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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/NCT03735121
Registration number
NCT03735121
Ethics application status
Date submitted
7/11/2018
Date registered
8/11/2018
Date last updated
25/03/2024
Titles & IDs
Public title
A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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Scientific title
A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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Secondary ID [1]
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2018-002328-18
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Secondary ID [2]
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BP40657
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-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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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - rHuPH20
Experimental: Atezolizumab (Part 2) - Atezolizumab
Experimental: Cohort 1: Atezolizumab+rHuPH20 (Part 1) - Atezolizumab+recombinant human hyaluronidase (rHuPH20), followed by Atezolizumab
Experimental: Cohort 2: Atezolizumab+rHuPH20 (Part 1) - Atezolizumab+rHuPH20, followed by Atezolizumab
Experimental: Cohort 3: Atezolizumab+rHuPH20(Part 1) - Atezolizumab+rHuPH20, followed by Atezolizumab
Experimental: Atezolizumab + rHuPH20 (Part 2) - Atezolizumab + rHuPH20
Treatment: Drugs: Atezolizumab
Atezolizumab will be administered as per the schedule specified in arm or cohort.
Treatment: Drugs: rHuPH20
rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
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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: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1
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Assessment method [1]
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Timepoint [1]
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Pre-dose on Day 1 of Cycle 2 (Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2)
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Primary outcome [2]
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Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1
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Assessment method [2]
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Timepoint [2]
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Predose on Day 1 of Cycle 2 (Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2)
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Primary outcome [3]
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Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1
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Assessment method [3]
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Timepoint [3]
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From start of dosing up to Day 21 in Cycle 1 (Cycle length= 21 days)
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Secondary outcome [1]
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Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab
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Assessment method [1]
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Timepoint [1]
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Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2)
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Secondary outcome [2]
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Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab
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Assessment method [2]
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Timepoint [2]
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Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2)
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Secondary outcome [3]
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Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab
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Assessment method [3]
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Timepoint [3]
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Predose and up to 21 days post dose in Cycle 1 for cohorts 1 and 3 and from predose up to 14 days post last dose in Cycle 1 for cohort 2 (Cycle length= 21 days for cohorts 1 and 3 and 14 days for cohort 2)
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Secondary outcome [4]
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Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration
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Assessment method [4]
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Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2. Day=D; Cycle=C.
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Timepoint [4]
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Cohort 1: Pre&postdose:D1 &postdose: D3,8 of C1; Cohort 2: Pre&postdose: D1 of C1,3 & postdose: D3,8 of C1, Predose: D1 of C2; Cohort 3: Pre& postdose: D1 of C1,2 & postdose: D3,8 of C1, D2,4& 9 of C2& pre dose:D1 of C3
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Secondary outcome [5]
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Part 1: Percentage 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 participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 5.0 (NCI-CTCAE, v5.0).
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Timepoint [5]
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Baseline up to data cutoff date for primary analysis, April 26, 2022 (up to approximately 17 months)
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Secondary outcome [6]
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Part 2: Percentage of Participants With AEs
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Assessment method [6]
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 5.0 (NCI-CTCAE, v5.0).
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Timepoint [6]
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From signing of informed consent form (ICF) until 30 days after last dose of study drug administration in Part 2 (Up to approximately 72 months)
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Secondary outcome [7]
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Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1
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Assessment method [7]
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Timepoint [7]
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Cycle 1 (Cycle length=21 days)
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Secondary outcome [8]
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Part 2: Model Predicted Ctrough at Steady State (Cthrough,ss) of Atezolizumab
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Assessment method [8]
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1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo.
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Timepoint [8]
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Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months)
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Secondary outcome [9]
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Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab
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Assessment method [9]
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1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo
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Timepoint [9]
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Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months)
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Secondary outcome [10]
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Part 2: Objective Response Rate (ORR)
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Assessment method [10]
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ORR is defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters in the absence of CR.
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Timepoint [10]
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From treatment initiation until disease progression or loss of clinical benefit (Up to approximately 72 months).
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Secondary outcome [11]
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Part 2: Progression-Free Survival (PFS)
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Assessment method [11]
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PFS is defined as the time from study start to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or or death from any cause (whichever occurs first).
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Timepoint [11]
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From study start to the first occurrence of disease progression or death from any cause, whichever occurs first (Up to approximately 72 months).
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Secondary outcome [12]
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Part 2: Overall Survival (OS)
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Assessment method [12]
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OS defined as the time from study entry to death from any cause.
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Timepoint [12]
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From study start to death from any cause (Up to approximately 72 months)
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Secondary outcome [13]
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Part 2: Duration of Response (DOR)
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Assessment method [13]
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DOR is defined as the time from first occurrence of a documented objective response to disease progression as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. Objective response is defined as the percentage of participants having a CR or PR as determined by investigator assessment of radiographic disease per RECIST v1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters in the absence of CR.
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Timepoint [13]
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From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 72 months)
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Secondary outcome [14]
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Part 2: Functioning and Global Health Status Over Time, as Assessed by European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL)57
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Assessment method [14]
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EORTC IL57 questionnaire has10 items and covers 3 scales: physical functioning (PF), role functioning (RF) & global health status/quality of life (GHS/QoL) & 1 item from EORTC Item Library. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1="Not at all" to 4="Very much") for physical and role functioning & a 7-point scale (where 1="Very poor" to 7="Excellent") for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 =best possible score. Higher score = better outcome.
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Timepoint [14]
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From Day 1 of Cycles 1-6 and then every other cycle up to treatment discontinuation visit (Up to approximately 72 months)
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Secondary outcome [15]
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Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ)
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Assessment method [15]
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Modified SWT scale of the CTSQ consist of seven items that measures seven domains related to satisfaction with cancer therapy. These include worthwhile, difficulty, benefits, feelings about side effects, form of therapy, overall satisfaction, and if participants would choose the therapy taking everything into consideration. Each domain is rated on a 5-point scale, with 1 representing the worst response and 5 representing the best response, except in the case of one reverse-scored item. mean of the items are linearly transformed to obtain scores from 0-100, where 100 =best possible score Higher scores are associated with higher satisfaction.
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Timepoint [15]
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Day 1 Cycle 3 or at treatment discontinuation visit (Up to approximately 72 months)
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Secondary outcome [16]
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Part 2: Overall Patient-reported AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57
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Assessment method [16]
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The overall patient-reported AE burden was assessed using the a single item from the EORTC IL57 questionnaire i.e To what extent have you been troubled with side-effects from your treatment?. The questions is answered on a 4-point Likert scale where 1="Not at all" to 4="Very much". Higher scores indicates greater AE burden.
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Timepoint [16]
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Day 1 of Cycles 1-6 and then every other cycle up to treatment discontinuation visit (Up to approximately 72 months)
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Secondary outcome [17]
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Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration
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Assessment method [17]
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Timepoint [17]
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From first dose of atezolizumab up to treatment discontinuation visit (Up to approximately 72 Months).
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Secondary outcome [18]
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Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration Relative to the Prevalence of ADAs at Baseline
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Assessment method [18]
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Timepoint [18]
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From first dose of atezolizumab up to treatment discontinuation visit (Up to approximately 72 Months)
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Secondary outcome [19]
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Part 2: Convenience, Potential Time Savings, and Overall Satisfaction With Atezolizumab SC Compared With Atezolizumab IV as Assessed by the Health Care Professional (HCP) SC Versus IV Perspective Questionnaire
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Assessment method [19]
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The HCP Subcutaneous Versus IV Perspective Questionnaire consists of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction.
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Timepoint [19]
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After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 72 months)
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Secondary outcome [20]
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Part 2: Convenience, Ease of Administration, and Overall Satisfaction With Atezolizumab SC Assessed Using HCP Subcutaneous Perspective Questionnaire
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Assessment method [20]
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The HCP Subcutaneous Perspective Questionnaire consists of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction.
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Timepoint [20]
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After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 72 months)
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Eligibility
Key inclusion criteria
- Histologically or cytologically documented locally advanced or metastatic NSCLC
- Prior platinum-containing regimen or disease recurrence = 6 months since prior
platinum-based adjuvant/neoadjuvant regimen.
- Measurable disease as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy =12 weeks
- Adequate hematologic and end-organ function
Additional Inclusion Criteria (Part 2 Only) • Availability of tissue and known epidermal
growth factor receptor (EGFR) status
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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
- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases
- Uncontrolled or symptomatic hypercalcemia
- Pregnancy or breastfeeding
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- Severe infection = 4 weeks
- Treatment with therapeutic oral or IV antibiotics = 2 weeks prior to study treatment
- Significant cardiovascular disease
- Prior allogeneic stem cell or solid organ transplantation
- Treatment with a live, attenuated vaccine = 4 weeks
- Treatment with systemic immunostimulatory agents = 4 weeks or 5 half-lives of the drug
- Treatment with systemic immunosuppressive medication = 2 weeks
Additional Exclusion Criteria (Part 2 Only)
• Tested tumor programmed death-ligand-1 (PD-L1) expression status with an intention to
treat the patient if positive
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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
Other
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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
14/12/2018
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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
31/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
438
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Argentina
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State/province [2]
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La Rioja
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Argentina
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Salta
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Brazil
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RJ
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Brazil
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RS
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Brazil
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SP
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Chile
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Recoleta
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Chile
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Temuco
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Chile
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Vina Del Mar
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China
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Beijing
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China
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Changchun
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China
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Chengdu City
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China
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Guangzhou
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China
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Hangzhou City
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China
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Harbin
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China
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Jinan City
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China
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Tianjin
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China
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Wuhan
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China
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Zhengzhou
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Costa Rica
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San José
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France
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Marseille
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France
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Saint Herblain
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Greece
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Asvestochori
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Greece
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Athens
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Guatemala
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Ciudad de Guatemala
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Guatemala
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Guatemala City
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Guatemala
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Guatemala
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Hungary
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Matrahaza
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Hungary
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Székesfehérvár
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Hungary
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Törökbálint
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Italy
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Lombardia
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Mexico
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Mexico CITY (federal District)
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Mexico
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Queretaro
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Hamilton
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New Zealand
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Tauranga
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Peru
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Arequipa
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Peru
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Lima
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Poland
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Grudzi?dz
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Poland
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Lodz
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Otwock
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Poland
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Russian Federation
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Mordovija
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Russian Federation
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Russian Federation
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Niznij Novgorod
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Russian Federation
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Kaluga
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Russian Federation
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Murmansk
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Russian Federation
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Samara
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South Africa
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Cape Town
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South Africa
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KwaZulu Natal
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South Africa
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Pretoria
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South Africa
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Sandton
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Spain
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Barcelona
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Spain
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Madrid
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Thailand
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Bangkok
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Thailand
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Chanthaburi
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Thailand
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State/province [60]
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ChiangMai
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Country [61]
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Thailand
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State/province [61]
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Hat Yai
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Country [62]
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Thailand
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State/province [62]
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Khonkaen
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Country [63]
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Thailand
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State/province [63]
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Muang,Udonthani
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Country [64]
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Turkey
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State/province [64]
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Ankara
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Country [65]
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Turkey
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State/province [65]
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Istanbul
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Country [66]
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Turkey
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State/province [66]
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Izmir
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Country [67]
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Turkey
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State/province [67]
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Sihhiye/Ankara
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Country [68]
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Ukraine
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State/province [68]
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Katerynoslav Governorate
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Country [69]
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Ukraine
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State/province [69]
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Kharkiv Governorate
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Country [70]
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Ukraine
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Ivano-Frankivsk
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Country [71]
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Ukraine
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Sumy
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Country [72]
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United Kingdom
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State/province [72]
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Birmingham
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Country [73]
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United Kingdom
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Leeds
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Summary
Brief summary
This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab
subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally
advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer
immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is
comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to
identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part
2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields
drug exposure that is comparable to that of atezolizumab IV.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03735121
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03735121
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