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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05553808
Registration number
NCT05553808
Ethics application status
Date submitted
21/09/2022
Date registered
23/09/2022
Date last updated
19/01/2023
Titles & IDs
Public title
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 1
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Scientific title
A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants
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Secondary ID [1]
0
0
2018-001316-29
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Secondary ID [2]
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0
205801-001
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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:
Neoplasms
0
0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Docetaxel
Treatment: Drugs - Feladilimab
Active Comparator: Docetaxel -
Experimental: Feladilimab plus Docetaxel -
Treatment: Drugs: Docetaxel
Docetaxel was administered as IV infusion.
Treatment: Drugs: Feladilimab
Feladilimab was administered as IV infusion.
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Intervention code [1]
0
0
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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Overall Survival
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Assessment method [1]
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Overall survival was calculated as time from randomization to death. Confidence Intervals estimated using the Brookmeyer Crowley method.
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Timepoint [1]
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Up to 2 years
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Secondary outcome [1]
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Kaplan-Meier Estimates of Overall Survival at 12 and 18 Months
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Assessment method [1]
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Overall survival was defined as the time between date of randomization and death due to any cause. Kaplan-Meier estimates of the percentage of participants who died at each time point was calculated. Confidence Intervals estimated using the Brookmeyer Crowley method.
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Timepoint [1]
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Month 12 and 18
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Secondary outcome [2]
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Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable
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Assessment method [2]
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CR, PR, SD and PD will be evaluated as per RECIST version 1.1 criteria. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
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Timepoint [2]
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0
Up to 2 years
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Secondary outcome [3]
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Kaplan-Meier Estimates of Progression-Free Survival (PFS)
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Assessment method [3]
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PFS is defined as time from the date of randomization to the date of disease progression as per RECIST v1.1. or death whichever occurs earlier. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. Confidence Intervals estimated using the Brookmeyer Crowley method.
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Timepoint [3]
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Up to 2 years
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Secondary outcome [4]
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Objective Response Rate
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Assessment method [4]
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ORR was calculated as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
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Timepoint [4]
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Up to 2 years
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Secondary outcome [5]
0
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Kaplan-Meier Estimates of Duration of Response (DOR) in Participants With Objective Response
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Assessment method [5]
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DOR is defined as the time for first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Confidence Intervals estimated using the Brookmeyer Crowley method.
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Timepoint [5]
0
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Up to 2 years
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Secondary outcome [6]
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Disease Control Rate (DCR)
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Assessment method [6]
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DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =>12 weeks as per RECIST v1.1. Complete Response (CR) was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
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Timepoint [6]
0
0
Up to 2 years
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Secondary outcome [7]
0
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Number of Participants With iRECIST Complete Response (iCR), Partial Response (iPR), Unconfirmed Progressive Disease (iUPD), Confirmed Progressive Disease (iCPD), Stable Disease (iSD) or Not Evaluable
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Assessment method [7]
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Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST was used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed and NE: not evaluable.
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Timepoint [7]
0
0
Up to 2 years
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Secondary outcome [8]
0
0
Kaplan-Meier Estimates of iRECIST Progression-free Survival (iPFS)
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Assessment method [8]
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iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm. Confidence Intervals estimated using the Brookmeyer Crowley method.
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Timepoint [8]
0
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Up to 2 years
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Secondary outcome [9]
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iRECIST Objective Response Rate (iORR)
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Assessment method [9]
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iORR is defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
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Timepoint [9]
0
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Up to 2 years
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Secondary outcome [10]
0
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Kaplan-Meier Estimates of iRECIST Duration of Response (iDOR) in Participants With Objective Response
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Assessment method [10]
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iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Confidence Intervals estimated using the Brookmeyer Crowley method.
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Timepoint [10]
0
0
Up to 2 years
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Secondary outcome [11]
0
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Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals
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Assessment method [11]
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An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. AESI are considered to be Infusion Related Reactions (IRRs) and those of potential immunologic etiology.
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Timepoint [11]
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Up to 2 years
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Secondary outcome [12]
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Number of Participants With Maximum Grade Increase in Clinical Chemistry Parameters at Worst Case Post-Baseline
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Assessment method [12]
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Blood samples were collected for assessment of the clinical chemistry parameters. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Number of participants with clinical chemistry results by maximum grade increase (Increase to Grade 3 or Increase to Grade 4) are presented.
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Timepoint [12]
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Up to 2 years
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Secondary outcome [13]
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Number of Participants With Maximum Grade Increase in Hematology Parameters at Worst Case Post-Baseline
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Assessment method [13]
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Blood samples were collected for assessment of the hematology parameters. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Number of participants with Hematology results by maximum grade increase (Increase to Grade 3 or Increase to Grade 4) are presented.
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Timepoint [13]
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Up to 2 years
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Secondary outcome [14]
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Number of Participants With Maximum Grade Increase in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure) Parameters at Worst Case Post-Baseline
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Assessment method [14]
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Blood Pressure was measured after 5 minutes of rest and was taken in the same position throughout the study. Laboratory grades were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE. Number of participants with vital signs results by maximum grade increase (Increase to Grade 2 or Increase to Grade 3) are presented.
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Timepoint [14]
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Up to 2 years
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Secondary outcome [15]
0
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Number of Participants With Vital Signs (Temperature) Parameter Results at Worst Case Post-Baseline
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Assessment method [15]
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Body temperature was measured after 5 minutes of rest. Results are presented in the following categories: Decrease to <=35 Degrees Celsius, Change to Normal or No Change and Increase to >=38 Degrees Celsius.
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Timepoint [15]
0
0
Up to 2 years
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Secondary outcome [16]
0
0
Number of Participants With Vital Signs (Pulse Rate) Parameter Results at Worst Case Post-Baseline
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Assessment method [16]
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Pulse Rate was measured after 5 minutes of rest. Results are presented in the following categories: Decrease to <50 beats per minute, Change to Normal or No Change and Increase to >120 beats per minute.
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Timepoint [16]
0
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Up to 2 years
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Secondary outcome [17]
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Minimum Observed Concentration (CmIn) of Feladilimab
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Assessment method [17]
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Blood samples were collected for assessment of the pharmacokinetic parameters.
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Timepoint [17]
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Week 1
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Secondary outcome [18]
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Maximum Observed Concentration (Cmax) of Feladilimab
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Assessment method [18]
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Blood samples were collected for assessment of the pharmacokinetic parameters.
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Timepoint [18]
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Week 1, Week 13 and Week 25
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Secondary outcome [19]
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Maximum Observed Concentration (Cmax) of Docetaxel
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Assessment method [19]
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Blood samples were collected for assessment of the pharmacokinetic parameters.
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Timepoint [19]
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Week 1, Week 4, Week 7, Week 10, Week 13, Week 16, Week 19 and Week 22
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Secondary outcome [20]
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Number of Participants With Positive Anti-drug Antibodies (ADA) Against Docetaxel
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Assessment method [20]
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Timepoint [20]
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Up to 2 years
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Secondary outcome [21]
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Number of Participants With Positive ADA Against Feladilimab
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Assessment method [21]
0
0
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Timepoint [21]
0
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Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 37, 49, 61 and 73
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Eligibility
Key inclusion criteria
- Participants capable of giving signed informed consent/assent.
- Male or female, aged 18 years or older at the time consent is obtained. Participants
in Korea must be age 19 years or older at the time consent is obtained.
- Participants with histologically or cytologically confirmed diagnosis of NSCLC
(squamous or non-squamous) and
a) Documented disease progression based on radiographic imaging, during or after a
maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent,
Stage IIIb/Stage IIIc/Stage IV or metastatic disease. Two components of treatment must
have been received in the same line or as separate lines of therapy: i) No more than
or less than 1 line of platinum-containing chemotherapy regimen, and ii) No more than
or less than 1 line of Programmed cell death ligand 1 (PD[L]1) monoclonal antibody
(mAb) containing regimen.
b) Participants with known BRAF molecular alterations must have had disease
progression after receiving the locally available SoC treatment for the molecular
alteration.
c) Participants who received prior anti-PD(L)1 therapy must fulfill the following
requirements: i) Have achieved a CR, PR or SD and subsequently had disease progression
(per RECIST 1.1 criteria) either on or after completing PD(L)1 therapy ii) Have not
progressed or recurred within the first 12 weeks of PD(L)1 therapy, either clinically
or per RECIST 1.1 criteria
- Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
- A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time
of study entry is mandatory. Although a fresh tumor tissue sample obtained during
screening is preferred, archival tumor specimen is acceptable.
- Adequate organ function as defined in the protocol.
- A male participant must agree to use a highly effective contraception during the
treatment period and for at least 120 days after the last dose of study treatment and
refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant, not
breastfeeding, and at least 1 of the following conditions apply:
i) Not a woman of childbearing potential (WOCBP) or ii) A WOCBP who agrees to follow
the contraceptive guidance during the treatment period and for at least 120 days after
the last dose of study treatment.
- Life expectancy of at least 12 weeks.
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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
- Participants who received prior treatment with the following therapies (calculation is
based on date of last therapy to date of first dose of study treatment):
1. Docetaxel at any time.
2. Any of the investigational agents being tested in the current study.
3. Systemic approved or investigational anticancer therapy within 30 days or 5
half-lives of the drug, whichever is shorter. At least 14 days must have elapsed
between the last dose of prior anticancer agent and the first dose of study drug
is administered.
4. Prior radiation therapy: permissible if at least one non-irradiated measurable
lesion is available for assessment per RECIST version 1.1 or if a solitary
measurable lesion was irradiated, objective progression is documented. A wash out
of at least 2 weeks before start of study drug for radiation of any intended use
is required.
- Received greater than (>)2 prior lines of therapy for NSCLC, including participants
with BRAF molecular alternations.
- Invasive malignancy or history of invasive malignancy other than disease under study
within the last 2 years, except
- Any other invasive malignancy for which the participant was definitively treated,
has been disease-free for at least 2 years and in the opinion of the principal
investigator and GlaxoSmithKline Medical Monitor will not affect the evaluation
of the effects of the study treatment on the currently targeted malignancy, may
be included in this clinical trial.
- Curatively treated non-melanoma skin cancer or successfully treated in situ
carcinoma.
- Carcinomatous meningitis (regardless of clinical status) and uncontrolled or
symptomatic Central nervous system (CNS) metastases.
- Major surgery less than or equal to (<=) 28 days of first dose of study treatment.
- Autoimmune disease (current or history) or syndrome that required systemic treatment
within the past 2 years. Replacement therapies which include physiological doses of
corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency)
are not considered systemic treatments.
- Receiving systemic steroids (>10 milligrams [mg]) oral prednisone or equivalent) or
other immunosuppressive agents within 7 days prior to first dose of study treatment.
- Prior allogeneic/autologous bone marrow or solid organ transplantation.
- Receipt of any live vaccine within 30 days prior to first dose of study treatment.
- Toxicity from previous anticancer treatment that includes:
1. Greater than or equal to (>=) Grade 3 toxicity considered related to prior
immunotherapy and that led to treatment discontinuation.
2. Toxicity related to prior treatment that has not resolved to <= Grade 1 (except
alopecia, hearing loss, endocrinopathy managed with replacement therapy, and
peripheral neuropathy which must be <= Grade 2).
- History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for past-
pneumonitis exclusion only if steroids were required for treatment), interstitial lung
disease, or organizing pneumonia.
- Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural
or pericardial effusions.
- Recent history (within the past 6 months) of gastrointestinal obstruction that
required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal
abscess.
- History or evidence of cardiac abnormalities within the 6 months prior to enrollment
which include
1. Serious, uncontrolled cardiac arrhythmia or clinically significant
electrocardiogram abnormalities including second degree (Type II) or third degree
atrioventricular block.
2. Cardiomyopathy, myocardial infarction, acute coronary syndromes (including
unstable angina pectoris), coronary angioplasty, stenting or bypass grafting.
3. Symptomatic pericarditis.
- Current unstable liver or biliary disease per investigator assessment defined by the
presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or
gastric varices, persistent jaundice, or cirrhosis.
- Active infection requiring systemic therapy <=7 days prior to first dose of study
treatment.
- Participants with known human immunodeficiency virus infection.
- Participants with history of severe hypersensitivity to mAb or hypersensitivity to any
of the study treatment(s) or their excipients.
- Participants requiring ongoing therapy with a medication that is a strong inhibitor or
inducer of the cytochrome P 3A4 (CYP3A4) enzymes.
- Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric
disorder, or other condition that could interfere with participant's safety, obtaining
informed consent, or compliance to the study procedures in the opinion of the
investigator.
- Pregnant or lactating female participants.
- Participant who is currently participating in or has participated in a study of an
investigational device within 4 weeks prior to the first dose of study treatment.
- Participants with presence of hepatitis B surface antigen (HBsAg) at screening or
within 3 months prior to first dose of study intervention.
- Participants with positive hepatitis C antibody test result at screening or within 3
months prior to first dose of study intervention.
- Participants with positive hepatitis C ribonucleic acid (RNA) test result at screening
or within 3 months prior to first dose of study treatment.
- Receipt of transfusion of blood products (including platelets or red blood cells) or
administration of colony-stimulating factors (including granulocyte colony stimulating
factor [G-CSF], granulocyte-macrophage colony-stimulating factor, and recombinant
erythropoietin) within 14 days before the first dose of study intervention.
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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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
24/01/2019
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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
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Actual
23/09/2021
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Sample size
Target
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Accrual to date
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Final
105
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Missouri
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Tennessee
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Texas
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Country [4]
0
0
Canada
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State/province [4]
0
0
Ontario
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Country [5]
0
0
France
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State/province [5]
0
0
Bordeaux Cedex
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Country [6]
0
0
France
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State/province [6]
0
0
Caen Cedex 9
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Country [7]
0
0
France
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State/province [7]
0
0
Nantes cedex 1
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Country [8]
0
0
France
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State/province [8]
0
0
Paris Cedex 05
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Country [9]
0
0
France
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State/province [9]
0
0
Paris
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Country [10]
0
0
France
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State/province [10]
0
0
Villejuif Cedex
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Country [11]
0
0
Germany
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State/province [11]
0
0
Bayern
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Country [12]
0
0
Germany
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State/province [12]
0
0
Hessen
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Country [13]
0
0
Germany
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State/province [13]
0
0
Sachsen
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Country [14]
0
0
Germany
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State/province [14]
0
0
Schleswig-Holstein
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Country [15]
0
0
Germany
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State/province [15]
0
0
Berlin
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Country [16]
0
0
Italy
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State/province [16]
0
0
Emilia-Romagna
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Country [17]
0
0
Italy
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State/province [17]
0
0
Lombardia
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Country [18]
0
0
Italy
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State/province [18]
0
0
Piemonte
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Country [19]
0
0
Korea, Republic of
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State/province [19]
0
0
Cheongju-si
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Country [20]
0
0
Korea, Republic of
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State/province [20]
0
0
Gyeonggi-do
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Country [21]
0
0
Korea, Republic of
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State/province [21]
0
0
Seongnam
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Country [22]
0
0
Korea, Republic of
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State/province [22]
0
0
Seoul
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Country [23]
0
0
Netherlands
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State/province [23]
0
0
Maastricht
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Country [24]
0
0
Poland
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State/province [24]
0
0
Lodz
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Country [25]
0
0
Poland
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State/province [25]
0
0
Poznan
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Country [26]
0
0
Poland
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State/province [26]
0
0
Warszawa
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Country [27]
0
0
Romania
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State/province [27]
0
0
Bucharest
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Country [28]
0
0
Romania
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State/province [28]
0
0
Craiova
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Country [29]
0
0
Romania
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State/province [29]
0
0
Floresti
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Country [30]
0
0
Romania
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State/province [30]
0
0
Otopeni
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Country [31]
0
0
Romania
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State/province [31]
0
0
Timisoara
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Country [32]
0
0
Russian Federation
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State/province [32]
0
0
Chelyabinsk
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Country [33]
0
0
Russian Federation
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State/province [33]
0
0
Saint-Petersburg
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Country [34]
0
0
Spain
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State/province [34]
0
0
Barcelona
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Country [35]
0
0
Spain
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State/province [35]
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Madrid
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Country [36]
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Spain
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State/province [36]
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Santander
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Country [37]
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Spain
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State/province [37]
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Sevilla
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Country [38]
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Sweden
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State/province [38]
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Uppsala
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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iTeos Belgium SA
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Address [1]
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Ethics approval
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Summary
Brief summary
This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study has assessed the clinical activity of novel regimen (Feladilimab plus Docetaxel) with SOC (Docetaxel) in participants with NSCLC.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05553808
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/ct2/show/NCT05553808
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