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)
EU CTIS ID: 2022-500608-23-00
What this study is testing
To determine objective response rate (ORR) of telisotuzumab vedotin in previously untreated subjects with MET amplified non-squamous NSCLC.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects must have completed an informed consent.
- Subject must be an adult, at least 18 years old.
- Subject 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. Where confirmed as a local requirement, the central assay can only be utilized after IVDR certification is obtained.
- Subject must have histologically documented non-squamous adenocarcinoma NSCLC that is locally advanced or metastatic.
- Subject must have measurable disease per RECIST version 1.1.
- Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
You likely can't join if
- Subject must not have clinically significant condition(s) including but not limited to the following: 1) Clinically significant vascular disease, including: Myocardial infarction within 1 year or stroke within 6 months prior to first dose of study drug, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III – IV), cardiac arrhythmia (CTCAE Version 5 Grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities. 2) Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis. 3) Grade ≥ 2 edema or lymphedema. 4) Grade ≥ 2 ascites or pleural effusion. 5) Grade ≥ 2 neuropathy. 6) Active uncontrolled bacterial or viral infection.
- Subjects with alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy are not eligible. Subjects with other alterations that are candidates for available targeted therapy are not eligible.
- Subject must have no prior systemic therapy for locally advanced/metastatic NSCLC. 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. Subject 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.
- Subject must not have received prior c-Met-targeted antibodies.
- Subject must not have NSCLC that is eligible for treatment with curative intent.
- Subjects must not have a history of other malignancies except: 1) 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. 2) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3) Adequately treated carcinoma in situ without current evidence of disease.
See the full eligibility criteria
- Subjects must have completed an informed consent.
- Subject must be an adult, at least 18 years old.
- Subject 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. Where confirmed as a local requirement, the central assay can only be utilized after IVDR certification is obtained.
- Subject must have histologically documented non-squamous adenocarcinoma NSCLC that is locally advanced or metastatic.
- Subject must have measurable disease per RECIST version 1.1.
- Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Subjects with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and: 1) There is no evidence of progression of CNS metastases at least 2 weeks after definitive therapy. 2) 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.
- History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Subject must not have clinically significant condition(s) including but not limited to the following: 1) Clinically significant vascular disease, including: Myocardial infarction within 1 year or stroke within 6 months prior to first dose of study drug, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III – IV), cardiac arrhythmia (CTCAE Version 5 Grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities. 2) Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis. 3) Grade ≥ 2 edema or lymphedema. 4) Grade ≥ 2 ascites or pleural effusion. 5) Grade ≥ 2 neuropathy. 6) Active uncontrolled bacterial or viral infection.
- Subjects with alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy are not eligible. Subjects with other alterations that are candidates for available targeted therapy are not eligible.
- Subject must have no prior systemic therapy for locally advanced/metastatic NSCLC. 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. Subject 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.
- Subject must not have received prior c-Met-targeted antibodies.
- Subject must not have NSCLC that is eligible for treatment with curative intent.
- Subjects must not have a history of other malignancies except: 1) 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. 2) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3) Adequately treated carcinoma in situ without current evidence of disease.
- Subject must not 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.
- Subject must not have unresolved adverse events (AEs) ≥ Grade 2 from prior anticancer therapy, except for alopecia or anemia.
- Subject must not have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- Japan
- China
- Korea, Republic of
- Taiwan
- United Kingdom
- Turkey
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia; Japan; China; Korea, Republic of; Taiwan and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.