A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Sponsor
AbbVie (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05513703
Collaborator
(none)
70
55
1
48
1.3
0

Study Details

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 how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed.

Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide.

Participants will receive IV telisotuzumab vedotin every 2 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Telisotuzumab Vedotin
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Anticipated Study Start Date :
Nov 16, 2022
Anticipated Primary Completion Date :
Nov 15, 2025
Anticipated Study Completion Date :
Nov 15, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telisotuzumab Vedotin

Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.

Biological: Telisotuzumab Vedotin
Intravenous (IV) Infusion
Other Names:
  • ABBV-399
  • Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) as Assessed by an Independent Central Review (ICR) [Up to 1 Year]

      ORR will be defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

    Secondary Outcome Measures

    1. Duration of Response (DoR) [Up to 1 Year]

      DoR will be defined for confirmed responders as the time from the initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1, or death from any cause.

    2. Disease Control Rate (DCR) [Up to 1 Year]

      DCR will be defined as the percentage of participants with best overall response of confirmed CR or confirmed PR, or stable disease (SD) for at least 12 weeks following first dose of study drug, based on RECIST, version 1.1.

    3. Progression Free Survival (PFS) per ICR [Up to 1 Year]

      PFS will be defined as the time from the participant's first dose of study drug to the first occurrence of radiographic progression based on RECIST, version 1.1 or death from any cause.

    4. Overall Survival (OS) [Up to 2 Years]

      OS will be defined as the time from participant's first dose of study drug to the event of death from any cause.

    5. Time to Deterioration in Cough [Up to 1 Year]

      Time to deterioration in cough as measured by the cough items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13).

    6. Time to Deterioration in Pain [Up to 1 Year]

      Time to deterioration in pain as measured by the cough items of the EORTC QLQ-LC13.

    7. Time to Deterioration in Dyspnea [Up to 1 Year]

      Time to deterioration in dyspnea as measured by the cough items of the EORTC QLQ-LC13.

    8. Time to Deterioration of Physical Functioning [Up to 1 Year]

      Time to deterioration of physical functioning as measured by the physical functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).

    9. Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). [Up to 1 Year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory or in plasma and/or tissue by a Sponsor-approved assay.

    • Must have histologically documented non-squamous cell non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.

    • Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

    • Participant may have received prior adjuvant/neoadjuvant systemic chemotherapy and/or radiation if it was completed >= 6 months before participant's first dose of study drug.

    • Metastases to the central nervous system (CNS) are eligible only after definitive therapy is provided as noted in the protocol.

    • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

    Exclusion Criteria:
    • Have adenosquamous histology.

    • Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to targeted therapy. Participants with other alterations that are candidates for available targeted therapy.

    • Prior systemic therapy for locally advanced/metastatic NSCLC.

    • Have a history of other malignancies except those noted in the protocol.

    • Have 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.

    • Received prior c-Met-targeted antibodies.

    • Have NSCLC that is eligible for treatment with curative intent.

    • Have unresolved clinically significant adverse events (AEs) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.

    • Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.

    • Have clinically significant condition(s) as noted in the protocol.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Monash Medical Centre /ID# 247679 Clayton Victoria Australia 3168
    2 Beijing Cancer Hospital /ID# 247881 Beijing Beijing China 100142
    3 The First Affiliated Hospital of Guangzhou Medical University /ID# 247828 Guangzhou Guangdong China 510163
    4 Harbin Medical University Cancer Hospital /ID# 248982 Harbin Heilongjiang China 150081
    5 Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 247882 Wuhan Hubei China 430022
    6 Renmin Hospital of Wuhan University /ID# 249019 Wuhan Hubei China 430060
    7 Shandong Cancer Hospital /ID# 247823 Jinan Shandong China 251601
    8 West China Hospital, Sichuan University /ID# 247783 Chengdu Sichuan China 610041
    9 The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 249068 Hangzhou Zhejiang China 310006
    10 Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 247840 Hangzhou Zhejiang China 310020
    11 Zhejiang Cancer hospital /ID# 248958 Hangzhou Zhejiang China 310022
    12 Sichuan Cancer Hospital /ID# 247909 Chengdu China 610041
    13 Chongqing University Three Gorges Hospital /ID# 247772 Chongqing China 404199
    14 Shanghai Chest Hospital /ID# 247826 Shanghai China 200030
    15 Zhongshan Hospital Fudan University /ID# 247771 Shanghai China 200032
    16 Tongji Hospital Tongji Medical College of HUST /ID# 249018 Wuhan China 430030
    17 CHU Lille - Hôpital Albert Calmette /ID# 246263 Lille Hauts-de-France France 59037
    18 HCL - Hôpital Louis Pradel /ID# 246267 Bron France 69500
    19 Centre Jean Perrin /ID# 246268 Clermont Ferrand France 63011
    20 Asklepios Fachkliniken Muenchen-Gauting /ID# 248082 Gauting Germany 82131
    21 The Chaim Sheba Medical Center /ID# 243207 Ramat Gan Tel-Aviv Israel 5265601
    22 Rambam Health Care Campus /ID# 246781 Haifa Israel 3109601
    23 Hadassah Medical Center-Hebrew University /ID# 243298 Jerusalem Israel 91120
    24 Meir Medical Center /ID# 243208 Kfar Saba Israel 4428164
    25 Rabin Medical Center /ID# 248631 Petakh Tikva Israel 4941492
    26 Ospedale San Raffaele IRCCS /ID# 247588 Milan Lombardia Italy 20132
    27 ASST Monza/Ospedale San Gerardo /ID# 247584 Monza Monza E Brianza Italy 20900
    28 Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 248329 Candiolo Torino Italy 10060
    29 Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 249156 Ancona Italy 60126
    30 IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 247585 Rome Italy 00144
    31 Pusan National University Yangsan Hospital /ID# 248489 Yangsan-si Gyeongsangnamdo Korea, Republic of 50612
    32 Yonsei University Health System Severance Hospital /ID# 248404 Seoul Seoul Teugbyeolsi Korea, Republic of 03722
    33 Chungbuk National Univ Hosp /ID# 248405 Cheongju Korea, Republic of 28644
    34 Keimyung University Dongsan Medical Center /ID# 247371 Daegu Korea, Republic of 41931
    35 Samsung Medical Center /ID# 248407 Seoul Korea, Republic of 06351
    36 Spitalul Municipal Ploiesti /ID# 248609 Ploiesti Prahova Romania 100337
    37 Institutul Oncologic Prof Dr I Chiricuta /ID# 248610 Cluj Napoca Romania 400015
    38 S.C. Radiotherapy Center Cluj SRL /ID# 248639 Cluj Romania 407280
    39 Hospital Duran i Reynals /ID# 248117 Hospitalet de Llobregat Barcelona Spain 08907
    40 CHU Insular-Materno Infantil /ID# 248121 Las Palmas de Gran Canaria Las Palmas Spain 35016
    41 Hospital Universitario Fundacion Alcorcon /ID# 248116 Alcorcon Madrid Spain 28922
    42 Hospital Universitario Dexeus - Grupo Quironsalud /ID# 248125 Barcelona Spain 08028
    43 Hospital Clinico Universitario Lozano Blesa /ID# 248126 Zaragoza Spain 50009
    44 Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 248144 Kaohsiung Taiwan 807
    45 Kaohsiung Chang Gung Memorial Hospital /ID# 248143 Kaohsiung Taiwan 833
    46 National Cheng Kung University Hospital /ID# 248142 Tainan Taiwan 704
    47 Linkou Chang Gung Memorial Hospital /ID# 248145 Taoyuan City Taiwan 333
    48 Adana Sehir Egitim ve Arastirma Hastanesi /ID# 246089 Adana Turkey 01060
    49 Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 246090 Ankara Turkey 06200
    50 Gazi University Medical Faculty /ID# 246086 Ankara Turkey 06560
    51 Akdeniz Universitesi Tip Fakul /ID# 246092 Antalya Turkey 07059
    52 Trakya University Medical Facu /ID# 246083 Edirne, Istanbul Turkey 22030
    53 Prof. Dr. Suleyman Yalcın Sehir Hastanesi /ID# 246084 Istanbul Turkey 34722
    54 Dr. Suat Seren Gogus Has /ID# 246088 Izmir Turkey 35110
    55 University Hospitals Birmingham NHS Foundation Trust /ID# 246826 Birmingham United Kingdom B15 2TH

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05513703
    Other Study ID Numbers:
    • M22-137
    • 2022-500608-23-00
    First Posted:
    Aug 24, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2022