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 approximately 1.5 years ORR was 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 as assessed by ICR.
- Secondary Outcome Measures
Name Time Method Duration of Response (DoR) Up to approximately 1.5 years DoR was 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 approximately 1.5 years DCR was 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 approximately 1.5 years PFS was 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 approximately 1.5 years OS was defined as the time from participant's first dose of study drug to the event of death from any cause.
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32 The cough item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32 The pain in chest item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32 The dyspnea item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.
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). Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32 The Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 was reported on a scale of 0 to 100, with higher scores indicating better global health status/functioning and a positive change from baseline indicating improvement.
Trial Locations
- Locations (29)
Monash Health - Monash Medical Centre /ID# 247679
🇦🇺Clayton, Victoria, Australia
Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671
🇺🇸Los Alamitos, California, United States
Valley Medical Center /ID# 251880
🇺🇸Renton, Washington, United States
CHU Lille - Hôpital Albert Calmette /ID# 246263
🇫🇷Lille, Hauts-de-France, France
Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 246267
🇫🇷Bron, Rhone, France
Centre Jean Perrin /ID# 246268
🇫🇷Clermont-Ferrand, France
Asklepios Fachkliniken Muenchen-Gauting /ID# 248082
🇩🇪Gauting, Germany
Meir Medical Center /ID# 243208
🇮🇱Kfar Saba, Central District, Israel
Rambam Health Care Campus /ID# 246781
🇮🇱Haifa, H_efa, Israel
Hadassah Medical Center-Hebrew University /ID# 243298
🇮🇱Jerusalem, Jerusalem, Israel
Scroll for more (19 remaining)Monash Health - Monash Medical Centre /ID# 247679🇦🇺Clayton, Victoria, Australia