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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/NCT03739710
Registration number
NCT03739710
Ethics application status
Date submitted
9/11/2018
Date registered
14/11/2018
Date last updated
29/06/2023
Titles & IDs
Public title
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)
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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]
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0
2018-001316-29
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Secondary ID [2]
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205801
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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
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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
Treatment: Drugs - Ipilimumab
Treatment: Drugs - GSK4428859A
Treatment: Drugs - Dostarlimab
Treatment: Drugs - GSK6097608
Experimental: Part 1: Participants receiving feladilimab and ipilimumab -
Experimental: Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug -
Experimental: Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug plus GSK6097608 -
Active Comparator: Part 2: Participants receiving SoC: docetaxel -
Experimental: Part 2: Participants receiving feladilimab and docetaxel -
Treatment: Drugs: Docetaxel
Docetaxel will be administered.
Treatment: Drugs: Feladilimab
Feladilimab will be administered.
Treatment: Drugs: Ipilimumab
Ipilimumab will be administered.
Treatment: Drugs: GSK4428859A
GSK4428859A/EOS884448 will be administered.
Treatment: Drugs: Dostarlimab
Dostarlimab will be administered.
Treatment: Drugs: GSK6097608
GSK6097608 will be administered.
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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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Part 1: Number of participants with any adverse events (AEs) and serious adverse events (SAEs)
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Assessment method [1]
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Timepoint [1]
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Up to 2 years
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Primary outcome [2]
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Part 1: Number of participants with dose limiting toxicity (DLT)
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Assessment method [2]
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Timepoint [2]
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Up to 2 years
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Primary outcome [3]
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Part 1: Number of participants with clinically significant changes in vital signs, physical examination and laboratory parameters
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Assessment method [3]
0
0
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Timepoint [3]
0
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Up to 2 years
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Primary outcome [4]
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Part 1: Number of participants requiring dose modifications
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Assessment method [4]
0
0
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Timepoint [4]
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Up to 2 years
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Primary outcome [5]
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Part 2: Overall survival
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Assessment method [5]
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Overall survival will be calculated as time from randomization to death.
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Timepoint [5]
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Up to 3 years
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Secondary outcome [1]
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Part 1: Objective response rate
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Assessment method [1]
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Objective response rate will be calculated as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. It is defined as the percentage of participants with a best overall confirmed complete response (CR) or partial response (PR) at any time as per disease-specific criteria.
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Timepoint [1]
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Up to 2 years
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Secondary outcome [2]
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Part 1: Disease control rate (DCR)
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Assessment method [2]
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DCR is defined as the percentage of participants with a best overall confirmed CR, PR or stable disease (SD) at any time as per disease-specific criteria.
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Timepoint [2]
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Up to 2 years
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Secondary outcome [3]
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Part 1: Maximum observed concentration (Cmax) and Minimum observed concentration (Cmin) of feladilimab
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Assessment method [3]
0
0
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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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Part 1: Cmax and Cmin of ipilimumab
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Assessment method [4]
0
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Timepoint [4]
0
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Up to 2 years
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Secondary outcome [5]
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Part 1: Cmax and Cmin of GSK4428859A/EOS884448/belrestotug
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Assessment method [5]
0
0
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Timepoint [5]
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Up to 2 years
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Secondary outcome [6]
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Part 1: Cmax and Cmin of dostarlimab
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Assessment method [6]
0
0
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Timepoint [6]
0
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Up to 2 years
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Secondary outcome [7]
0
0
Part 1: Cmax and Cmin of GSK6097608
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Assessment method [7]
0
0
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Timepoint [7]
0
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Up to 2 years
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Secondary outcome [8]
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Part 2: Survival rate at 12 and 18 months
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Assessment method [8]
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Milestone survival rate of participants treated with experimental regimens versus SoC therapy.
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Timepoint [8]
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At 12 and 18 months
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Secondary outcome [9]
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Part 2: Number of participants with CR, Partial response (PR), Stable disease (SD) and Progressive disease (PD)
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Assessment method [9]
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CR, PR, SD and PD will be evaluated as per RECIST version 1.1 criteria.
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Timepoint [9]
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Up to 2 years
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Secondary outcome [10]
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Part 2: Progression-free survival (PFS)
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Assessment method [10]
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PFS is defined as time from the date of randomization to the date of disease progression or death whichever occurs earlier.
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Timepoint [10]
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Up to 2 years
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Secondary outcome [11]
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Part 2: Objective response rate (ORR)
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Assessment method [11]
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ORR is defined as the percentage of participants with a confirmed CR or PR at any time per RECIST version 1.1 criteria.
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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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Part 2: Duration of response (DOR)
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Assessment method [12]
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DOR is defined as the first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria.
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Timepoint [12]
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Up to 2 years
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Secondary outcome [13]
0
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Part 2: DCR
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Assessment method [13]
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DCR is defined as the percentage of participants with a best overall confirmed CR, PR or SD at any time as per disease-specific criteria.
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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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Part 2: Number of participants with immune-based (i) iCR, iPR, unconfirmed progressive disease (iUPD), confirmed progressive disease (iCPD), and iSD
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Assessment method [14]
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Number of participants with iCR, iPR, iUPD, iCPD and iSD per modified RECIST 1.1 for immune-based therapeutics (iRECIST) criteria.
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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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Part 2: Progression-free survival (iPFS)
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Assessment method [15]
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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.
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Timepoint [15]
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Up to 2 years
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Secondary outcome [16]
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Part 2: Objective response rate (iORR)
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Assessment method [16]
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iORR is defined as the percentage of participants with a confirmed CR or PR at any time per iRECIST criteria.
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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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Part 2: Duration of response (iDOR)
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Assessment method [17]
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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.
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Timepoint [17]
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Up to 2 years
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Secondary outcome [18]
0
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Part 2: 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 [18]
0
0
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Timepoint [18]
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Up to 2 years
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Secondary outcome [19]
0
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Part 2: Number of participants with clinically significant changes in vital signs, physical examination and laboratory parameters
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Assessment method [19]
0
0
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Timepoint [19]
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Up to 2 years
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Secondary outcome [20]
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Part 2: Cmax and Cmin for SoC (docetaxel)
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Assessment method [20]
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0
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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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Part 2: Cmax and Cmin for feladilimab
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Assessment method [21]
0
0
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Timepoint [21]
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Up to 2 years
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Secondary outcome [22]
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Part 2: Number of participants with positive anti-drug antibodies (ADA) against docetaxel
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Assessment method [22]
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0
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Timepoint [22]
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Up to 2 years
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Secondary outcome [23]
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Part 2: Number of participants with positive ADA against feladilimab
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Assessment method [23]
0
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Timepoint [23]
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Up to 2.5 years
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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. History of myocarditis of any grade during a previous treatment with
immunotherapy
3. 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
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
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
8/07/2025
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Actual
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Sample size
Target
185
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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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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United States of America
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Missouri
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New York
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United States of America
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North Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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Canada
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Alberta
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Canada
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Ontario
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France
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Bordeaux Cedex
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France
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Caen Cedex 9
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France
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Nantes cedex 1
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France
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Paris Cedex 05
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France
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Paris
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France
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Villejuif Cedex
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Toscana
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Korea, Republic of
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Cheongju-si, Chungcheongbuk-do
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Maastricht
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Poland
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Lodz
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Poland
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Poznan
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Poland
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Warszawa
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Romania
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Bucharest
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Romania
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Craiova
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Romania
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Floresti
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Romania
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Otopeni
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Romania
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Timisoara
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Russian Federation
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Chelyabinsk
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Russian Federation
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Saint-Petersburg
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Spain
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Badajoz
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Santander
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Spain
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Sevilla
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Sweden
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Solna
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Sweden
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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]
0
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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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0
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will compare the clinical activity of novel regimens (in combination or as single
agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be
conducted in two parts. Part 1 is an open-label, optional, non-randomized part based on
safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to generate
additional data to qualify novel regimens for the randomized study. Part 2 is a randomized,
Phase II open-label part comparing the efficacy and safety of these novel regimens with SoC.
Drug name mentioned as GSK4428859A (belrestotug) and EOS884448 are interchangeable for the
same compound and will be referred to as GSK4428859A/EOS884448/belrestotug.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03739710
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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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US GSK Clinical Trials Call Center
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877-379-3718
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[email protected]
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03739710
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