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A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
EU CTIS ID: 2023-505749-14-00
What this study is testing
The primary objective is to evaluate the efficacy of telisotuzumab vedotin compared with docetaxel on the basis of progression-free survival (PFS) and/or overall survival (OS) in the following nested populations: - Subjects with c-Met high overexpressing, EGFR wildtype, nonsquamous NSCLC and - All subjects with c-Met overexpressing, EGFR wildtype, non-squamous NSCLC.
- Therapeutic confirmatory (Phase III)
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
- Subject must have c-Met overexpressing NSCLC as assessed by an AbbVie designated IHC laboratory using the VENTANA MET (SP44) RxDx assay
- Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Subject must have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting. -Neoadjuvant and adjuvant systemic cytotoxic chemotherapy would count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
- Subject must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC: - Subjects WITHOUT an actionable gene alteration: subjects must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy). - Subjects WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): subjects must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy. - Subjects with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
- Subject must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
- Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels by an AbbVie designated IHC laboratory during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, fresh biopsy material may be submitted for reassessment of c-Met expression (see Operations Manual Section 3.7). - If a subject was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available
You likely can't join if
- Subject has adenosquamous or neuroendocrine histology, or sarcomatoid features
- Subjects with the following: - Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not required for eligibility for this protocol unless mandated by local regulatory authority or ethics committee/institutional review board. - Active hepatitis B virus (HBV) infection, defined by HBV DNA ≥ 500 IU/mL or hepatitis B surface antigen (HBsAG) positivity associated with HBV DNA ≥ 500 IU/mL. In subjects with known HBV infection, the presence of active infection must be tested locally. If HBV status is unknown, it must be tested locally at screening if required by local regulatory authority or ethics committee/institutional review board. - Active hepatitis C virus (HCV) infection, defined by HCV RNA positivity. Subjects cured of HCV infection may be included in the study. In subjects with known HCV infection, the presence of active infection must be tested locally. If HCV status is unknown, it must be tested locally at screening if required by local regulatory authority or ethics committee/institutional review board. - Uncontrolled autoimmune disease.
- Subject has clinically significant condition(s) including but not limited to the following: 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. - Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) > 450 msec; Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis; Grade ≥ 2 edema or lymphedema; Grade ≥ 2 ascites or pleural effusion; Grade ≥ 2 neuropathy; Active uncontrolled bacterial or viral infection; Active corneal disorder.
- Subject has a history of major immunologic reaction to any immunoglobulin G (IgG)-containing agent. Subject has hypersensitivity to docetaxel or polysorbate 80.
- Subjects have received any live vaccine within 30 days of the first dose of study drug.
- Treatment with any of the following therapies within the noted time intervals prior to randomisation: - Within 2 weeks (14 days): radiation therapy not involving the lungs. - Within 4 weeks (28 days) or 5 half-lives (whichever is shorter): systemic cytotoxic chemotherapy; small molecule targeted agents; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.
See the full eligibility criteria
Who can join
- Subject must have c-Met overexpressing NSCLC as assessed by an AbbVie designated IHC laboratory using the VENTANA MET (SP44) RxDx assay
- Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Subject must have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting. -Neoadjuvant and adjuvant systemic cytotoxic chemotherapy would count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
- Subject must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC: - Subjects WITHOUT an actionable gene alteration: subjects must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy). - Subjects WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): subjects must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy. - Subjects with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
- Subject must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
- Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels by an AbbVie designated IHC laboratory during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, fresh biopsy material may be submitted for reassessment of c-Met expression (see Operations Manual Section 3.7). - If a subject was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available
- Subject has adequate bone marrow, renal, and hepatic function
- Subject must have histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
- Subjects must have a known EGFR activating mutation status. - Subjects with EGFR activating mutations are not eligible.
- Subjects with actionable alterations in genes other than EGFR are eligible.
- Subject must have measurable disease per RECIST version 1.1.
What rules you out
- Subject has adenosquamous or neuroendocrine histology, or sarcomatoid features
- Subjects with the following: - Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not required for eligibility for this protocol unless mandated by local regulatory authority or ethics committee/institutional review board. - Active hepatitis B virus (HBV) infection, defined by HBV DNA ≥ 500 IU/mL or hepatitis B surface antigen (HBsAG) positivity associated with HBV DNA ≥ 500 IU/mL. In subjects with known HBV infection, the presence of active infection must be tested locally. If HBV status is unknown, it must be tested locally at screening if required by local regulatory authority or ethics committee/institutional review board. - Active hepatitis C virus (HCV) infection, defined by HCV RNA positivity. Subjects cured of HCV infection may be included in the study. In subjects with known HCV infection, the presence of active infection must be tested locally. If HCV status is unknown, it must be tested locally at screening if required by local regulatory authority or ethics committee/institutional review board. - Uncontrolled autoimmune disease.
- Subject has clinically significant condition(s) including but not limited to the following: 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. - Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) > 450 msec; Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis; Grade ≥ 2 edema or lymphedema; Grade ≥ 2 ascites or pleural effusion; Grade ≥ 2 neuropathy; Active uncontrolled bacterial or viral infection; Active corneal disorder.
- Subject has a history of major immunologic reaction to any immunoglobulin G (IgG)-containing agent. Subject has hypersensitivity to docetaxel or polysorbate 80.
- Subjects have received any live vaccine within 30 days of the first dose of study drug.
- Treatment with any of the following therapies within the noted time intervals prior to randomisation: - Within 2 weeks (14 days): radiation therapy not involving the lungs. - Within 4 weeks (28 days) or 5 half-lives (whichever is shorter): systemic cytotoxic chemotherapy; small molecule targeted agents; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.
- Subjects must not have had radiation therapy to the lung within 6 months prior to the first dose of study drug and until study drug is permanently discontinued.
- Subject has received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.
- Subject has received prior docetaxel therapy.
- Subjects with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy or drug therapy) is provided and: - They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg QD prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomisation; - There is no evidence of new, untreated CNS metastases or progressing CNS metastases after treatment; - There is no evidence of leptomeningeal disease.
- Subjects with a history of other malignancies except: 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. Additionally, subjects must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated carcinoma in situ without current evidence of disease.
- Subject with 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 CT scan.
- History of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.
- Subject with unresolved clinically significant AE ≥ Grade 2 from prior anticancer therapy, except for alopecia or anemia. Subjects with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
- Subject has had major surgery within 21 days prior to randomisation.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- South Africa
- Turkey
- Chile
- Argentina
- Australia
- United Kingdom
- Canada
- Switzerland
- Brazil
- Colombia
- Taiwan
- Israel
- New Zealand
- Ukraine
- Mexico
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 Korea, Republic of; South Africa; Turkey; Chile; Argentina; Australia and 10 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.