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)
Launched by ABBVIE · Jun 14, 2021
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called telisotuzumab vedotin for adults with non-small cell lung cancer (NSCLC) who have already received treatment in the past. Researchers want to find out if this new treatment works better than a standard chemotherapy drug called docetaxel and whether it is safe for patients. About 698 participants with a specific type of NSCLC will take part in the study, which will take place at around 300 locations worldwide. Participants will be randomly assigned to receive either telisotuzumab vedotin every two weeks or docetaxel every three weeks.
To join the trial, participants must have a confirmed diagnosis of non-squamous NSCLC that has progressed after at least one previous treatment. They should also have a life expectancy of at least 12 weeks and be well enough to receive treatment. Throughout the study, participants will have regular visits to check on their health, including blood tests and assessments for side effects. It’s important to note that the trial may require more frequent appointments and monitoring than standard treatments.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Projected life expectancy of at least 12 weeks.
- • 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 or cytologically 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 adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:
- • They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day \[QD\] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.
- Exclusion Criteria:
- • Evidence of new, untreated CNS metastases.
- • Evidence of leptomeningeal disease.
- • Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
- • 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 or neuroendocrine histology, nor sarcomatoid features adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
- • Major surgery within 21 days prior to randomization.
- • Clinically significant condition(s) as listed in the protocol.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Rancho Mirage, California, United States
Ocala, Florida, United States
Honolulu, Hawaii, United States
Elmhurst, Illinois, United States
Ypsilanti, Michigan, United States
Springfield, Missouri, United States
Reno, Nevada, United States
Farmington, New Mexico, United States
Brooklyn, New York, United States
Buffalo, New York, United States
Pinehurst, North Carolina, United States
Zanesville, Ohio, United States
Sioux Falls, South Dakota, United States
Lubbock, Texas, United States
Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Viedma, Rio Negro, Argentina
Kogarah, New South Wales, Australia
Geelong, Victoria, Australia
Heidelberg, Victoria, Australia
Linz, Oberoesterreich, Austria
Vienna, Wien, Austria
Vienna, Wien, Austria
Vienna, Wien, Austria
Salzburg, , Austria
Edegem, Antwerpen, Belgium
Charleroi, Hainaut, Belgium
Brasschaat, , Belgium
Salvador, Bahia, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Barretos, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Rio De Janeiro, , Brazil
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Burgas, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Greenfield Park, Quebec, Canada
Talca, Maule, Chile
La Florida, Region Metropolitana Santiago, Chile
Providencia, Region Metropolitana Santiago, Chile
Providencia, Region Metropolitana Santiago, Chile
Providencia, Region Metropolitana Santiago, Chile
Hefei, Anhui, China
Beijing, Beijing, China
Beijing, Beijing, China
Beijing, Beijing, China
Fuzhou, Fujian, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Shantou, Guangdong, China
Nanning, Guangxi, China
Guiyang, Guizhou, China
Baoding, Hebei, China
Harbin, Heilongjiang, China
Nanyang, Henan, China
Zhengzhou, Henan, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Changsha, Hunan, China
Huhehaote, Inner Mongolia, China
Nanjing, Jiangsu, China
Nantong, Jiangsu, China
Nanchang, Jiangxi, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
Shenyang, Liaoning, China
Shenyang, Liaoning, China
Jinan, Shandong, China
Xian, Shanxi, China
Urumqi, Xinjiang, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Taizhou, Zhejiang, China
Chengdu, , China
Chengdu, , China
Dalian, , China
Dalian, , China
Linyi, , China
Ningbo, , China
Shanghai, , China
Shanghai, , China
Tianjin, , China
Tianjin, , China
Wuhan, , China
Zhanjiang, , China
Brno, , Czechia
Novy Jicin, , Czechia
Odense C, Syddanmark, Denmark
Roskilde, , Denmark
Pessac, Gironde, France
Paris Cedex 05, Ile De France, France
Paris, Ile De France, France
Montpellier Cedex 5, , France
Paris, , France
Mannheim, Baden Wuerttemberg, Germany
Jena, Thueringen, Germany
Hamburg, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Kassel, , Germany
Athens, Attiki, Greece
Piraeus, Attiki, Greece
Holon, , Israel
Safed, , Israel
Perugia, Umbria, Italy
Bari, , Italy
Cremona, , Italy
Rome, , Italy
Varese, , Italy
Nagoya Shi, Aichi, Japan
Nagoya Shi, Aichi, Japan
Hirosaki Shi, Aomori, Japan
Kashiwa Shi, Chiba, Japan
Fukuoka Shi, Fukuoka, Japan
Kitakyushu Shi, Fukuoka, Japan
Ota Shi, Gunma, Japan
Fukuyama Shi, Hiroshima, Japan
Hiroshima Shi, Hiroshima, Japan
Sapporo Shi, Hokkaido, Japan
Takarazuka Shi, Hyogo, Japan
Higashi Ibaraki Gun, Ibaraki, Japan
Kasama Shi, Ibaraki, Japan
Shiwa Gun, Iwate, Japan
Sagamihara Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Kumamoto Shi, Kumamoto, Japan
Natori Shi, Miyagi, Japan
Miyazaki Shi, Miyazaki, Japan
Nagaoka Shi, Niigata, Japan
Kurashiki Shi, Okayama, Japan
Habikino Shi, Osaka, Japan
Hirakata Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Osakasayama Shi, Osaka, Japan
Utsunomiya Shi, Tochigi, Japan
Bunkyo Ku, Tokyo, Japan
Meguro Ku, Tokyo, Japan
Shinagawa Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Toyama Shi, Toyama, Japan
Wakayama Shi, Wakayama, Japan
Yamagata Shi, Yamagata, Japan
Seongnam Si, Gyeonggido, Korea, Republic Of
Suwon, Gyeonggido, Korea, Republic Of
Jinju, Gyeongsangnamdo, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Guadalajara, Jalisco, Mexico
Morelia, Michoacan, Mexico
Monterrey, Nuevo Leon, Mexico
Oaxaca, , Mexico
Nijmegen, Gelderland, Netherlands
Den Haag, , Netherlands
Maastricht, , Netherlands
Zwolle, , Netherlands
Lodz, Lodzkie, Poland
Rzeszow, Podkarpackie, Poland
Olsztyn, Warminsko Mazurskie, Poland
Lisboa, , Portugal
Porto, , Portugal
Porto, , Portugal
Porto, , Portugal
Porto, , Portugal
Timisoara, Timis, Romania
Brasov, , Romania
Craiova, , Romania
Otopeni, , Romania
Suceava, , Romania
Kosice, Kosicky Kraj, Slovakia
Banska Bystrica, , Slovakia
Bratislava, , Slovakia
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Barcelona, , Spain
Jaen, , Spain
Madrid, , Spain
Valencia, , Spain
Gothenburg, Vastra Gotalands Lan, Sweden
Stockholm, , Sweden
Changhua City, Changhua County, , Taiwan
Hsinchu City, , Taiwan
Hualien City, , Taiwan
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taipei City, , Taiwan
Taipei City, , Taiwan
Taipei City, , Taiwan
Karsiyaka, Izmir, Turkey
Adana, , Turkey
Ankara, , Turkey
Battalgazi/Malatya, , Turkey
Bursa, , Turkey
Diyarbakir, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Yuregir, , Turkey
çankaya, , Turkey
Belfast, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
London, , United Kingdom
Feldkirch, Vorarlberg, Austria
Salvador, Bahia, Brazil
Fukushima Shi, Fukushima, Japan
Tsu Shi, Mie, Japan
Wels, Oberoesterreich, Austria
Karsiyaka, Izmir, Turkey
Sao Paulo, , Brazil
Roskilde, , Denmark
Chengdu, Sichuan, China
Honolulu, Hawaii, United States
Innsbruck, Tirol, Austria
La Florida, Region Metropolitana De Santiago, Chile
Athens, Attiki, Greece
Chongqing, Chongqing, China
Jinan, Shandong, China
Tianjin, Tianjin, China
Kunming, Yunnan, China
Tsu Shi, Mie, Japan
çankaya, Ankara, Turkey
Wuhan, Hubei, China
Chengdu, Sichuan, China
Paris, , France
Rome, Roma, Italy
Roskilde, Sjælland, Denmark
Providencia, Region Metropolitana De Santiago, Chile
Sofia, , Bulgaria
Zhanjiang, Guangdong, China
Basel, Basel Stadt, Switzerland
Milan, Milano, Italy
Parma, , Italy
Gießen, Hessen, Germany
Piraeus, Attiki, Greece
Thessaloniki, , Greece
Kobe Shi, Hyogo, Japan
Sendai Shi, Miyagi, Japan
Lexington, Kentucky, United States
Liège, Liege, Belgium
Anderlecht, , Belgium
Gent, , Belgium
Hasselt, , Belgium
La Louvière, , Belgium
Namur, , Belgium
Los Angeles, California, United States
Renton, Washington, United States
London, London, City Of, United Kingdom
Nottingham, Nottinghamshire, United Kingdom
Fujieda Shi, , Japan
Charleston, South Carolina, United States
Marseille, Bouches Du Rhone, France
Lille, Hauts De France, France
Creteil, Val De Marne, France
Beer Sheva, Hadarom, Israel
Zhanjiang, Guangdong, China
Berlin, , Germany
Napoli, , Italy
Kurume Shi, Fukuoka, Japan
Oradea, Bihor, Romania
Cluj Napoca, Cluj, Romania
Iasi, , Romania
Harderwijk, , Netherlands
Kansas City, Missouri, United States
Alcorcon, Madrid, Spain
Fuenlabrada, Madrid, Spain
Avila, , Spain
Barcelona, , Spain
Plovdiv, , Bulgaria
Bron, , France
Hattiesburg, Mississippi, United States
Adana, , Turkey
Las Palmas De Gran Canaria, Las Palmas, Spain
Baden, Aargau, Switzerland
Salzburg, , Austria
Sao Paulo, , Brazil
Ypsilanti, Michigan, United States
Ciudad Autonoma Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Ashkelon, Hadarom, Israel
Safed, Hatsafon, Israel
Ube Shi, Yamaguchi, Japan
Chesterfield, Missouri, United States
Pretoria, Gauteng, South Africa
East Brunswick, New Jersey, United States
Seoul, , Korea, Republic Of
La Louvière, , Belgium
La Louvière, Hainaut, Belgium
Providencia, Region Metropolitana De Santiago, Chile
Providencia, Region Metropolitana De Santiago, Chile
Shanghai, Shanghai, China
Hamburg, , Germany
Chuo Ku, Tokyo, Japan
Otopeni, Ilfov, Romania
Adana, , Turkey
Hangzhou, Zhejiang, China
Goshen, Indiana, United States
Billings, Montana, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Tel Aviv, Tel Aviv, Israel
Yuma, Arizona, United States
Chesterfield, Missouri, United States
Brasschaat, , Belgium
Namur, , Belgium
Be'er Sheva, Hadarom, Israel
Cheongju, , Korea, Republic Of
Paris Cedex 14, Paris, France
Suwon, Gyeonggido, Korea, Republic Of
Duarte, California, United States
Huntington Beach, California, United States
Irvine, California, United States
Lancaster, California, United States
Aberdeen, South Dakota, United States
Spokane, Washington, United States
Liège, Liege, Belgium
Zhengzhou, Henan, China
Dalian, Liaoning, China
Xi'an, Shaanxi, China
Yangsan Si, Gyeongsangnamdo, Korea, Republic Of
Adana, , Turkey
Varna, , Bulgaria
Billings, Montana, United States
Tianjin, Tianjin, China
Varna, , Bulgaria
Goyang, Gyeonggido, Korea, Republic Of
Jassi, Iasi, Romania
Springfield, Illinois, United States
Rio De Janeiro, , Brazil
Ogden, Utah, United States
Roskilde, Sjælland, Denmark
Cheongju Si, , Korea, Republic Of
Suwon, Gyeonggido, Korea, Republic Of
성남시, Gyeonggido, Korea, Republic Of
동작구, , Korea, Republic Of
Messina, , Italy
Nottingham, Nottinghamshire, United Kingdom
Kassel, Hessen, Germany
Lisbon, Lisboa, Portugal
Beijing, Beijing, China
Fukuyama, Hiroshima, Japan
Cheongju, Chungcheongbugdo, Korea, Republic Of
Goyang Si, Gyeonggido, Korea, Republic Of
Seongnam City, Gyeonggido, Korea, Republic Of
Lisbon, Lisboa, Portugal
Johannesburg, Gauteng, South Africa
Indianapolis, Indiana, United States
Pessac Cedex, Gironde, France
Seongnam, Gyeonggido, Korea, Republic Of
Göteborg, Vastra Gotalands Lan, Sweden
Salvador, Bahia, Brazil
진주시, Gyeongsangnamdo, Korea, Republic Of
종로구, Seoul Teugbyeolsi, Korea, Republic Of
Jacksonville, Florida, United States
Charleston, South Carolina, United States
Suwon Si, Gyeonggido, Korea, Republic Of
Guadalajara, Jalisco, Mexico
Phoenix, Arizona, United States
Taiyuan, Shanxi, China
Seoul, , Korea, Republic Of
Rochester, Minnesota, United States
Taipei City, Taipei, Taiwan
Kansas City, Missouri, United States
Pinehurst, North Carolina, United States
Sofiya, Sofia, Bulgaria
Hefei, Anhui, China
Zhanjiang, Guangdong, China
Guiyang, Guizhou, China
Bron, Rhone, France
Lexington, Kentucky, United States
Xian, Shaanxi, China
Linyi, Shandong, China
Charleston, South Carolina, United States
Nanning, Guangxi, China
Linhai, Zhejiang, China
Odense, Syddanmark, Denmark
Solna, Stockholms Lan, Sweden
Taipei City, Taipei, Taiwan
Taipei City, Taipei, Taiwan
Chandler, Arizona, United States
Boston, Massachusetts, United States
Paris Cedex 05, Paris, France
Tamarac, Florida, United States
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Taipei City, Taipei, Taiwan
Birmingham, , United Kingdom
Saint Louis, Missouri, United States
Hendersonville, North Carolina, United States
Brasschaat, Limburg, Belgium
Hasselt, Limburg, Belgium
Ningbo, Guizhou, China
Tianjin, Guizhou, China
Novy Jicin, , Czechia
Montpellier Cedex 5, Haute Corse, France
Heidelberg, Saarland, Germany
Bari, L Aquila, Italy
Cremona, L Aquila, Italy
Fujieda Shi, Fukui, Japan
Den Haag, Zuid Holland, Netherlands
Harderwijk, Zuid Holland, Netherlands
Maastricht, Zuid Holland, Netherlands
Zwolle, Zuid Holland, Netherlands
Porto, Regiao Autonoma Da Madeira, Portugal
Porto, Regiao Autonoma Da Madeira, Portugal
Brasov, Olt, Romania
Craiova, Olt, Romania
Banska Bystrica, Bratislavsky Kraj, Slovakia
Avila, Burgos, Spain
Kaohsiung City, Keelung, Taiwan
Taichung, Keelung, Taiwan
Izmir, Adana, Turkey
Billings, Montana, United States
Milan, Milano, Italy
Nagoya Shi, Aichi, Japan
Taipei City, , Taiwan
Memphis, Tennessee, United States
Austin, Texas, United States
Lincoln, Nebraska, United States
Lake Success, New York, United States
York, Pennsylvania, United States
Huntington Beach, California, United States
Naples, Napoli, Italy
Rome, Roma, Italy
Perugia, , Italy
London, London, City Of, United Kingdom
Birmingham, Alabama, United States
Brasschaat, Antwerpen, Belgium
Tianjin, Tianjin, China
Ningbo, Zhejiang, China
Montpellier Cedex 5, Herault, France
Heidelberg, Baden Wuerttemberg, Germany
Fujieda Shi, Shizuoka, Japan
Harderwijk, Gelderland, Netherlands
Maastricht, Limburg, Netherlands
Zwolle, Overijssel, Netherlands
Craiova, Dolj, Romania
Banska Bystrica, Banskobystricky Kraj, Slovakia
Kaohsiung City, Kaohsiung, Taiwan
Brampton, Ontario, Canada
Varese, , Italy
London, Greater London, United Kingdom
London, Greater London, United Kingdom
Charleroi, Hainaut, Belgium
Savannah, Georgia, United States
Higashiibaraki Gun, Ibaraki, Japan
Pretoria, Gauteng, South Africa
Greenville, South Carolina, United States
Charleroi, Hainaut, Belgium
Jinan, Shandong, China
Edmonton, Alberta, Canada
Poznan, Wielkopolskie, Poland
Ciudad Autonoma De Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Brampton, Ontario, Canada
Morioka Shi, Iwate, Japan
Yuma, Arizona, United States
Yuma, Arizona, United States
Warsaw, Mazowieckie, Poland
Sint Niklaas, Oost Vlaanderen, Belgium
London, Greater London, United Kingdom
Athens, Attiki, Greece
London, Greater London, United Kingdom
Lyon Cedex 08, Rhone, France
Bogota, Distrito Capital De Bogota, Colombia
Charleroi, Hainaut, Belgium
São Paulo, Sao Paulo, Brazil
Charleroi, Hainaut, Belgium
São Paulo, Sao Paulo, Brazil
London, Greater London, United Kingdom
Roskilde, , Denmark
Madrid, , Spain
Santiago, , Chile
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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