Lung Cancer Clinical Trial
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)
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 250 sites worldwide.
Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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.
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.
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There are 166 Locations for this study
Los Angeles California, 90015, United States
Rancho Mirage California, 92270, United States
Ocala Florida, 34474, United States
Honolulu Hawaii, 96819, United States
Elmhurst Illinois, 60126, United States
Ypsilanti Michigan, 48197, United States
Springfield Missouri, 65807, United States
Reno Nevada, 89502, United States
Farmington New Mexico, 87401, United States
Brooklyn New York, 11219, United States
Pinehurst North Carolina, 28374, United States
Zanesville Ohio, 43701, United States
Sioux Falls South Dakota, 57105, United States
Ciudad Autonoma Buenos Aires Ciuadad Autonoma De Buenos Aires, 1019, Argentina
Ciudad Autonoma de Buenos Aire Ciuadad Autonoma De Buenos Aires, 1125, Argentina
Ciudad Autonoma de Buenos Aire Ciuadad Autonoma De Buenos Aires, 1280, Argentina
Viedma Rio Negro, 8500, Argentina
Geelong Victoria, 3220, Australia
Heidelberg Victoria, 3084, Australia
Linz Oberoesterreich, 4010, Austria
Wels Oberoesterreich, 4600, Austria
Feldkirch Vorarlberg, 6800, Austria
Vienna Wien, 1090, Austria
Vienna Wien, 1140, Austria
Salzburg , 5020, Austria
Edegem Antwerpen, 2650, Belgium
Charleroi Hainaut, 6000, Belgium
Brasschaat , 2930, Belgium
Salvador Bahia, 41830, Brazil
Porto Alegre Rio Grande Do Sul, 90020, Brazil
Barretos Sao Paulo, 14784, Brazil
Rio de Janeiro , 20231, Brazil
Rio de Janeiro , 22281, Brazil
Sao Paulo , 01236, Brazil
Sao Paulo , 08270, Brazil
Burgas , 8000, Bulgaria
Sofia , 1797, Bulgaria
Varna , 9010, Bulgaria
Talca Maule, 34613, Chile
La Florida Region Metropolitana De Santiago, 82414, Chile
Providencia Region Metropolitana De Santiago, 75007, Chile
Providencia Region Metropolitana Santiago, 75009, Chile
Providencia Region Metropolitana Santiago, 75100, Chile
Hefei Anhui, 23002, China
Beijing Beijing, 10114, China
Fuzhou Fujian, 35001, China
Xiamen Fujian, 36100, China
Shantou Guangdong, 51504, China
Zhanjiang Guangdong, 52400, China
Harbin Heilongjiang, 15008, China
Nanyang Henan, 47300, China
Zhengzhou Henan, 45000, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43003, China
Wuhan Hubei, 43007, China
Nanjing Jiangsu, 21000, China
Nantong Jiangsu, 22630, China
Nanchang Jiangxi, 33000, China
Jinan Shandong, 25001, China
Xian Shanxi, 71006, China
Chengdu Sichuan, 61004, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30022, China
Hangzhou Zhejiang, 31002, China
Taizhou Zhejiang, 31701, China
Dalian , 11602, China
Linyi , 27600, China
Ningbo , 31501, China
Shanghai , 20003, China
Tianjin , 30005, China
Brno , 656 5, Czechia
Novy Jicin , 741 0, Czechia
Odense C Syddanmark, 5000, Denmark
Pessac Gironde, 33604, France
Montpellier Cedex 5 , 34295, France
Paris , 75014, France
Paris , 75020, France
Kassel , 34125, Germany
Piraeus Attiki, 18547, Greece
Holon , 58220, Israel
Safed , 13100, Israel
Rome Roma, 00184, Italy
Perugia Umbria, 06129, Italy
Bari , 70124, Italy
Cremona , 26100, Italy
Varese , 21100, Italy
Nagoya-shi Aichi, 460-0, Japan
Nagoya-shi Aichi, 46685, Japan
Hirosaki-shi Aomori, 036-8, Japan
Kashiwa-shi Chiba, 277-8, Japan
Fukuoka shi Fukuoka, 810-8, Japan
Kitakyushu-shi Fukuoka, 807-8, Japan
Fukushima-shi Fukushima, 960-1, Japan
Ota-shi Gunma, 373-8, Japan
Fukuyama-shi Hiroshima, 720-0, Japan
Hiroshima-shi Hiroshima, 734-8, Japan
Sapporo-shi Hokkaido, 060-8, Japan
Kobe-shi Hyogo, 650-0, Japan
Takarazuka-shi Hyogo, 665-0, Japan
Higashi Ibaraki-gun Ibaraki, 311-3, Japan
Kasama-shi Ibaraki, 309-1, Japan
Shiwa-gun Iwate, 028-3, Japan
Sagamihara-shi Kanagawa, 252-0, Japan
Yokohama shi Kanagawa, 232-0, Japan
Yokohama-shi Kanagawa, 236-0, Japan
Kumamoto shi Kumamoto, 86085, Japan
Tsu-shi Mie, 514-1, Japan
Natori-shi Miyagi, 981-1, Japan
Sendai-shi Miyagi, 980-0, Japan
Miyazaki-shi Miyazaki, 889-1, Japan
Nagaoka-shi Niigata, 940-2, Japan
Kurashiki-shi Okayama, 710-8, Japan
Habikino-shi Osaka, 583-8, Japan
Hirakata-shi Osaka, 573-1, Japan
Osaka-shi Osaka, 545-8, Japan
Osakasayama-shi Osaka, 589-8, Japan
Utsunomiya-shi Tochigi, 320-0, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Shinagawa-ku Tokyo, 141-8, Japan
Shinjuku-ku Tokyo, 160-8, Japan
Toyama-shi Toyama, 930-0, Japan
Wakayama-shi Wakayama, 641-8, Japan
Yamagata-shi Yamagata, 990-9, Japan
Seongnam si Gyeonggido, 13496, Korea, Republic of
Suwon Gyeonggido, 16499, Korea, Republic of
Jinju Gyeongsangnamdo, 52727, Korea, Republic of
Seoul Seoul Teugbyeolsi, 03181, Korea, Republic of
Seoul Seoul Teugbyeolsi, 07061, Korea, Republic of
Den Haag , 2545 , Netherlands
Maastricht , 6229 , Netherlands
Zwolle , 8025 , Netherlands
Lodz Lodzkie, 93-33, Poland
Rzeszow Podkarpackie, 35-02, Poland
Olsztyn Warminsko-mazurskie, 10-35, Poland
Timisoara Timis, 30016, Romania
Brasov , 50028, Romania
Craiova , 20038, Romania
Otopeni , 07510, Romania
Suceava , 72021, Romania
Banska Bystrica , 975 1, Slovakia
Johannesburg Gauteng, 2193, South Africa
Johannesburg Gauteng, 2196, South Africa
Barcelona , 08017, Spain
Jaen , 23007, Spain
Madrid , 28041, Spain
Valencia , 46010, Spain
Gothenburg Vastra Gotalands Lan, 413 4, Sweden
Stockholm , 171 7, Sweden
Changhua City, Changhua County , 50006, Taiwan
Hsinchu City , 30059, Taiwan
Hualien City , 97002, Taiwan
Kaohsiung City , 82445, Taiwan
Taichung , 40201, Taiwan
Taipei City , 100, Taiwan
Taipei City , 10449, Taiwan
Taipei City , 11031, Taiwan
Ã‡ankaya Ankara, 06520, Turkey
Karsiyaka Izmir, 35575, Turkey
Adana , 01130, Turkey
Ankara , 06800, Turkey
Battalgazi/malatya , 44280, Turkey
Bursa , 16059, Turkey
Diyarbakir , 21200, Turkey
Istanbul , 34214, Turkey
Izmir , 35040, Turkey
Manchester , M20 4, United Kingdom
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