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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07005102
Registration number
NCT07005102
Ethics application status
Date submitted
27/05/2025
Date registered
5/06/2025
Date last updated
9/09/2025
Titles & IDs
Public title
A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
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Scientific title
A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
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Secondary ID [1]
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2024-518586-10
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Secondary ID [2]
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M25-287
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Squamous Non-Small Cell Lung Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Standard of Care
Treatment: Drugs - Telisotuzumab Adizutecan
Treatment: Drugs - Osimertinib (Osi)
Experimental: Stage 1: Escalation Telisotuzumab Adizutecan with Osimertinib - Participants will receive increasing doses of telisotuzumab adizutecan with osimertinib (Osi), as part of the approximately 76 month study duration.
Experimental: Stage 1: Expansion Telisotuzumab Adizutecan Dose A with Osi - Participants will receive telisotuzumab adizutecan dose A with Osi, as part of the approximately 76 month study duration.
Experimental: Stage 1: Expansion Telisotuzumab Adizutecan Dose B with Osi - Participants will receive telisotuzumab adizutecan dose B with Osi, as part of the approximately 76 month study duration.
Experimental: Stage 1: Expansion Telisotuzumab Adizutecan Dose C with Osi - Participants will receive telisotuzumab adizutecan dose C with Osi, as part of the approximately 76 month study duration.
Experimental: Stage 1: Expansion Osi - Participants will receive Osi, as part of the approximately 76 month study duration.
Experimental: Stage 2: Standared of Care (SOC) Osi - Participants will receive Osi, as part of the approximately 76 month study duration.
Experimental: Stage 2: Telisotuzumab Adizutecan Optimized with Osi - Participants will receive the optimized dose of telisotuzumab adizutecan with Osi, as part of the approximately 76 month study duration.
Treatment: Drugs: Standard of Care
Standard of Care
Treatment: Drugs: Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Treatment: Drugs: Osimertinib (Osi)
Oral Tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 2: Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
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Assessment method [1]
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OR is defined as confirmed complete response (CR) or confirmed partial response (PR) per BICR based on RECIST version 1.1.
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Timepoint [1]
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Up to Approximately 76 Months
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Primary outcome [2]
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Phase 3: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.
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Assessment method [2]
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PFS is defined as the time from the participant's randomization date to the first occurrence of radiographic progression per BICR based on RECIST version 1.1 or death from any cause, whichever occurs earlier.
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Timepoint [2]
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Up to Approximately 76 Months
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Primary outcome [3]
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Number of Participants with Adverse Events (AEs)
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Assessment method [3]
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An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
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Timepoint [3]
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Up to Approximately 76 Months
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Secondary outcome [1]
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Phase 2: PFS based on BICR assessment per RECIST version 1.1.
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Assessment method [1]
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PFS is defined as the time from the participant's randomization date to the first occurrence of radiographic progression per BICR based on RECIST version 1.1 or death from any cause, whichever occurs earlier.
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Timepoint [1]
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Up to Approximately 76 Months
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Secondary outcome [2]
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Phase 2: Duration of response (DoR) based on BICR assessment per RECIST version 1.1.
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Assessment method [2]
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DOR is defined as the time from the first documented CR or PR per BICR to the first occurrence of radiographic progression per RECIST version 1.1 or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.
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Timepoint [2]
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Up to Approximately 76 Months
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Secondary outcome [3]
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Phase 2: Disease control rate (DC) based on BICR assessment per RECIST version 1.1.
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Assessment method [3]
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DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) for at least 12 weeks following randomization date based on RECIST version 1.1, as determined by the BICR.
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Timepoint [3]
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Up to Approximately 76 Months
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Secondary outcome [4]
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Phase 2: Overall Survival
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Assessment method [4]
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OS is defined as the time from participant's randomization date to the event of death from any cause.
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Timepoint [4]
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Up to Approximately 76 Months
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Secondary outcome [5]
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Phase 3: Overall Survival
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Assessment method [5]
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OS is defined as the time from participant's randomization date to the event of death from any cause.
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Timepoint [5]
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Up to Approximately 76 Months
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Secondary outcome [6]
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Phase 3: OR based on BICR assessment per RECIST version 1.1.
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Assessment method [6]
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OR is defined as confirmed CR or confirmed PR per BICR based on RECIST version 1.1.
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Timepoint [6]
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Up to Approximately 76 Months
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Secondary outcome [7]
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Phase 3: DoR based on BICR assessment per RECIST version 1.1.
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Assessment method [7]
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DOR is defined as the time from the first documented CR or PR per BICR to the first occurrence of radiographic progression per RECIST version 1.1 or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.
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Timepoint [7]
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Up to Approximately 76 Months
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Secondary outcome [8]
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Phase 3: DC based on BICR assessment per RECIST version 1.1.
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Assessment method [8]
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DC is defined as best overall response of confirmed CR or confirmed PR, or SD for at least 12 weeks following randomization date based on RECIST version 1.1, as determined by the BICR.
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Timepoint [8]
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Up to Approximately 76 Months
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Secondary outcome [9]
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Phase 3: Change from baseline at Week 12 in physical functioning as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
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Assessment method [9]
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The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).
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Timepoint [9]
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Up to Approximately 76 Months
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Secondary outcome [10]
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Phase 3: Change from baseline at Week 12 in key lung cancer symptoms as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13)
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Assessment method [10]
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The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication. Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much).
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Timepoint [10]
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Up to Approximately 76 Months
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Secondary outcome [11]
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Phase 3: Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30.
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Assessment method [11]
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The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).
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Timepoint [11]
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Up to Approximately 76 Months
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Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1.
* Must consent to provide recently obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met immunohistochemistry (IHC) testing and study stratification. c-Met IHC results are required prior to randomization.
* Must have at least one non-irradiated measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.
* Any toxicities from prior systemic anti-cancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level (except for alopecia [any grade] or Grade <= 2 peripheral neuropathy).
* Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan.
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
* Participants has leptomeningeal disease, or subject has spinal cord compression not definitively treated with surgery or radiation.
* History of any malignancy except for malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator, successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/08/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2031
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Actual
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Sample size
Target
694
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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The Queen Elizabeth Hospital /ID# 275719 - Woodville
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Recruitment postcode(s) [1]
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5011 - Woodville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Iowa
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Country [4]
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United States of America
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State/province [4]
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Nebraska
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Country [5]
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United States of America
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State/province [5]
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Nevada
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Country [6]
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Israel
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State/province [6]
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Tel Aviv
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Country [7]
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Israel
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State/province [7]
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Petah Tikva
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Country [8]
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Taiwan
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State/province [8]
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Kaohsiung City
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi), Osi alone, or standard of care (SOC) alone. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. Osi is a drug approved for the treatment of NSCLC. This study will be divided into two stages, in the first stage participants will receive increasing doses of telisotuzumab adizutecan with Osi. Participants will then be randomized into 4 groups called treatment arms where 3 groups will receive 1 of 3 optimized doses of telisotuzumab adizutecan from the dose escalation phase with Osi, or Osi alone. In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 694 adult participants with mCRC will be enrolled in the study in 200 sites worldwide. In Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. During dose optimization participants will receive OSi alone or with 1 of 3 optimized doses of telisotuzumab adizutecan. In stage 2 participnats will recieve the optimal dose of IV telisotuzumab adizutecanin with oral Osi tablet, or SOC. The study will run for a duration of approximately 76 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
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Trial website
https://clinicaltrials.gov/study/NCT07005102
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Country
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Phone
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844-663-3742
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
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Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07005102
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