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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)

Primary Purpose

Non Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Telisotuzumab Vedotin
Docetaxel
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Telisotuzumab Vedotin

Docetaxel

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Overall Survival (OS)
OS is defined as the time from randomization to the event of death from any cause.

Secondary Outcome Measures

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
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.
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.
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.
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.
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.

Full Information

First Posted
June 14, 2021
Last Updated
October 23, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04928846
Brief Title
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)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
June 7, 2025 (Anticipated)
Study Completion Date
March 21, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
698 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telisotuzumab Vedotin
Arm Type
Experimental
Arm Description
Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
Arm Title
Docetaxel
Arm Type
Active Comparator
Arm Description
Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.
Intervention Type
Biological
Intervention Name(s)
Telisotuzumab Vedotin
Other Intervention Name(s)
ABBV-399
Intervention Description
Intravenous (IV) Infusion
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
IV Infusion
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) per Independent Central Review (ICR)
Description
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.
Time Frame
Up to approximately 39 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to the event of death from any cause.
Time Frame
Up to approximately 39 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR), per ICR.
Description
ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) based on RECIST v1.1
Time Frame
Up to approximately 58.25 months
Title
Duration of Response (DoR), per ICR
Description
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.
Time Frame
Up to approximately 58.25 months
Title
PFS per Investigator Assessment
Description
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.
Time Frame
Up to approximately 58.25 months
Title
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)
Description
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.
Time Frame
Up to approximately 58.25 months
Title
Time to Deterioration of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).
Description
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.
Time Frame
Up to approximately 58.25 months
Title
Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30.
Description
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.
Time Frame
Up to approximately 58.25 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
The Oncology Institute of Hope and Innovation - DTLA /ID# 239774
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015-3070
Country
United States
Individual Site Status
Recruiting
Facility Name
Eisenhower Medical Center /ID# 233189
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270-3221
Country
United States
Individual Site Status
Recruiting
Facility Name
Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474-4445
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente Moanalua Medical Center /ID# 238363
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819-1469
Country
United States
Individual Site Status
Recruiting
Facility Name
Edward-Elmhurst Cancer Center /ID# 238552
City
Elmhurst
State/Province
Illinois
ZIP/Postal Code
60126
Country
United States
Individual Site Status
Recruiting
Facility Name
Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197-1051
Country
United States
Individual Site Status
Recruiting
Facility Name
Hattiesburg Clinic /ID# 248033
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114-4859
Country
United States
Individual Site Status
Recruiting
Facility Name
Hulston Cancer Center /ID# 232226
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807-5287
Country
United States
Individual Site Status
Recruiting
Facility Name
Renown Medical Group - Oncology/Hematology /ID# 247942
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502-1464
Country
United States
Individual Site Status
Recruiting
Facility Name
San Juan Oncology Associates /ID# 244387
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Individual Site Status
Recruiting
Facility Name
Maimonides Medical Center /ID# 240783
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Individual Site Status
Recruiting
Facility Name
First Health of the Carolinas /ID# 241279
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Cancer Care Center /ID# 239190
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701-1406
Country
United States
Individual Site Status
Recruiting
Facility Name
Avera Cancer Institute /ID# 239635
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Name
Valley Medical Center /ID# 253950
City
Renton
State/Province
Washington
ZIP/Postal Code
98055-5738
Country
United States
Individual Site Status
Recruiting
Facility Name
Centro Médico Austral /ID# 239860
City
Ciudad Autonoma Buenos Aires
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
1019
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cenit /Id# 239880
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
1125
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Britanico de Buenos Aires /ID# 231495
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339
City
Viedma
State/Province
Rio Negro
ZIP/Postal Code
8500
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Barwon Health /ID# 241920
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health /ID# 247507
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Ordensklinikum Linz GmbH Elisabethinen /ID# 240967
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
4010
Country
Austria
Individual Site Status
Recruiting
Facility Name
Klinikum Wels-Grieskirchen GmbH /ID# 249000
City
Wels
State/Province
Oberoesterreich
ZIP/Postal Code
4600
Country
Austria
Individual Site Status
Recruiting
Facility Name
Landeskrankenhaus Feldkirch /ID# 250333
City
Feldkirch
State/Province
Vorarlberg
ZIP/Postal Code
6800
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Wien /ID# 230615
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Klinik Penzing /ID# 230700
City
Vienna
State/Province
Wien
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Name
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Antwerpen /ID# 239971
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Grand Hopital de Charleroi /ID# 234178
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Klina /ID# 239853
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Pôle Hospitalier Jolimont /ID# 246771
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU UCL Namur - Sainte Elisabeth /ID# 246769
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Ensino e Terapia de Inovacao Clínica AMO - Etica /ID# 231604
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41830-907
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre /ID# 233249
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 231509
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto D'or de Pesquisa e Ensino /ID# 233245
City
Rio de Janeiro
ZIP/Postal Code
22281-100
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417
City
Sao Paulo
ZIP/Postal Code
01236-030
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Casa de Saúde Santa Marcelina /ID# 231605
City
Sao Paulo
ZIP/Postal Code
08270-070
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Complex Oncology Center - Burgas /ID# 240532
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Sofiamed /ID# 234108
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Sveta Marina /ID# 234112
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinica Universidad Catolica del Maule /ID# 231294
City
Talca
State/Province
Maule
ZIP/Postal Code
3461341
Country
Chile
Individual Site Status
Recruiting
Facility Name
Icegclinic /Id# 231212
City
La Florida
State/Province
Region Metropolitana De Santiago
ZIP/Postal Code
8241479
Country
Chile
Individual Site Status
Recruiting
Facility Name
Sociedad Prosalud Montes y Orlandi /ID# 231154
City
Providencia
State/Province
Region Metropolitana De Santiago
ZIP/Postal Code
7500713
Country
Chile
Individual Site Status
Recruiting
Facility Name
Fundacion Arturo Lopez Perez /ID# 231151
City
Providencia
State/Province
Region Metropolitana Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Name
Sociedad Oncovida /ID# 231152
City
Providencia
State/Province
Region Metropolitana Santiago
ZIP/Postal Code
7510032
Country
Chile
Individual Site Status
Recruiting
Facility Name
Anhui Chest Hospital /ID# 231899
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Individual Site Status
Recruiting
Facility Name
Peking Union Medical College Hospital /ID# 233175
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Chest Hospital, Capital Medical University /ID# 232202
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Provincial Cancer Hospital /ID# 243134
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xiamen University /ID# 242381
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Guangzhou Medical University /ID# 238591
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510163
Country
China
Individual Site Status
Recruiting
Facility Name
Cancer Hospital of Shantou University Medical College /ID# 242182
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital Of Guangdong Medical University /ID# 233317
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524001
Country
China
Individual Site Status
Recruiting
Facility Name
Guizhou Provincial People's Hospital /ID# 243614
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550002
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Hebei University /ID# 239586
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin Medical University Cancer Hospital /ID# 231941
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Name
The First affiliated Hospital of Nanyang Medical College /ID# 244652
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473007
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Provincial People's Hospital /ID# 242187
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital /ID# 239577
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231904
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital Tongji Medical College of HUST /ID# 239575
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Hubei Cancer Hospital /ID# 240045
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Drum Tower Hospital /ID# 231791
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
Nantong Tumor Hospital /ID# 232424
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226300
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 231934
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Nanchang University /ID# 231935
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330008
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of China Medical University /ID# 231924
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Name
Jinan Central Hospital /ID# 231895
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Cancer Hospital /ID# 251506
City
Jinan
State/Province
Shandong
ZIP/Postal Code
251601
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Cancer Hospital /ID# 239707
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University /ID# 233703
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer Institute and Hospital /ID# 233176
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer hospital /ID# 242476
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
Taizhou Hospital, Zhejiang Province /ID# 232021
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317013
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Dalian Medical University /ID# 239755
City
Dalian
ZIP/Postal Code
116027
Country
China
Individual Site Status
Recruiting
Facility Name
Linyi Cancer Hospital /ID# 239713
City
Linyi
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Name
Ningbo No. 2 Hospital /ID# 242478
City
Ningbo
ZIP/Postal Code
315010
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Chest Hospital /ID# 231897
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital /ID# 231839
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Masarykuv onkologicky ustav /ID# 232426
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Nemocnice AGEL Novy Jicin, a.s. /ID# 232427
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Odense University Hospital /ID# 241663
City
Odense C
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
CHU Bordeaux - Hopital Haut Leveque /ID# 244953
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Arnaud de Villeneuve /ID# 239404
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP - Hopital Cochin /ID# 239409
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP - Hopital Tenon /ID# 239179
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Mannheim /ID# 238331
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Jena /ID# 239661
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 239658
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Thoraxklinik Heidelberg gGmbH /ID# 239656
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Kassel /ID# 240142
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Individual Site Status
Recruiting
Facility Name
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 230824
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Metropolitan Hospital /ID# 239170
City
Piraeus
State/Province
Attiki
ZIP/Postal Code
18547
Country
Greece
Individual Site Status
Recruiting
Facility Name
The Edith Wolfson Medical Center /ID# 233781
City
Holon
ZIP/Postal Code
5822000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Ziv Medical Center /ID# 238606
City
Safed
ZIP/Postal Code
13100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera San Giovanni Addolorata /ID# 238618
City
Rome
State/Province
Roma
ZIP/Postal Code
00184
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera di Perugia /ID# 238473
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06129
Country
Italy
Individual Site Status
Recruiting
Facility Name
I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Sette Laghi /ID# 238536
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Name
NHO Nagoya Medical Center /ID# 246306
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital /ID# 239990
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hirosaki University Hospital /ID# 242377
City
Hirosaki-shi
State/Province
Aomori
ZIP/Postal Code
036-8203
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East /ID# 233775
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kyushu Medical Center /ID# 238533
City
Fukuoka shi
State/Province
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hospital of the University of Occupational and Environmental Health, Japan /ID# 241191
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukushima Medical University Hospital /ID# 249691
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gunma Prefectural Cancer Center /ID# 233723
City
Ota-shi
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chugoku Central Hospital /ID# 242970
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
720-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima University Hospital /ID# 241882
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital /ID# 241289
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe Minimally Invasive Cancer Center /ID# 254131
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0046
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takarazuka City Hospital /ID# 240786
City
Takarazuka-shi
State/Province
Hyogo
ZIP/Postal Code
665-0827
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Mito Medical Center /ID# 241709
City
Higashi Ibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ibaraki Prefectural Central Hospital /ID# 246145
City
Kasama-shi
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Individual Site Status
Recruiting
Facility Name
Iwate Medical University Hospital /ID# 239027
City
Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitasato University Hospital /ID# 239958
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center /ID# 246554
City
Yokohama shi
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Cardiovascular and Respiratory Center /ID# 239052
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kumamoto University Hospital /ID# 241039
City
Kumamoto shi
State/Province
Kumamoto
ZIP/Postal Code
8608556
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Mie Chuo Medical Center /ID# 246659
City
Tsu-shi
State/Province
Mie
ZIP/Postal Code
514-1101
Country
Japan
Individual Site Status
Recruiting
Facility Name
Miyagi Cancer Center /ID# 234198
City
Natori-shi
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sendai Kousei Hospital /ID# 253350
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Miyazaki Hospital /ID# 242161
City
Miyazaki-shi
State/Province
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagaoka Red Cross Hospital /ID# 240714
City
Nagaoka-shi
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurashiki Central Hospital /ID# 239344
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Habikino Medical Center /ID# 239989
City
Habikino-shi
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kansai Medical University Hospital /ID# 233476
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Metropolitan University Hospital /ID# 238895
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital /ID# 239085
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tochigi Cancer Center /ID# 240020
City
Utsunomiya-shi
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Hospital /ID# 239932
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Tokyo Medical Center /ID# 246581
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+81-3-3411-0111
Facility Name
NTT Medical Center Tokyo /ID# 241067
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keio University Hospital /ID# 239506
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toyama University Hospital /ID# 241660
City
Toyama-shi
State/Province
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Wakayama Medical University Hospital /ID# 234004
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamagata University Hospital /ID# 240815
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Completed
Facility Name
Fujieda Municipal General Hospital /ID# 255155
City
Fujieda-shi
ZIP/Postal Code
426-8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
CHA University Bundang Medical Center /ID# 233318
City
Seongnam si
State/Province
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ajou University Hospital /ID# 233319
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gyeongsang National University Hospital /ID# 234244
City
Jinju
State/Province
Gyeongsangnamdo
ZIP/Postal Code
52727
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kangbuk Samsung Hospital /ID# 233711
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
SMG-SNU Boramae Medical Center /ID# 233710
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Clinical Research & Oncology Oaxaca /ID# 231883
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Recruiting
Facility Name
HagaZiekenhuis /ID# 243693
City
Den Haag
ZIP/Postal Code
2545 AA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Ziekenhuis St. Jansdal /ID# 251932
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht Universitair Medisch Centrum /ID# 233932
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Isala /ID# 238846
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Instytut Centrum Zdrowia Matki Polki /ID# 239024
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
MRUK-MED I Sp. z o.o. /ID# 239363
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-021
Country
Poland
Individual Site Status
Recruiting
Facility Name
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-357
Country
Poland
Individual Site Status
Recruiting
Facility Name
Fundação Champalimaud /ID# 241925
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital CUF Porto /ID# 241570
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Oncocenter - Oncologie Clinica Srl /Id# 239103
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300166
Country
Romania
Individual Site Status
Recruiting
Facility Name
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Recruiting
Facility Name
Sc Oncolab Srl /Id# 239105
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Individual Site Status
Recruiting
Facility Name
SC RTC Radiology Therapeutic Center SRL /ID# 240744
City
Otopeni
ZIP/Postal Code
075100
Country
Romania
Individual Site Status
Recruiting
Facility Name
S.C. Sigmedical Services SRL /ID# 239108
City
Suceava
ZIP/Postal Code
720214
Country
Romania
Individual Site Status
Recruiting
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Wits Clinical Research Site /ID# 230841
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Sandton Oncology Medical Group PTY Ltd /ID# 230843
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Individual Site Status
Completed
Facility Name
UOMi Cancer Center - Clinica Tres Torres /ID# 240584
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Jaen /ID# 240588
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre /ID# 240176
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia /ID# 240378
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sahlgrenska University Hospital /ID# 229943
City
Gothenburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska University Hospital /ID# 229853
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Changhua Christian Hospital /ID# 238394
City
Changhua City, Changhua County
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital - Hsinchu branch /ID# 238393
City
Hsinchu City
ZIP/Postal Code
30059
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Hualien Tzu Chi Hospital /ID# 238398
City
Hualien City
ZIP/Postal Code
97002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
E-DA Cancer Hospital /ID# 239718
City
Kaohsiung City
ZIP/Postal Code
82445
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chung Shan Medical University Hospital /ID# 238444
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital /ID# 238378
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
MacKay Memorial Hospital /ID# 238392
City
Taipei City
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University Hospital /ID# 238380
City
Taipei City
ZIP/Postal Code
11031
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Memorial Ankara Hastanesi /ID# 234212
City
Çankaya
State/Province
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 234209
City
Karsiyaka
State/Province
Izmir
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Adana Acibadem Hospital /ID# 234208
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara City Hospital /ID# 234210
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Inonu Universitesi Turgut Ozal /ID# 234038
City
Battalgazi/malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Uludag University Medical Faculty /ID# 234205
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dicle Universitesi Tip /ID# 234036
City
Diyarbakir
ZIP/Postal Code
21200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Bagcilar Medipol Mega Universite Hastanesi /ID# 234211
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege University Medical Faculty /ID# 234039
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Nottingham University Hospitals NHS Trust /ID# 254707
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie Hospital /ID# 243422
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this 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)

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