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)
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 |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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).
- 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
Inclusion Criteria:
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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.
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Must have histologically documented non-squamous cell non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.
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Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
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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.
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Metastases to the central nervous system (CNS) are eligible only after definitive therapy is provided as noted in the protocol.
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History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Exclusion Criteria:
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Have adenosquamous histology.
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Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to targeted therapy. Participants with other alterations that are candidates for available targeted therapy.
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Prior systemic therapy for locally advanced/metastatic NSCLC.
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Have a history of other malignancies except those noted in the protocol.
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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.
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Received prior c-Met-targeted antibodies.
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Have NSCLC that is eligible for treatment with curative intent.
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Have unresolved clinically significant adverse events (AEs) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
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Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
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Have clinically significant condition(s) as noted in the protocol.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- M22-137
- 2022-500608-23-00