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)
- Registration Number
- NCT05513703
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- Must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory MET FISH Assay or in plasma and/or tissue by a Sponsor-approved assay.
- Must have histologically documented non-squamous adenocarcinoma 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 and/or immunotherapy provided that the subject has not progressed on or within 6 months of completing the regimen and it was completed >= 6 months before subject'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.
- Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy. Participants with other alterations that are candidates for available targeted therapy.
- Prior systemic therapy for locally advanced/metastatic NSCLC. Of note, limited treatment with no more than 1 cycle of chemotherapy is allowed prior to receiving the first dose of study drug provided there is no evidence of progression.
- 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Telisotuzumab Vedotin Telisotuzumab Vedotin Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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).
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.
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.
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.
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.
Trial Locations
- Locations (29)
Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 246267
🇫🇷Bron, Rhone, France
Monash Medical Centre /ID# 247679
🇦🇺Clayton, Victoria, Australia
CHU Lille - Hôpital Albert Calmette /ID# 246263
🇫🇷Lille, Hauts-de-France, France
Centre Jean Perrin /ID# 246268
🇫🇷Clermont Ferrand, France
Duplicate_Fondazione IRCCS San Gerardo dei Tintori /ID# 247584
🇮🇹Monza, Monza E Brianza, Italy
Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 250714
🇯🇵Fukuoka-shi, Fukuoka, Japan
Chungbuk National University Hospital /ID# 248405
🇰🇷Cheongju, Chungcheongbugdo, Korea, Republic of
Keimyung University Dongsan Hospital /ID# 247371
🇰🇷Daegu, Gyeongsangbugdo, Korea, Republic of
Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671
🇺🇸Los Alamitos, California, United States
Valley Medical Center /ID# 251880
🇺🇸Renton, Washington, United States
Asklepios Fachkliniken Muenchen-Gauting /ID# 248082
🇩🇪Gauting, Germany
Rambam Health Care Campus /ID# 246781
🇮🇱Haifa, H_efa, Israel
Meir Medical Center /ID# 243208
🇮🇱Kfar Saba, HaMerkaz, Israel
The Chaim Sheba Medical Center /ID# 243207
🇮🇱Ramat Gan, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 243298
🇮🇱Jerusalem, Yerushalayim, Israel
Rabin Medical Center /ID# 248631
🇮🇱Haifa, Israel
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 248329
🇮🇹Candiolo, Torino, Italy
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 247585
🇮🇹Rome, Italy
National Cancer Center Hospital East /ID# 250317
🇯🇵Kashiwa-shi, Chiba, Japan
Hokkaido University Hospital /ID# 250316
🇯🇵Sapporo-shi, Hokkaido, Japan
Osaka International Cancer Institute /ID# 251507
🇯🇵Osaka-shi, Osaka, Japan
Shizuoka Cancer Center /ID# 251752
🇯🇵Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital /ID# 250319
🇯🇵Chuo-ku, Tokyo, Japan
Pusan National University Yangsan Hospital /ID# 248489
🇰🇷Yangsan-si, Gyeongsangnamdo, Korea, Republic of
Samsung Medical Center /ID# 248407
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kaohsiung Chang Gung Memorial Hospital /ID# 248143
🇨🇳Kaohsiung City, Kaohsiung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 248144
🇨🇳Kaohsiung, Taiwan
National Cheng Kung University Hospital /ID# 248142
🇨🇳Tainan, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 248145
🇨🇳Taoyuan City, Taiwan