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Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein

Primary Purpose

Non-Small Cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Telisotuzumab Vedotin
Osimertinib
Cisplatin
Carboplatin
Pemetrexed
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, Telisotuzumab Vedotin, ABBV-399, Osimertinib, Cisplatin, Carboplatin, Pemetrexed, c-Met, NSCLC, Teliso-V, TeliMET NSCLC-03

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must have metastatic/locally advanced non-squamous NSCLC with documented epidermal growth factor receptor (EGFR) mutation del19 or L858R, with or without T790M mutation, and no identified EGFR mutations known to confer resistance to osimertinib (for instance C797S). Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. Must have measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1. Must have received one prior regimen in the metastatic setting, consisting of a third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKi) (for instance, osimertinib). Participant must have had one disease progression while on this third generation EGFR TKi. Prior-rechallenge with a third generation EGFR TKi is not allowed. Treatment with a first or second generation EGFR TKi immediately prior to the third generation EGFR TKi will not count as one prior regimen. Those who have received a third generation EGFR TKi as adjuvant therapy, and have progressed within 6 months of the last dose of treatment will be eligible (i.e., considered as having received a third generation EGFR TKi in the metastatic setting). Must be considered appropriate for platinum therapy based on the assessment of the treating physician. Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and: There is no evidence of progression of CNS metastases at least 4 weeks after definitive therapy. Participant is asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 4 weeks prior to first dose of telisotuzumab vedotin. There is no leptomeningeal seeding of the disease. History of prior radiation pneumonitis in the radiation field (fibrosis) is permitted. Exclusion Criteria: Have adenosquamous histology, nor sarcomatoid features. Alterations in ALK, ROS1, or BRAF that predict sensitivity to targeted therapies. Have small-cell histology. Have received prior chemotherapy in the metastatic setting. For the enrollment criterion, if a subject has received one to two cycles of platinum-based chemotherapy prior to starting a third generation EGFR TKi, without progression and while awaiting EGFR status results, it will not be counted as "prior platinum therapy." Those who have received platinum-based chemotherapy as adjuvant therapy, and have progressed within 6 months of the last dose will be counted as having received a prior platinum therapy in the metastatic setting. Have a history of other malignancies except those listed 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. 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) including but not limited to those listed in the protocol. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Telisotuzumab Vedotin and Osimertinib

    Standard of Care

    Arm Description

    Participants will receive telisotuzumab vedotin every 2 weeks in combination with osimertinib, until disease progression or unacceptable toxicity.

    Participants will receive standard of care chemotherapy (carboplatin/pemetrexed or cisplatin/pemetrexed as prescribed by the physician), until disease progression or unacceptable toxicity.

    Outcomes

    Primary Outcome Measures

    PFS in the Population of Participants with no Central Nervous System (CNS) Metastases at Baseline
    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 per ICR or death from any cause, whichever occurs earlier. Participants with no PFS event will be censored at the last evaluable radiographic assessment per ICR. Participants with no event and no evaluable post-baseline assessment will be censored at randomization.

    Secondary Outcome Measures

    PFS in the Overall Population
    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 per ICR or death from any cause, whichever occurs earlier.
    Overall Response (OR) in the Population of Participants with no CNS Metastases at Baseline
    OR (per ICR) is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per ICR based on RECIST v1.1.
    OR in the Overall Population
    OR (per ICR) is defined as participants achieving a best overall response of confirmed CR or confirmed PR per ICR based on RECIST v1.1.
    Duration of Response (DoR) in the Population of Participants with no CNS Metastases at Baseline
    DoR is defined for confirmed responders as the time from the initial response (CR or PR) per ICR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first.
    DoR in the Overall Population
    DoR is defined for confirmed responders as the time from the initial response (CR or PR) per ICR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first.
    Overall Survival (OS) in the Population of Participants with no CNS Metastases at Baseline
    OS is defined as the time from randomization to the event of death from any cause.
    OS in the Overall Population
    OS is defined as the time from randomization to the event of death from any cause.
    Change in Physical Functioning using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) in the Population of Participants with no CNS Metastases at Baseline
    The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30.2 The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). With the exception of 2 pain questions, which have dichotomous response categories (no or yes) and a free response if 'yes' is selected, all items on the QLQ-LC13 are scored on a 4-point Likert scale ranging from 1 (not at all) to (very much). The items have a 1-week recall period. All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts.
    Change in Physical Functioning using EORTC QLQ-LC13 in the Overall Population
    The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30.2 The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). With the exception of 2 pain questions, which have dichotomous response categories (no or yes) and a free response if 'yes' is selected, all items on the QLQ-LC13 are scored on a 4-point Likert scale ranging from 1 (not at all) to (very much). The items have a 1-week recall period. All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts.
    Change in Physical Functioning as Measured by the Physical Functioning Domain of the EORTC QLQ-C30 in the Population of Participants with no CNS Metastases at Baseline
    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.
    Change in Physical Functioning as Measured by the Physical Functioning Domain of the EORTC QLQ-C30 in the Overall Population
    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.
    Change in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 in the Population of Participants with no CNS Metastases at Baseline
    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.
    Change in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 in the Overall Population
    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.
    Percentage of Participants With Adverse Events (AEs)
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.

    Full Information

    First Posted
    October 17, 2023
    Last Updated
    October 17, 2023
    Sponsor
    AbbVie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06093503
    Brief Title
    Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein
    Official Title
    Phase 3, Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Combined With Osimertinib vs Platinum-Based Chemotherapy in Subjects With c-Met Overexpressing (OE) EGFR Mutant, Locally Advanced/Metastatic Non-Squamous NSCLC After a First Progression on Prior Third Generation EGFR TKi Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 31, 2024 (Anticipated)
    Primary Completion Date
    April 11, 2028 (Anticipated)
    Study Completion Date
    April 11, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. 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 assess how telisotuzumab vedotin in combination with osimertinib affects the disease state compared to standard of care in adult participants with locally advanced/metastatic non-squamous NSCLC that has a mutation in the epidermal growth factor receptor (EGFR) gene and that overexpresses the c-Met protein. Change in disease activity will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC that overexpresses the c-Met protein. Participants are randomly placed in one of the two groups to receive telisotuzumab vedotin and osimertinib or standard of care chemotherapy. Approximately 250 adult participants with locally advanced/metastatic non-squamous NSCLC that has a mutation in the EGFR gene and that overexpresses the c-Met protein will be enrolled in the study in approximately 180 sites worldwide. Participants will receive intravenous telisotuzumab vedotin every 2 weeks in combination with oral osimertinib tablets daily or standard of care chemotherapy (carboplatin/pemetrexed or cisplatin/pemetrexed as prescribed by the physician). Overall duration of the study is estimated to be approximately 47 months. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Small Cell Lung Cancer
    Keywords
    Non-Small Cell Lung Cancer, Telisotuzumab Vedotin, ABBV-399, Osimertinib, Cisplatin, Carboplatin, Pemetrexed, c-Met, NSCLC, Teliso-V, TeliMET NSCLC-03

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Telisotuzumab Vedotin and Osimertinib
    Arm Type
    Experimental
    Arm Description
    Participants will receive telisotuzumab vedotin every 2 weeks in combination with osimertinib, until disease progression or unacceptable toxicity.
    Arm Title
    Standard of Care
    Arm Type
    Experimental
    Arm Description
    Participants will receive standard of care chemotherapy (carboplatin/pemetrexed or cisplatin/pemetrexed as prescribed by the physician), until disease progression or unacceptable toxicity.
    Intervention Type
    Drug
    Intervention Name(s)
    Telisotuzumab Vedotin
    Other Intervention Name(s)
    ABBV-399
    Intervention Description
    Intravenous (IV) Infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Osimertinib
    Intervention Description
    Oral: Tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Intervention Description
    IV Infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Intervention Description
    IV Infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Pemetrexed
    Intervention Description
    IV Infusion
    Primary Outcome Measure Information:
    Title
    PFS in the Population of Participants with no Central Nervous System (CNS) Metastases at Baseline
    Description
    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 per ICR or death from any cause, whichever occurs earlier. Participants with no PFS event will be censored at the last evaluable radiographic assessment per ICR. Participants with no event and no evaluable post-baseline assessment will be censored at randomization.
    Time Frame
    Up to Approximately 41 Months
    Secondary Outcome Measure Information:
    Title
    PFS in the Overall Population
    Description
    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 per ICR or death from any cause, whichever occurs earlier.
    Time Frame
    Up to Approximately 41 Months
    Title
    Overall Response (OR) in the Population of Participants with no CNS Metastases at Baseline
    Description
    OR (per ICR) is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per ICR based on RECIST v1.1.
    Time Frame
    Up to Approximately 41 Months
    Title
    OR in the Overall Population
    Description
    OR (per ICR) is defined as participants achieving a best overall response of confirmed CR or confirmed PR per ICR based on RECIST v1.1.
    Time Frame
    Up to Approximately 41 Months
    Title
    Duration of Response (DoR) in the Population of Participants with no CNS Metastases at Baseline
    Description
    DoR is defined for confirmed responders as the time from the initial response (CR or PR) per ICR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first.
    Time Frame
    Up to Approximately 41 Months
    Title
    DoR in the Overall Population
    Description
    DoR is defined for confirmed responders as the time from the initial response (CR or PR) per ICR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first.
    Time Frame
    Up to Approximately 41 Months
    Title
    Overall Survival (OS) in the Population of Participants with no CNS Metastases at Baseline
    Description
    OS is defined as the time from randomization to the event of death from any cause.
    Time Frame
    Up to Approximately 41 Months
    Title
    OS in the Overall Population
    Description
    OS is defined as the time from randomization to the event of death from any cause.
    Time Frame
    Up to Approximately 41 Months
    Title
    Change in Physical Functioning using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) in the Population of Participants with no CNS Metastases at Baseline
    Description
    The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30.2 The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). With the exception of 2 pain questions, which have dichotomous response categories (no or yes) and a free response if 'yes' is selected, all items on the QLQ-LC13 are scored on a 4-point Likert scale ranging from 1 (not at all) to (very much). The items have a 1-week recall period. All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts.
    Time Frame
    Up to 41 Months
    Title
    Change in Physical Functioning using EORTC QLQ-LC13 in the Overall Population
    Description
    The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30.2 The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). With the exception of 2 pain questions, which have dichotomous response categories (no or yes) and a free response if 'yes' is selected, all items on the QLQ-LC13 are scored on a 4-point Likert scale ranging from 1 (not at all) to (very much). The items have a 1-week recall period. All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts.
    Time Frame
    Up to 41 Months
    Title
    Change in Physical Functioning as Measured by the Physical Functioning Domain of the EORTC QLQ-C30 in the Population of Participants with no CNS Metastases at Baseline
    Description
    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.
    Time Frame
    Up to 41 Months
    Title
    Change in Physical Functioning as Measured by the Physical Functioning Domain of the EORTC QLQ-C30 in the Overall Population
    Description
    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.
    Time Frame
    Up to 41 Months
    Title
    Change in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 in the Population of Participants with no CNS Metastases at Baseline
    Description
    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.
    Time Frame
    Up to 41 Months
    Title
    Change in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 in the Overall Population
    Description
    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.
    Time Frame
    Up to 41 Months
    Title
    Percentage of Participants With Adverse Events (AEs)
    Description
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
    Time Frame
    Up to 41 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must have metastatic/locally advanced non-squamous NSCLC with documented epidermal growth factor receptor (EGFR) mutation del19 or L858R, with or without T790M mutation, and no identified EGFR mutations known to confer resistance to osimertinib (for instance C797S). Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. Must have measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1. Must have received one prior regimen in the metastatic setting, consisting of a third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKi) (for instance, osimertinib). Participant must have had one disease progression while on this third generation EGFR TKi. Prior-rechallenge with a third generation EGFR TKi is not allowed. Treatment with a first or second generation EGFR TKi immediately prior to the third generation EGFR TKi will not count as one prior regimen. Those who have received a third generation EGFR TKi as adjuvant therapy, and have progressed within 6 months of the last dose of treatment will be eligible (i.e., considered as having received a third generation EGFR TKi in the metastatic setting). Must be considered appropriate for platinum therapy based on the assessment of the treating physician. Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and: There is no evidence of progression of CNS metastases at least 4 weeks after definitive therapy. Participant is asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 4 weeks prior to first dose of telisotuzumab vedotin. There is no leptomeningeal seeding of the disease. History of prior radiation pneumonitis in the radiation field (fibrosis) is permitted. Exclusion Criteria: Have adenosquamous histology, nor sarcomatoid features. Alterations in ALK, ROS1, or BRAF that predict sensitivity to targeted therapies. Have small-cell histology. Have received prior chemotherapy in the metastatic setting. For the enrollment criterion, if a subject has received one to two cycles of platinum-based chemotherapy prior to starting a third generation EGFR TKi, without progression and while awaiting EGFR status results, it will not be counted as "prior platinum therapy." Those who have received platinum-based chemotherapy as adjuvant therapy, and have progressed within 6 months of the last dose will be counted as having received a prior platinum therapy in the metastatic setting. Have a history of other malignancies except those listed 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. 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) including but not limited to those listed in the protocol. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ABBVIE CALL CENTER
    Phone
    844-663-3742
    Email
    abbvieclinicaltrials@abbvie.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ABBVIE INC.
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
    IPD Sharing Time Frame
    For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
    IPD Sharing Access Criteria
    Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
    IPD Sharing URL
    https://vivli.org/ourmember/abbvie/
    Links:
    URL
    https://www.abbvieclinicaltrials.com/study/?id=M22-142
    Description
    Related Info

    Learn more about this trial

    Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein

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