Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer
This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress 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).
Inclusion Criteria:
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:
Lone Tree, Colorado 80124, United States
Chicago, Illinois 60611-2927, United States
Louisville, Kentucky 40207, United States
Billings, Montana 59102, United States
Lebanon, New Hampshire 03756, United States
East Brunswick, New Jersey 08816, United States
Oklahoma City, Oklahoma 73120, United States
Portland, Oregon 97225, United States
Hershey, Pennsylvania 17033-2360, United States
Lambton Heights, New South Wales 2305, Australia
Toronto, Ontario M5G 2M9, Canada
Guangzhou, Guangdong 510163, China
Wuhan, Hubei 430022, China
Ürümqi, Xinjiang 830000, China
Hangzhou, Zhejiang 310003, China
Encs, Borsod-Abauj Zemplen county 3860, Hungary
Wilton, Cork T12 E8YV, Ireland
Elm Park, Dublin D04 T6F4, Ireland
Bologna, Emilia-Romagna 40138, Italy
Meldola, Forlì-Cesena 47014, Italy
Rome, Roma 00144, Italy
Avellino, 83100, Italy
Hirosaki-shi, Aomori 036-8203, Japan
Matsuyama, Ehime 791-0280, Japan
Fukuoka, Fukuoka 811-1395, Japan
Kurume-shi, Fukuoka 830-0011, Japan
Himeji-shi, Hyōgo 670-8520, Japan
Takarazuka-shi, Hyōgo 665-0827, Japan
Matsusaka-shi, Mie-ken 515-8544, Japan
Sakai-shi, Osaka 591-8555, Japan
Kitaadachi-gun, Saitama 362-0806, Japan
Fujieda-shi, Shizuoka 426-8677, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Chuo-ku, Tokyo 104-0045, Japan
Koto-ku, Tokyo 135-8550, Japan
Ube-shi, Yamaguchi 755-0241, Japan
Warsaw, Masovian Voivodeship 02-781, Poland
Lodz, Łódź Voivodeship 90-549, Poland
Cluj-Napoca, Cluj 400015, Romania
Bucharest, 022328, Romania
Krasnoyarsk, Krasnoyarsk Krai 660133, Russia
Saint Petersburg, Sankt-Peterburg 197758, Russia
Volgograd, Volgograd Oblast 400138, Russia
Seongnam, Gyeonggido 13620, South Korea
Suwon, Gyeonggido 16247, South Korea
Hwasun-gun, Jeonranamdo 58128, South Korea
Santiago de Compostela, A Coruna 15706, Spain
Basel Town, Canton of Basel-City 4031, Switzerland
Taipei City, Taipei 100, Taiwan
Ankara, 06200, Turkey (Türkiye)
Edirne, Istanbul, 22030, Turkey (Türkiye)
London, Greater London E1 2ES, United Kingdom
Oxford, Oxfordshire OX3 9DU, United Kingdom