A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring c-Met Overexpressing Non-Small Cell Lung Cancer, c-Met NSCLC, Telisotuzumab Vedotin, ABBV-399, Docetaxel, Cancer, Non Small Cell Lung Cancer, NSCLC, TeliMET NSCLC-01, Teliso-V
Eligibility Criteria
Inclusion Criteria:
- Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
Archival or fresh tumor material must be submitted for assessment of c-Met levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.
- If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
- A histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
- A known epidermal growth factor receptor (EGFR) activating mutation status.
- Actionable alterations in genes other than EGFR .
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
- Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:
- Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.
- Participants with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
- Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and:
- There is no evidence of progression of CNS metastases at least 2 weeks after definitive therapy.
- They are asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 2 weeks prior to first dose of telisotuzumab vedotin.
Exclusion Criteria:
- Participants with adenosquamous histology.
- Actionable epidermal growth factor receptor (EGFR) activating mutations.
- Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
- Participants who have received prior docetaxel therapy.
A history of other malignancies except:
- Malignancy treated with curative intent and with no known active disease present for >=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without current evidence of disease.
- A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Unresolved adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
- Major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
- Clinically significant condition(s) as listed in the protocol.
Sites / Locations
- The Oncology Institute of Hope and Innovation - DTLA /ID# 239774Recruiting
- Eisenhower Medical Center /ID# 233189Recruiting
- Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228Recruiting
- Kaiser Permanente Moanalua Medical Center /ID# 238363Recruiting
- Edward-Elmhurst Cancer Center /ID# 238552Recruiting
- Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190Recruiting
- Hattiesburg Clinic /ID# 248033Recruiting
- Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567Recruiting
- Hulston Cancer Center /ID# 232226Recruiting
- Renown Medical Group - Oncology/Hematology /ID# 247942Recruiting
- San Juan Oncology Associates /ID# 244387Recruiting
- Maimonides Medical Center /ID# 240783Recruiting
- First Health of the Carolinas /ID# 241279Recruiting
- Genesis Cancer Care Center /ID# 239190Recruiting
- Avera Cancer Institute /ID# 239635Recruiting
- Valley Medical Center /ID# 253950Recruiting
- Centro Médico Austral /ID# 239860Recruiting
- Cenit /Id# 239880Recruiting
- Hospital Britanico de Buenos Aires /ID# 231495Recruiting
- Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339Recruiting
- Barwon Health /ID# 241920Recruiting
- Austin Health /ID# 247507Recruiting
- Ordensklinikum Linz GmbH Elisabethinen /ID# 240967Recruiting
- Klinikum Wels-Grieskirchen GmbH /ID# 249000Recruiting
- Landeskrankenhaus Feldkirch /ID# 250333Recruiting
- Medizinische Universitaet Wien /ID# 230615Recruiting
- Klinik Penzing /ID# 230700Recruiting
- Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467Recruiting
- Universitair Ziekenhuis Antwerpen /ID# 239971Recruiting
- Grand Hopital de Charleroi /ID# 234178Recruiting
- AZ Klina /ID# 239853Recruiting
- Pôle Hospitalier Jolimont /ID# 246771Recruiting
- CHU UCL Namur - Sainte Elisabeth /ID# 246769Recruiting
- Ensino e Terapia de Inovacao Clínica AMO - Etica /ID# 231604Recruiting
- Irmandade da Santa Casa de Misericórdia de Porto Alegre /ID# 233249Recruiting
- Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247Recruiting
- Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 231509Recruiting
- Instituto D'or de Pesquisa e Ensino /ID# 233245Recruiting
- Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417Recruiting
- Casa de Saúde Santa Marcelina /ID# 231605Recruiting
- Complex Oncology Center - Burgas /ID# 240532Recruiting
- UMHAT Sofiamed /ID# 234108Recruiting
- UMHAT Sveta Marina /ID# 234112Recruiting
- Clinica Universidad Catolica del Maule /ID# 231294Recruiting
- Icegclinic /Id# 231212Recruiting
- Sociedad Prosalud Montes y Orlandi /ID# 231154Recruiting
- Fundacion Arturo Lopez Perez /ID# 231151Recruiting
- Sociedad Oncovida /ID# 231152Recruiting
- Anhui Chest Hospital /ID# 231899Recruiting
- Peking Union Medical College Hospital /ID# 233175Recruiting
- Beijing Chest Hospital, Capital Medical University /ID# 232202Recruiting
- Fujian Provincial Cancer Hospital /ID# 243134Recruiting
- The First Affiliated Hospital of Xiamen University /ID# 242381Recruiting
- The First Affiliated Hospital of Guangzhou Medical University /ID# 238591Recruiting
- Cancer Hospital of Shantou University Medical College /ID# 242182Recruiting
- Affiliated Hospital Of Guangdong Medical University /ID# 233317Recruiting
- Guizhou Provincial People's Hospital /ID# 243614Recruiting
- Affiliated Hospital of Hebei University /ID# 239586Recruiting
- Harbin Medical University Cancer Hospital /ID# 231941Recruiting
- The First affiliated Hospital of Nanyang Medical College /ID# 244652Recruiting
- Henan Provincial People's Hospital /ID# 242187Recruiting
- Henan Cancer Hospital /ID# 239577Recruiting
- Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231904Recruiting
- Tongji Hospital Tongji Medical College of HUST /ID# 239575Recruiting
- Hubei Cancer Hospital /ID# 240045Recruiting
- Nanjing Drum Tower Hospital /ID# 231791Recruiting
- Nantong Tumor Hospital /ID# 232424Recruiting
- The First Affiliated Hospital of Nanchang University /ID# 231934Recruiting
- The Second Affiliated Hospital of Nanchang University /ID# 231935Recruiting
- The First Hospital of China Medical University /ID# 231924Recruiting
- Jinan Central Hospital /ID# 231895Recruiting
- Shandong Cancer Hospital /ID# 251506Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023Recruiting
- Sichuan Cancer Hospital /ID# 239707Recruiting
- West China Hospital, Sichuan University /ID# 233703Recruiting
- Tianjin Medical University Cancer Institute and Hospital /ID# 233176Recruiting
- Zhejiang Cancer hospital /ID# 242476Recruiting
- Taizhou Hospital, Zhejiang Province /ID# 232021Recruiting
- The Second Hospital of Dalian Medical University /ID# 239755Recruiting
- Linyi Cancer Hospital /ID# 239713Recruiting
- Ningbo No. 2 Hospital /ID# 242478Recruiting
- Shanghai Chest Hospital /ID# 231897Recruiting
- Tianjin Medical University General Hospital /ID# 231839Recruiting
- Masarykuv onkologicky ustav /ID# 232426Recruiting
- Nemocnice AGEL Novy Jicin, a.s. /ID# 232427Recruiting
- Odense University Hospital /ID# 241663Recruiting
- CHU Bordeaux - Hopital Haut Leveque /ID# 244953Recruiting
- Hopital Arnaud de Villeneuve /ID# 239404Recruiting
- AP-HP - Hopital Cochin /ID# 239409Recruiting
- AP-HP - Hopital Tenon /ID# 239179Recruiting
- Universitatsklinikum Mannheim /ID# 238331Recruiting
- Universitaetsklinikum Jena /ID# 239661Recruiting
- Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 239658Recruiting
- Thoraxklinik Heidelberg gGmbH /ID# 239656Recruiting
- Klinikum Kassel /ID# 240142Recruiting
- General Hospital of Chest Diseases of Athens SOTIRIA /ID# 230824Recruiting
- Metropolitan Hospital /ID# 239170Recruiting
- The Edith Wolfson Medical Center /ID# 233781Recruiting
- Ziv Medical Center /ID# 238606Recruiting
- Azienda Ospedaliera San Giovanni Addolorata /ID# 238618Recruiting
- Azienda Ospedaliera di Perugia /ID# 238473Recruiting
- I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696Recruiting
- Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698Recruiting
- ASST Sette Laghi /ID# 238536Recruiting
- NHO Nagoya Medical Center /ID# 246306Recruiting
- Nagoya University Hospital /ID# 239990Recruiting
- Hirosaki University Hospital /ID# 242377Recruiting
- National Cancer Center Hospital East /ID# 233775Recruiting
- National Hospital Organization Kyushu Medical Center /ID# 238533Recruiting
- Hospital of the University of Occupational and Environmental Health, Japan /ID# 241191Recruiting
- Fukushima Medical University Hospital /ID# 249691Recruiting
- Gunma Prefectural Cancer Center /ID# 233723Recruiting
- Chugoku Central Hospital /ID# 242970Recruiting
- Hiroshima University Hospital /ID# 241882Recruiting
- Hokkaido University Hospital /ID# 241289Recruiting
- Kobe Minimally Invasive Cancer Center /ID# 254131Recruiting
- Takarazuka City Hospital /ID# 240786Recruiting
- National Hospital Organization Mito Medical Center /ID# 241709Recruiting
- Ibaraki Prefectural Central Hospital /ID# 246145Recruiting
- Iwate Medical University Hospital /ID# 239027Recruiting
- Kitasato University Hospital /ID# 239958Recruiting
- Yokohama City University Medical Center /ID# 246554Recruiting
- Kanagawa Cardiovascular and Respiratory Center /ID# 239052Recruiting
- Kumamoto University Hospital /ID# 241039Recruiting
- National Hospital Organization Mie Chuo Medical Center /ID# 246659Recruiting
- Miyagi Cancer Center /ID# 234198Recruiting
- Sendai Kousei Hospital /ID# 253350Recruiting
- University of Miyazaki Hospital /ID# 242161Recruiting
- Nagaoka Red Cross Hospital /ID# 240714Recruiting
- Kurashiki Central Hospital /ID# 239344Recruiting
- Osaka Habikino Medical Center /ID# 239989Recruiting
- Kansai Medical University Hospital /ID# 233476Recruiting
- Osaka Metropolitan University Hospital /ID# 238895Recruiting
- Kindai University Hospital /ID# 239085Recruiting
- Tochigi Cancer Center /ID# 240020Recruiting
- Juntendo University Hospital /ID# 239932Recruiting
- National Hospital Organization Tokyo Medical Center /ID# 246581Recruiting
- NTT Medical Center Tokyo /ID# 241067Recruiting
- Keio University Hospital /ID# 239506Recruiting
- Toyama University Hospital /ID# 241660Recruiting
- Wakayama Medical University Hospital /ID# 234004Recruiting
- Yamagata University Hospital /ID# 240815
- Fujieda Municipal General Hospital /ID# 255155Recruiting
- CHA University Bundang Medical Center /ID# 233318Recruiting
- Ajou University Hospital /ID# 233319Recruiting
- Gyeongsang National University Hospital /ID# 234244Recruiting
- Kangbuk Samsung Hospital /ID# 233711Recruiting
- SMG-SNU Boramae Medical Center /ID# 233710Recruiting
- Clinical Research & Oncology Oaxaca /ID# 231883Recruiting
- HagaZiekenhuis /ID# 243693Recruiting
- Ziekenhuis St. Jansdal /ID# 251932Recruiting
- Maastricht Universitair Medisch Centrum /ID# 233932Recruiting
- Isala /ID# 238846Recruiting
- Instytut Centrum Zdrowia Matki Polki /ID# 239024Recruiting
- MRUK-MED I Sp. z o.o. /ID# 239363Recruiting
- Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025Recruiting
- Fundação Champalimaud /ID# 241925Recruiting
- Hospital CUF Porto /ID# 241570Recruiting
- Oncocenter - Oncologie Clinica Srl /Id# 239103Recruiting
- Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826Recruiting
- Sc Oncolab Srl /Id# 239105Recruiting
- SC RTC Radiology Therapeutic Center SRL /ID# 240744Recruiting
- S.C. Sigmedical Services SRL /ID# 239108Recruiting
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084Recruiting
- Wits Clinical Research Site /ID# 230841Recruiting
- Sandton Oncology Medical Group PTY Ltd /ID# 230843
- UOMi Cancer Center - Clinica Tres Torres /ID# 240584Recruiting
- Hospital Universitario de Jaen /ID# 240588Recruiting
- Hospital Universitario 12 de Octubre /ID# 240176Recruiting
- Hospital Clinico Universitario de Valencia /ID# 240378Recruiting
- Sahlgrenska University Hospital /ID# 229943Recruiting
- Karolinska University Hospital /ID# 229853Recruiting
- Changhua Christian Hospital /ID# 238394Recruiting
- National Taiwan University Hospital - Hsinchu branch /ID# 238393Recruiting
- Hualien Tzu Chi Hospital /ID# 238398Recruiting
- E-DA Cancer Hospital /ID# 239718Recruiting
- Chung Shan Medical University Hospital /ID# 238444Recruiting
- National Taiwan University Hospital /ID# 238378Recruiting
- MacKay Memorial Hospital /ID# 238392Recruiting
- Taipei Medical University Hospital /ID# 238380Recruiting
- Memorial Ankara Hastanesi /ID# 234212Recruiting
- Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 234209Recruiting
- Adana Acibadem Hospital /ID# 234208Recruiting
- Ankara City Hospital /ID# 234210Recruiting
- Inonu Universitesi Turgut Ozal /ID# 234038Recruiting
- Uludag University Medical Faculty /ID# 234205Recruiting
- Dicle Universitesi Tip /ID# 234036Recruiting
- Bagcilar Medipol Mega Universite Hastanesi /ID# 234211Recruiting
- Ege University Medical Faculty /ID# 234039Recruiting
- Nottingham University Hospitals NHS Trust /ID# 254707Recruiting
- The Christie Hospital /ID# 243422Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Telisotuzumab Vedotin
Docetaxel
Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.