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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05388669
Registration number
NCT05388669
Ethics application status
Date submitted
19/05/2022
Date registered
24/05/2022
Titles & IDs
Public title
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
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Scientific title
A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy
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Secondary ID [1]
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2022-000525-25
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Secondary ID [2]
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CR109211
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Universal Trial Number (UTN)
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Trial acronym
PALOMA-3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Non-small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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0
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0
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Lung - Non small cell
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Cancer
0
0
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Lazertinib
Treatment: Drugs - Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
Treatment: Drugs - Amivantamab Intravenous
Experimental: Arm A: Lazertinib with Amivantamab SC-CF - Lazertinib 240 milligrams (mg) will be administered orally once daily. Participants will receive amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 mg/ 2240 mg depending on the body weight by manual injection. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the long-term extension (LTE) Phase.
Experimental: Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion - Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the LTE Phase.
Treatment: Drugs: Lazertinib
Lazertinib tablets will be administered orally.
Treatment: Drugs: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
Amivantamab injection will be administered subcutaneously by manual injection.
Treatment: Drugs: Amivantamab Intravenous
Amivantamab will be administered by IV infusion.
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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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For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1
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Assessment method [1]
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Ctrough is the observed serum concentration of Amivantamab at steady state on Cycle 4 Day 1 immediately prior to the next drug administration.
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Timepoint [1]
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Cycle 4 Day 1 (28 days cycle)
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Primary outcome [2]
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For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1
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Assessment method [2]
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Ctrough is the observed serum concentration of Amivantamab at pre-dose on Cycle 2 Day 1 immediately prior to the next drug administration.
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Timepoint [2]
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Cycle 2 Day 1 (28 days cycle)
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Primary outcome [3]
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Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab of Cycle 2
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Assessment method [3]
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AUC(Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15, will be reported.
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Timepoint [3]
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Cycle 2 Day 1 to Cycle 2 Day 15 (28 days cycle)
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants who achieve either a CR or PR as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1).
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Timepoint [1]
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Up to 1 year 11 months
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Secondary outcome [2]
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Progression-Free Survival (PFS)
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Assessment method [2]
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PFS is defined as the time from randomization until the date of objective disease progression or death, whichever comes first, based on RECIST version 1.1.
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Timepoint [2]
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Up to 1 year 11 months
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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The DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR.
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Timepoint [3]
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0
Up to 1 year 11 months
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Secondary outcome [4]
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Time to Response (TTR)
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Assessment method [4]
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Time to response (that is time to first response) is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression and subsequent anticancer therapy, as defined by BICR using RECIST version 1.1., for participants who have PR or CR as their best response.
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Timepoint [4]
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0
Up to 1 year 11 months
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Secondary outcome [5]
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Number of Participants With Adverse Events (AEs)
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Assessment method [5]
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. This outcome includes participants continuing in the LTE Phase for whom, after the primary analysis, data were collected until a discontinuation criterion is met, or until 3 years after local marketing authorization is obtained.
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Timepoint [5]
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Up to 4 year 11 months
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Secondary outcome [6]
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Number of Participants with AEs by Severity
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Assessment method [6]
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Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. This outcome includes participants continuing in the LTE Phase for whom, after the primary analysis, data were collected until a discontinuation criterion is met, or until 3 years after local marketing authorization is obtained.
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Timepoint [6]
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Up to 4 year 11 months
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Secondary outcome [7]
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Number of Participants with Clinical Laboratory Abnormalities
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Assessment method [7]
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Number of participants with clinical laboratory abnormalities (serum Chemistry, hematology, coagulation, and urinalysis) will be reported. This outcome includes participants continuing in the LTE Phase for whom, after the primary analysis, data were collected until a discontinuation criterion is met, or until 3 years after local marketing authorization is obtained.
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Timepoint [7]
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Up to 4 year 11 months
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Secondary outcome [8]
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Number of Participants with Clinical Laboratory Abnormalities by Severity
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Assessment method [8]
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Number of participants with clinical laboratory abnormalities by severity (serum Chemistry, hematology, coagulation, and urinalysis) will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. This outcome includes participants continuing in the LTE Phase for whom, after the primary analysis, data were collected until a discontinuation criterion is met, or until 3 years after local marketing authorization is obtained.
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Timepoint [8]
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Up to 4 year 11 months
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Secondary outcome [9]
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Number of Participants Infusion Related Reactions (IRRs)
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Assessment method [9]
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Number of participants with IRRs will be reported.
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Timepoint [9]
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Up to 1 year 11 months
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Secondary outcome [10]
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Number of Participants with Infusion Related Reactions (IRRs) by Severity
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Assessment method [10]
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Number of participants with IRRs by severity will be reported.
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Timepoint [10]
0
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Up to 1 year 11 months
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Secondary outcome [11]
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For All Regions Other Than the EU and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1
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Assessment method [11]
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The Ctrough is the observed serum concentration of Amivantamab at pre-dose on Cycle 2 Day 1 immediately prior to the next drug administration.
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Timepoint [11]
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Cycle 2 Day 1 (28 days cycle)
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Secondary outcome [12]
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For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1
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Assessment method [12]
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The Ctrough is the observed serum concentration of Amivantamab at steady state on Cycle 4 Day 1 immediately prior to the next drug administration.
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Timepoint [12]
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Cycle 4 Day 1 (28 days cycle)
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Secondary outcome [13]
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Model-Predicted Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab at Steady State of Cycle 4
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Assessment method [13]
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Model-predicted AUC(Day 1-15) defined as area under the concentration time curve from Cycle 4 Day 1 to Day 15, will be reported.
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Timepoint [13]
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From Cycle 4 Day 1 to Cycle 4 Day 15 (28 days cycle)
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Secondary outcome [14]
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Percentage of Participants with Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies
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Assessment method [14]
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Percentage of participants with presence of anti-amivantamab antibody anti-rHuPH20 antibodies will be reported.
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Timepoint [14]
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Up to 1 year 11 months
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Secondary outcome [15]
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Percentage of Participants with Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ)
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Assessment method [15]
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Percentage of participants with cancer therapy satisfaction in will be assessed using the modified TASQ. The modified TASQ is an 11-item questionnaire measuring the impact of each mode of treatment administration on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction.
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Timepoint [15]
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Up to 1 year 11 months
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Secondary outcome [16]
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Change from Baseline in TASQ as Assessed Over Time
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Assessment method [16]
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Change from baseline in TASQ as assessed Over time will be reported. The modified TASQ is an 11-item questionnaire measuring the impact of each mode of treatment administration on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction.
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Timepoint [16]
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Up to 1 year 11 months
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Secondary outcome [17]
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Participant Chair Time
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Assessment method [17]
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Participant chair time will be assessed by time and motion analysis.
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Timepoint [17]
0
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Up to 1 year 11 months
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Secondary outcome [18]
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Duration of Treatment Administration
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Assessment method [18]
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Duration of treatment administration will be assessed by time and motion analysis.
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Timepoint [18]
0
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Up to 1 year 11 months
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Secondary outcome [19]
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Active HCP Time For Drug Preparation, Treatment Administration and Posttreatment Monitoring
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Assessment method [19]
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Active health care professional time for drug preparation, treatment administration, and posttreatment monitoring will be assessed by time and motion analysis.
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Timepoint [19]
0
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Up to 1 year 11 months
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Secondary outcome [20]
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Participant Time in Treatment Room
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Assessment method [20]
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Participant time in treatment room will be assessed by time and motion analysis.
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Timepoint [20]
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Up to 1 year 11 months
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Eligibility
Key inclusion criteria
* Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an Food and Drug Administration (FDA)-approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United Started [US]) or an accredited local laboratory (sites outside of the US)
* Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKI]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease
* Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1
* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
* Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade less than or equal to (<=) 2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement)
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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
* Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors
* Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization
* Participant has symptomatic or progressive brain metastases
* Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
* Participant has uncontrolled tumor-related pain
* Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
5/08/2022
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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
9/01/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
418
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Cancer Research SA - Adelaide
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Recruitment hospital [2]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [4]
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St John of God Hospital Murdoch - Murdoch
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Recruitment hospital [5]
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Westmead Hospital - Westmead
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Recruitment hospital [6]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment postcode(s) [4]
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6150 - Murdoch
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Recruitment postcode(s) [5]
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2145 - Westmead
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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0
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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Colorado
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United States of America
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State/province [3]
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Florida
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United States of America
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State/province [4]
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Kansas
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Country [5]
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0
United States of America
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State/province [5]
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Michigan
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United States of America
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State/province [6]
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New Jersey
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United States of America
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State/province [7]
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New York
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0
United States of America
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State/province [8]
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Oregon
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0
United States of America
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State/province [9]
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Pennsylvania
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Country [10]
0
0
United States of America
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State/province [10]
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South Carolina
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Country [11]
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0
United States of America
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State/province [11]
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Virginia
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Country [12]
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0
Argentina
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State/province [12]
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0
Buenos Aires
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Country [13]
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Argentina
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State/province [13]
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Caba
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Country [14]
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Argentina
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State/province [14]
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Ciudad Autonoma de Buenos Aires
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Country [15]
0
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Argentina
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State/province [15]
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Cordoba
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Country [16]
0
0
Argentina
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State/province [16]
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Viedma
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0
0
Brazil
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State/province [17]
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0
Barretos
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Country [18]
0
0
Brazil
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State/province [18]
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Belo Horizonte
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0
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Brazil
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State/province [19]
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Curitiba
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0
0
Brazil
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State/province [20]
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Florianopolis
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0
0
Brazil
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State/province [21]
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Ipatinga
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0
0
Brazil
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State/province [22]
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Pelotas
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0
Brazil
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State/province [23]
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0
Porto Alegre
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0
0
Brazil
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State/province [24]
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0
Rio de Janeiro
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0
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Brazil
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State/province [25]
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Salvador
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0
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Brazil
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Santo Andre
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Brazil
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State/province [27]
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0
Sao Paulo
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0
Brazil
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State/province [28]
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0
São Paulo
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0
0
Canada
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State/province [29]
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0
Ontario
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Country [30]
0
0
China
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State/province [30]
0
0
Beijing
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Country [31]
0
0
China
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State/province [31]
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0
Changchun
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0
0
China
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State/province [32]
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0
Changzhou
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0
0
China
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State/province [33]
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0
Chengdu
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0
0
China
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State/province [34]
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0
Chongqing
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0
0
China
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State/province [35]
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0
ChongQing
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0
0
China
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State/province [36]
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0
Ganzhou
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0
0
China
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State/province [37]
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0
Guang Zhou
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0
0
China
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State/province [38]
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0
Guangzhou
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0
0
China
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State/province [39]
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0
Hang Zhou
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Country [40]
0
0
China
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State/province [40]
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0
Hangzhou
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Country [41]
0
0
China
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State/province [41]
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0
Harbin
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0
0
China
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0
Huizhou
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0
0
China
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State/province [43]
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0
Liuzhou
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Country [44]
0
0
China
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State/province [44]
0
0
Nanchong
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Country [45]
0
0
China
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State/province [45]
0
0
Shanghai
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Country [46]
0
0
China
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State/province [46]
0
0
Shen Zhen Shi
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Country [47]
0
0
China
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State/province [47]
0
0
Shenyang
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Country [48]
0
0
China
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State/province [48]
0
0
Shenzhen
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Country [49]
0
0
China
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State/province [49]
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0
Tianjin
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Country [50]
0
0
China
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State/province [50]
0
0
Wuhan
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Country [51]
0
0
China
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State/province [51]
0
0
XI An
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Country [52]
0
0
China
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State/province [52]
0
0
Xiangyang
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Country [53]
0
0
China
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State/province [53]
0
0
Yantai
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Country [54]
0
0
China
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State/province [54]
0
0
Zhengzhou
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Country [55]
0
0
France
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State/province [55]
0
0
La Tronche
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Country [56]
0
0
France
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State/province [56]
0
0
Lille
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Country [57]
0
0
France
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State/province [57]
0
0
Limoges
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Country [58]
0
0
France
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State/province [58]
0
0
Marseille Cedex 20
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Country [59]
0
0
Germany
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State/province [59]
0
0
Berlin
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Country [60]
0
0
Germany
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State/province [60]
0
0
Georgsmarienhütte
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Country [61]
0
0
Germany
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State/province [61]
0
0
Giessen
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Country [62]
0
0
Germany
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State/province [62]
0
0
Münster
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Country [63]
0
0
Germany
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State/province [63]
0
0
Recklinghausen
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Country [64]
0
0
Germany
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State/province [64]
0
0
Weinsberg
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Country [65]
0
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petah-Tikva
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Israel
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Ramat Gan
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Italy
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Bari
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Italy
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Italy
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Milano
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Italy
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Orbassano
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Italy
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Padova
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Italy
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Ravenna
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Italy
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Roma
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Italy
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Rome
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Italy
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Rozzano
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Japan
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Chuo Ku
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Himeji
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Japan
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Hirakata
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Japan
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Kanagawa
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Japan
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Kurashiki
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Kurume
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Japan
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Okayama
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Osaka City
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Sapporo-shi
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Shizuoka
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Tokyo
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Toyoake
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Wakayama
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Japan
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Yamaguchi
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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Kuching
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Petaling Jaya
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Bydgoszcz
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Otwock
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Braga
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Portugal
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Lisboa
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Portugal
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Senhora da Hora,
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A Coruna
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Alicante
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Barcelona
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Córdoba
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Las Palmas de Gran Canaria
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Lugo
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Madrid
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Majadahonda
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Palma de Mallorca
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Sevilla
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Valencia
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Changhua
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Taiwan
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Kaohsiung
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Tainan
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Taipei
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Taoyuan
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Bangkok
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Thailand
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Chiangmai
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Turkey
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Adana
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Ankara
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Edirne
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Istanbul
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Izmir
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Turkey
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Samsun
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United Kingdom
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Birmingham
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United Kingdom
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London
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.
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Trial website
https://clinicaltrials.gov/study/NCT05388669
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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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0
Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Contact person for public queries
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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?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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When will data be available (start and end dates)?
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Available to whom?
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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://www.janssen.com/clinical-trials/transparency
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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/NCT05388669