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 Clinical Trial

Official title:

A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04928846
• Other study ID #: M18-868
• Secondary ID: 2021-001811-94
• Status: Recruiting
• Phase: Phase 3
• Start date: March 25, 2022
• Est. completion date: March 21, 2028

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 698
• Est. completion date: March 21, 2028
• Est. primary completion date: June 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Biological:
• Telisotuzumab Vedotin
Intravenous (IV) Infusion

Drug:
• Docetaxel
IV Infusion

Locations

Country	Name	City	State
Argentina	Centro Médico Austral /ID# 239860	Ciudad Autonoma Buenos Aires	Ciudad Autonoma De Buenos Aires
Argentina	Cenit /Id# 239880	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Hospital Britanico de Buenos Aires /ID# 231495	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339	Viedma	Rio Negro
Australia	Barwon Health /ID# 241920	Geelong	Victoria
Australia	Austin Health /ID# 247507	Heidelberg	Victoria
Austria	Landeskrankenhaus Feldkirch /ID# 250333	Feldkirch	Vorarlberg
Austria	Ordensklinikum Linz GmbH Elisabethinen /ID# 240967	Linz	Oberoesterreich
Austria	Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467	Salzburg
Austria	Klinik Floridsdorf /ID# 230608	Vienna	Wien
Austria	Klinik Penzing /ID# 230700	Vienna	Wien
Austria	Medizinische Universitaet Wien /ID# 230615	Vienna	Wien
Austria	Klinikum Wels-Grieskirchen GmbH /ID# 249000	Wels	Oberoesterreich
Belgium	Institut Jules Bordet /ID# 246770	Anderlecht
Belgium	Algemeen Ziekenhuis klina /ID# 239853	Brasschaat
Belgium	Grand Hopital de Charleroi /ID# 234178	Charleroi	Hainaut
Belgium	Universitair Ziekenhuis Antwerpen /ID# 239971	Edegem	Antwerpen
Belgium	AZ Maria Middelares /ID# 246768	Gent
Belgium	Jessa Ziekenhuis /ID# 246766	Hasselt
Belgium	Hospital La Louviere Site Jolimont - Helora /ID# 246771	La Louvière	Hainaut
Belgium	CHU de Liège /ID# 246772	Liège	Liege
Belgium	UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 246769	Namur
Brazil	Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247	Barretos	Sao Paulo
Brazil	Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 233249	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto D'or de Pesquisa e Ensino /ID# 233245	Rio de Janeiro
Brazil	Instituto Nacional de Cancer (INCA) /ID# 231509	Rio de Janeiro
Brazil	Ensino e Terapia de Inovacao - Clinica AMO /ID# 231604	Salvador	Bahia
Brazil	Casa de Saúde Santa Marcelina /ID# 231605	Sao Paulo
Brazil	Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417	Sao Paulo
Bulgaria	Complex Oncology Center - Burgas /ID# 240532	Burgas
Bulgaria	Complex Cancer Center Plovdiv /ID# 234106	Plovdiv
Bulgaria	University Multiprofile Hospital for Active Treatment Sofiamed /ID# 234108	Sofiya	Sofia
Bulgaria	UMHAT Sveta Marina /ID# 234112	Varna
Canada	CISSS de la Monteregie /ID# 239081	Greenfield Park	Quebec
Chile	Icegclinic /Id# 231212	La Florida	Region Metropolitana De Santiago
Chile	Fundacion Arturo Lopez Perez /ID# 231151	Providencia	Region Metropolitana De Santiago
Chile	Sociedad Oncovida /ID# 231152	Providencia	Region Metropolitana De Santiago
Chile	Sociedad Prosalud Montes y Orlandi /ID# 231154	Providencia	Region Metropolitana De Santiago
Chile	Clinica Universidad Catolica del Maule /ID# 231294	Talca	Maule
China	Affiliated Hospital of Hebei University /ID# 239586	Baoding	Hebei
China	Beijing Cancer Hospital /ID# 231923	Beijing	Beijing
China	Beijing Chest Hospital, Capital Medical University /ID# 232202	Beijing	Beijing
China	Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 233175	Beijing	Beijing
China	Jilin Cancer Hospital /ID# 244702	Changchun	Jilin
China	Hunan Cancer Hospital /ID# 231943	Changsha	Hunan
China	Sichuan Cancer Hospital /ID# 239707	Chengdu	Sichuan
China	West China Hospital, Sichuan University /ID# 233703	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University /ID# 251592	Chongqing	Chongqing
China	The Second Affiliated Hospital of Dalian Medical University /ID# 239755	Dalian	Liaoning
China	Fujian Provincial Cancer Hospital /ID# 243134	Fuzhou	Fujian
China	The First Affiliated Hospital of Guangzhou Medical University /ID# 238591	Guangzhou	Guangdong
China	People's Hospital of Guizhou Province /ID# 243614	Guiyang	Guizhou
China	The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 232032	Hangzhou	Zhejiang
China	Zhejiang Cancer hospital /ID# 242476	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital /Id# 231941	Harbin	Heilongjiang
China	Anhui Medical University - Anhui Chest Hospital /ID# 231899	Hefei	Anhui
China	The Affiliated Hospital of Inner Mongolia Medical University /ID# 242179	Huhehaote	Inner Mongolia
China	Jinan Central Hospital /ID# 231895	Jinan	Shandong
China	Shandong Cancer Hospital /ID# 251506	Jinan	Shandong
China	Yunnan Cancer Hospital /ID# 251388	Kunming	Yunnan
China	Taizhou Hospital of Zhejiang Province /ID# 232021	Linhai	Zhejiang
China	LinYi Cancer Hospital /ID# 239713	Linyi	Shandong
China	The First Affiliated Hospital of Nanchang University /ID# 231934	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University /ID# 231935	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital /ID# 231791	Nanjing	Jiangsu
China	Affiliated Cancer Hospital of Guangxi Medical University /ID# 231855	Nanning	Guangxi
China	Nantong Tumor Hospital /ID# 232424	Nantong	Jiangsu
China	The First affiliated Hospital of Nanyang Medical College /ID# 244652	Nanyang	Henan
China	Ningbo No. 2 Hospital /ID# 242478	Ningbo
China	Shanghai Chest Hospital /ID# 231897	Shanghai	Shanghai
China	Cancer Hospital of Shantou University Medical College /ID# 242182	Shantou	Guangdong
China	The First Hospital of China Medical University /ID# 231924	Shenyang	Liaoning
China	Shanxi Cancer Hospital /ID# 258674	Taiyuan	Shanxi
China	Tianjin Cancer Hospital /ID# 233176	Tianjin	Tianjin
China	Tianjin Medical University General Hospital /ID# 231839	Tianjin
China	The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 240094	Urumqi	Xinjiang
China	Hubei Cancer Hospital /ID# 240045	Wuhan	Hubei
China	Tongji Hospital Tongji Medical College of HUST /ID# 239575	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231904	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University /ID# 242381	Xiamen	Fujian
China	The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023	Xian	Shaanxi
China	Affiliated Hospital of Guangdong Medical College /ID# 233317	Zhanjiang	Guangdong
China	Henan Cancer Hospital /ID# 239577	Zhengzhou	Henan
China	People's Hospital of Henan Province /ID# 242187	Zhengzhou	Henan
Czechia	Masarykuv onkologicky ustav /ID# 232426	Brno
Czechia	Nemocnice AGEL Novy Jicin, a.s. /ID# 232427	Novy Jicin
Denmark	Odense University Hospital /ID# 241663	Odense	Syddanmark
Denmark	Roskilde Sygehus /ID# 241842	Roskilde	Sjælland
France	Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 251933	Bron	Rhone
France	Centre Hosp Intercommunal de Creteil /ID# 251936	Creteil	Val-de-Marne
France	CHU Lille - Hôpital Albert Calmette /ID# 251934	Lille	Hauts-de-France
France	APHM - Hopital Nord /ID# 251935	Marseille	Bouches-du-Rhone
France	Hopital Arnaud de Villeneuve /ID# 239404	Montpellier Cedex 5
France	AP-HP - Hopital Tenon /ID# 239179	Paris
France	Institut Curie /ID# 240141	Paris CEDEX 05	Paris
France	Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 239409	Paris CEDEX 14	Paris
France	Centre Hospitalier Universitaire de Bordeaux /ID# 244953	Pessac CEDEX	Gironde
Germany	Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 234247	Berlin
Germany	Universitaetsklinikum Giessen /ID# 252973	Gießen	Hessen
Germany	Haemato-Onkologie Hamburg /ID# 241047	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf /ID# 239658	Hamburg
Germany	Thoraxklinik Heidelberg gGmbH /ID# 239656	Heidelberg
Germany	Universitaetsklinikum Jena /ID# 239661	Jena	Thueringen
Germany	Klinikum Kassel /ID# 240142	Kassel	Hessen
Germany	Universitatsklinikum Mannheim /ID# 238331	Mannheim	Baden-Wuerttemberg
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 230824	Athens	Attiki
Greece	Metropolitan Hospital /ID# 232158	Piraeus	Attiki
Greece	Metropolitan Hospital /ID# 239170	Piraeus	Attiki
Greece	Euromedica General Clinic /ID# 254407	Thessaloniki
Israel	The Edith Wolfson Medical Center /ID# 233781	Ashkelon	HaDarom
Israel	Soroka University Medical Center /ID# 252711	Be'er Sheva	HaDarom
Israel	ZIV Medical Center /ID# 238606	Safed	HaTsafon
Israel	Tel Aviv Sourasky Medical Center /ID# 260519	Tel Aviv	Tel-Aviv
Italy	I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696	Bari
Italy	Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698	Cremona
Italy	Azienda Ospedaliera Papardo /ID# 258038	Messina
Italy	AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 252942	Napoli
Italy	Azienda Ospedaliera di Perugia /ID# 238473	Perugia	Umbria
Italy	Azienda Ospedaliera San Giovanni Addolorata /ID# 238618	Rome	Roma
Italy	ASST Sette Laghi /ID# 238536	Varese
Japan	Juntendo University Hospital /ID# 239932	Bunkyo-ku	Tokyo
Japan	National Cancer Center Hospital /ID# 251134	Chuo-ku	Tokyo
Japan	Fujieda Municipal General Hospital /ID# 255155	Fujieda-shi
Japan	National Hospital Organization Kyushu Medical Center /ID# 238533	Fukuoka shi	Fukuoka
Japan	Fukushima Medical University Hospital /ID# 249691	Fukushima-shi	Fukushima
Japan	Chugoku Central Hospital /ID# 242970	Fukuyama	Hiroshima
Japan	Osaka Habikino Medical Center /ID# 239989	Habikino-shi	Osaka
Japan	National Hospital Organization Mito Medical Center /ID# 241709	Higashi Ibaraki-gun	Ibaraki
Japan	Kansai Medical University Hospital /ID# 233476	Hirakata-shi	Osaka
Japan	Hirosaki University Hospital /ID# 242377	Hirosaki-shi	Aomori
Japan	Hiroshima University Hospital /ID# 241882	Hiroshima-shi	Hiroshima
Japan	Ibaraki Prefectural Central Hospital /ID# 246145	Kasama-shi	Ibaraki
Japan	National Cancer Center Hospital East /ID# 233775	Kashiwa-shi	Chiba
Japan	Hospital of the University of Occupational and Environmental Health, Japan /ID# 241191	Kitakyushu-shi	Fukuoka
Japan	Kobe Minimally Invasive Cancer Center /ID# 254131	Kobe-shi	Hyogo
Japan	Kumamoto University Hospital /ID# 241039	Kumamoto shi	Kumamoto
Japan	Kurashiki Central Hospital /ID# 239344	Kurashiki-shi	Okayama
Japan	Kurume University Hospital /ID# 254900	Kurume-shi	Fukuoka
Japan	National Hospital Organization Tokyo Medical Center /ID# 246581	Meguro-ku	Tokyo
Japan	University of Miyazaki Hospital /ID# 242161	Miyazaki-shi	Miyazaki
Japan	Nagaoka Red Cross Hospital /ID# 240714	Nagaoka-shi	Niigata
Japan	Nagoya University Hospital /ID# 239990	Nagoya-shi	Aichi
Japan	NHO Nagoya Medical Center /ID# 246306	Nagoya-shi	Aichi
Japan	Miyagi Cancer Center /ID# 234198	Natori-shi	Miyagi
Japan	Osaka Metropolitan University Hospital /ID# 238895	Osaka-shi	Osaka
Japan	Kindai University Hospital /ID# 239085	Osakasayama-shi	Osaka
Japan	Gunma Prefectural Cancer Center /ID# 233723	Ota-shi	Gunma
Japan	Kitasato University Hospital /ID# 239958	Sagamihara-shi	Kanagawa
Japan	Hokkaido University Hospital /ID# 241289	Sapporo-shi	Hokkaido
Japan	Sendai Kousei Hospital /ID# 253350	Sendai-shi	Miyagi
Japan	NTT Medical Center Tokyo /ID# 241067	Shinagawa-ku	Tokyo
Japan	Keio University Hospital /ID# 239506	Shinjuku-ku	Tokyo
Japan	Iwate Medical University Hospital /ID# 239027	Shiwa-gun	Iwate
Japan	Takarazuka City Hospital /ID# 240786	Takarazuka-shi	Hyogo
Japan	Toyama University Hospital /ID# 241660	Toyama-shi	Toyama
Japan	National Hospital Organization Mie Chuo Medical Center /ID# 246659	Tsu-shi	Mie
Japan	Yamaguchi - Ube Medical Center /ID# 258779	Ube-shi	Yamaguchi
Japan	Tochigi Cancer Center /ID# 240020	Utsunomiya-shi	Tochigi
Japan	Wakayama Medical University Hospital /ID# 234004	Wakayama-shi	Wakayama
Japan	Yamagata University Hospital /ID# 240815	Yamagata-shi	Yamagata
Japan	Yokohama City University Medical Center /ID# 246554	Yokohama shi	Kanagawa
Japan	Kanagawa Cardiovascular and Respiratory Center /ID# 239052	Yokohama-shi	Kanagawa
Korea, Republic of	Chungbuk National University Hospital /ID# 257891	Cheongju	Chungcheongbugdo
Korea, Republic of	National Cancer Center /ID# 260663	Goyang-si	Gyeonggido
Korea, Republic of	Gyeongsang National University Hospital /ID# 234244	Jinju	Gyeongsangnamdo
Korea, Republic of	CHA Bundang Medical Center /ID# 233318	Seongnam	Gyeonggido
Korea, Republic of	Kangbuk Samsung Hospital /ID# 233711	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 256941	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center /ID# 233710	Seoul
Korea, Republic of	The Catholic University Of Korea St. Vincent's Hospital /ID# 256942	Suwon	Gyeonggido
Korea, Republic of	Ajou University Hospital /ID# 233319	Suwon-si	Gyeonggido
Korea, Republic of	Pusan National University Yangsan Hospital /ID# 257836	Yangsan-si	Gyeongsangnamdo
Mexico	O.P.D. Hospital Civil de Guadalajara /ID# 238488	Guadalajara	Jalisco
Mexico	Centro de Investigacion Clínica Chapultepec SA de CV /ID# 231928	Morelia	Michoacan
Mexico	Clinical Research & Oncology Oaxaca /ID# 231883	Oaxaca
Netherlands	HagaZiekenhuis /ID# 243693	Den Haag
Netherlands	Ziekenhuis St. Jansdal /ID# 251932	Harderwijk
Netherlands	Maastricht Universitair Medisch Centrum /ID# 233932	Maastricht
Netherlands	Isala /ID# 238846	Zwolle
Poland	Instytut Centrum Zdrowia Matki Polki /ID# 239024	Lodz	Lodzkie
Poland	Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025	Olsztyn	Warminsko-mazurskie
Poland	MRUK-MED I Sp. z o.o. /ID# 239363	Rzeszow	Podkarpackie
Portugal	Fundacao Champalimaud /ID# 241925	Lisbon	Lisboa
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 241930	Porto
Portugal	Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 241572	Porto
Portugal	Hospital CUF Porto /ID# 241570	Porto
Portugal	IPO Porto FG, EPE /ID# 241569	Porto
Romania	Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826	Brasov
Romania	Cardiomed Srl /Id# 255320	Cluj-Napoca	Cluj
Romania	Sc Oncolab Srl /Id# 239105	Craiova
Romania	Institutul Regional de Oncologie /ID# 254065	Jassi	Iasi
Romania	Spitalul Pelican /ID# 254066	Oradea	Bihor
Romania	SC RTC Radiology Therapeutic Center SRL /ID# 240744	Otopeni	Ilfov
Romania	S.C. Sigmedical Services SRL /ID# 239108	Suceava
Romania	Oncocenter - Oncologie Clinica Srl /Id# 239103	Timisoara	Timis
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084	Banska Bystrica
South Africa	Sandton Oncology Medical Group PTY Ltd /ID# 230843	Johannesburg	Gauteng
South Africa	Wits Clinical Research /ID# 230841	Johannesburg	Gauteng
South Africa	Dept Medical Oncology, University of Pretoria and Steve Biko Academic Hospital /ID# 230883	Pretoria	Gauteng
Spain	Hospital Universitario Fundacion Alcorcon /ID# 255100	Alcorcon	Madrid
Spain	Hospital Nuestra Senora de Sonsoles /ID# 255102	Avila
Spain	Hospital Universitario Dexeus - Grupo Quironsalud /ID# 255105	Barcelona
Spain	UOMi Cancer Center - Clinica Tres Torres /ID# 240584	Barcelona
Spain	Hospital Universitario de Fuenlabrada /ID# 255093	Fuenlabrada	Madrid
Spain	Hospital Universitario de Jaen /ID# 240588	Jaen
Spain	CHU Insular-Materno Infantil /ID# 255094	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Universitario 12 de Octubre /ID# 240176	Madrid
Spain	Hospital Clinico Universitario de Valencia /ID# 240378	Valencia
Sweden	Sahlgrenska Universitetssjukhuset /ID# 229943	Göteborg	Vastra Gotalands Lan
Sweden	Karolinska University Hospital Solna /ID# 229853	Solna	Stockholms Lan
Taiwan	Changhua Christian Hospital /ID# 238394	Changhua City, Changhua County
Taiwan	National Taiwan University Hospital - Hsinchu branch /ID# 238393	Hsinchu City
Taiwan	Hualien Tzu Chi Hospital /ID# 238398	Hualien City
Taiwan	E-DA Cancer Hospital /ID# 239718	Kaohsiung City
Taiwan	Chung Shan Medical University Hospital /ID# 238444	Taichung
Taiwan	Mackay Memorial Hospital /ID# 238392	Taipei City	Taipei
Taiwan	National Taiwan University Hospital /ID# 238378	Taipei City	Taipei
Taiwan	Taipei Medical University Hospital /ID# 238380	Taipei City
Turkey	Adana Acibadem Hospital /ID# 234208	Adana
Turkey	Medical Park Seyhan Hastanesi /ID# 255637	Adana
Turkey	Ankara City Hospital /ID# 234210	Ankara
Turkey	Inonu Universitesi Turgut Ozal /ID# 234038	Battalgazi/malatya
Turkey	Uludag University Medical Faculty /ID# 234205	Bursa
Turkey	Memorial Ankara Hastanesi /ID# 234212	Çankaya	Ankara
Turkey	Dicle Universitesi Tip /ID# 234036	Diyarbakir
Turkey	Bagcilar Medipol Mega Universite Hastanesi /ID# 234211	Istanbul
Turkey	Ege University Medical Faculty /ID# 234039	Izmir
Turkey	Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 234209	Karsiyaka	Izmir
United Kingdom	Barts Health NHS Trust /ID# 254342	London	London, City Of
United Kingdom	The Royal Marsden NHS Foundation Trust /ID# 246974	London
United Kingdom	University College London Hospitals NHS Foundation Trust /ID# 249407	London
United Kingdom	The Christie Hospital /ID# 243422	Manchester
United Kingdom	Nottingham City Hospital /ID# 254707	Nottingham	Nottinghamshire
United States	Avera Cancer Institute - Aberdeen /ID# 257759	Aberdeen	South Dakota
United States	Intermountain Health - St Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147	Billings	Montana
United States	Dana-Farber Cancer Institute /ID# 247132	Boston	Massachusetts
United States	Maimonides Medical Center /ID# 240783	Brooklyn	New York
United States	Ironwood Cancer & Res Ctr /ID# 262446	Chandler	Arizona
United States	Medical University of South Carolina /ID# 251383	Charleston	South Carolina
United States	St. Luke's Hospital - Chesterfield /ID# 251688	Chesterfield	Missouri
United States	City of Hope /ID# 243157	Duarte	California
United States	Astera Cancer Care /ID# 257753	East Brunswick	New Jersey
United States	Edward-Elmhurst Cancer Center /ID# 238552	Elmhurst	Illinois
United States	San Juan Oncology Associates /ID# 244387	Farmington	New Mexico
United States	Goshen Center for Cancer Care /ID# 257734	Goshen	Indiana
United States	Hattiesburg Clinic /ID# 248033	Hattiesburg	Mississippi
United States	Kaiser Permanente Moanalua Medical Center /ID# 238363	Honolulu	Hawaii
United States	City of Hope - Huntington Beach /ID# 263143	Huntington Beach	California
United States	Investigative Clinical Research of Indiana - Indianapolis /ID# 260468	Indianapolis	Indiana
United States	City of Hope Orange County Lennar Foundation Cancer Center /ID# 263144	Irvine	California
United States	Mayo Clinic /ID# 254688	Jacksonville	Florida
United States	Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567	Kansas City	Missouri
United States	St. Luke's Hosp. of Kansas City /ID# 259940	Kansas City	Missouri
United States	City of Hope - Antelope Valley /ID# 263138	Lancaster	California
United States	Baptist Health Lexington /ID# 252769	Lexington	Kentucky
United States	The Oncology Institute of Hope and Innovation - DTLA /ID# 239774	Los Angeles	California
United States	University of California, Los Angeles /ID# 253954	Los Angeles	California
United States	Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228	Ocala	Florida
United States	Community Cancer Trials of Utah - South Ogden /ID# 262829	Ogden	Utah
United States	Mayo Clinic Arizona /ID# 255858	Phoenix	Arizona
United States	FirstHealth of the Carolinas- Speciality Center /ID# 241279	Pinehurst	North Carolina
United States	Eisenhower Medical Center /ID# 233189	Rancho Mirage	California
United States	Renown Medical Group - Oncology/Hematology /ID# 247942	Reno	Nevada
United States	Valley Medical Center /ID# 253950	Renton	Washington
United States	Mayo Clinic - Rochester /ID# 252052	Rochester	Minnesota
United States	Avera Cancer Institute /ID# 239635	Sioux Falls	South Dakota
United States	Medical Oncology Associates /ID# 247003	Spokane	Washington
United States	Hulston Cancer Center /ID# 232226	Springfield	Missouri
United States	Springfield Clinic /ID# 262290	Springfield	Illinois
United States	Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190	Ypsilanti	Michigan
United States	Yuma Regional Medical Center /ID# 253625	Yuma	Arizona
United States	Genesis Cancer Care Center /ID# 239190	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Czechia,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS) per Independent Central Review (ICR)	PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per ICR or death from any cause.	Up to approximately 39 months
Primary	Overall Survival (OS)	OS is defined as the time from randomization to the event of death from any cause.	Up to approximately 39 months
Secondary	Objective Response Rate (ORR), per ICR.	ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) based on RECIST v1.1	Up to approximately 58.25 months
Secondary	Duration of Response (DoR), per ICR	DoR is defined for responders as the time from response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause.	Up to approximately 58.25 months
Secondary	PFS per Investigator Assessment	PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 per investigator or death from any cause. Participants with no PFS event will be censored at the last evaluable radiographic assessment per investigator. Participants with no event and no evaluable post-baseline assessment will be censored at randomization.	Up to approximately 58.25 months
Secondary	Time to Deterioration in Cough, Pain or Dyspnea as measured by the Cough, Pain and Dyspnea items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)	The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30. The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts.	Up to approximately 58.25 months
Secondary	Time to Deterioration of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).	The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.	Up to approximately 58.25 months
Secondary	Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30.	The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.	Up to approximately 58.25 months