom
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