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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03735121




Registration number
NCT03735121
Ethics application status
Date submitted
7/11/2018
Date registered
8/11/2018
Date last updated
16/10/2024

Titles & IDs
Public title
A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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
Secondary ID [1] 0 0
2018-002328-18
Secondary ID [2] 0 0
BP40657
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1
Timepoint [1] 0 0
Pre-dose on Day 1 of Cycle 2 (Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2)
Primary outcome [2] 0 0
Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1
Timepoint [2] 0 0
Predose on Day 1 of Cycle 2 (Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2)
Primary outcome [3] 0 0
Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1
Timepoint [3] 0 0
From start of dosing up to Day 21 in Cycle 1 (Cycle length= 21 days)
Secondary outcome [1] 0 0
Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Part 1: Percentage of Participants With Adverse Events (AEs)
Timepoint [5] 0 0
Baseline up to data cutoff date for primary analysis, April 26, 2022 (up to approximately 17 months)
Secondary outcome [6] 0 0
Part 2: Percentage of Participants With AEs
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1
Timepoint [7] 0 0
Cycle 1 (Cycle length=21 days)
Secondary outcome [8] 0 0
Part 2: Model Predicted Ctrough at Steady State (Cthrough,ss) of Atezolizumab
Timepoint [8] 0 0
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)
Secondary outcome [9] 0 0
Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab
Timepoint [9] 0 0
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)
Secondary outcome [10] 0 0
Part 2: Objective Response Rate (ORR)
Timepoint [10] 0 0
From treatment initiation until disease progression or loss of clinical benefit (Up to approximately 72 months).
Secondary outcome [11] 0 0
Part 2: Progression-Free Survival (PFS)
Timepoint [11] 0 0
From study start to the first occurrence of disease progression or death from any cause, whichever occurs first (Up to approximately 72 months).
Secondary outcome [12] 0 0
Part 2: Overall Survival (OS)
Timepoint [12] 0 0
From study start to death from any cause (Up to approximately 72 months)
Secondary outcome [13] 0 0
Part 2: Duration of Response (DOR)
Timepoint [13] 0 0
From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 72 months)
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
From Day 1 of Cycles 1-6 and then every other cycle up to treatment discontinuation visit (Up to approximately 72 months)
Secondary outcome [15] 0 0
Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ)
Timepoint [15] 0 0
Day 1 Cycle 3 or at treatment discontinuation visit (Up to approximately 72 months)
Secondary outcome [16] 0 0
Part 2: Overall Patient-reported AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57
Timepoint [16] 0 0
Day 1 of Cycles 1-6 and then every other cycle up to treatment discontinuation visit (Up to approximately 72 months)
Secondary outcome [17] 0 0
Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration
Timepoint [17] 0 0
From first dose of atezolizumab up to treatment discontinuation visit (Up to approximately 72 Months).
Secondary outcome [18] 0 0
Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration Relative to the Prevalence of ADAs at Baseline
Timepoint [18] 0 0
From first dose of atezolizumab up to treatment discontinuation visit (Up to approximately 72 Months)
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
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)
Secondary outcome [20] 0 0
Part 2: Convenience, Ease of Administration, and Overall Satisfaction With Atezolizumab SC Assessed Using HCP Subcutaneous Perspective Questionnaire
Timepoint [20] 0 0
After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 72 months)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
438
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
La Rioja
Country [3] 0 0
Argentina
State/province [3] 0 0
Salta
Country [4] 0 0
Brazil
State/province [4] 0 0
RJ
Country [5] 0 0
Brazil
State/province [5] 0 0
RS
Country [6] 0 0
Brazil
State/province [6] 0 0
SP
Country [7] 0 0
Chile
State/province [7] 0 0
Recoleta
Country [8] 0 0
Chile
State/province [8] 0 0
Temuco
Country [9] 0 0
Chile
State/province [9] 0 0
Vina Del Mar
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Changchun
Country [12] 0 0
China
State/province [12] 0 0
Chengdu City
Country [13] 0 0
China
State/province [13] 0 0
Guangzhou
Country [14] 0 0
China
State/province [14] 0 0
Hangzhou City
Country [15] 0 0
China
State/province [15] 0 0
Harbin
Country [16] 0 0
China
State/province [16] 0 0
Jinan City
Country [17] 0 0
China
State/province [17] 0 0
Tianjin
Country [18] 0 0
China
State/province [18] 0 0
Wuhan
Country [19] 0 0
China
State/province [19] 0 0
Zhengzhou
Country [20] 0 0
Costa Rica
State/province [20] 0 0
San José
Country [21] 0 0
France
State/province [21] 0 0
Marseille
Country [22] 0 0
France
State/province [22] 0 0
Saint Herblain
Country [23] 0 0
Greece
State/province [23] 0 0
Asvestochori
Country [24] 0 0
Greece
State/province [24] 0 0
Athens
Country [25] 0 0
Guatemala
State/province [25] 0 0
Ciudad de Guatemala
Country [26] 0 0
Guatemala
State/province [26] 0 0
Guatemala City
Country [27] 0 0
Guatemala
State/province [27] 0 0
Guatemala
Country [28] 0 0
Hungary
State/province [28] 0 0
Matrahaza
Country [29] 0 0
Hungary
State/province [29] 0 0
Székesfehérvár
Country [30] 0 0
Hungary
State/province [30] 0 0
Törökbálint
Country [31] 0 0
Italy
State/province [31] 0 0
Lombardia
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul
Country [33] 0 0
Latvia
State/province [33] 0 0
Riga
Country [34] 0 0
Mexico
State/province [34] 0 0
Mexico CITY (federal District)
Country [35] 0 0
Mexico
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Queretaro
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New Zealand
State/province [36] 0 0
Auckland
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New Zealand
State/province [37] 0 0
Christchurch
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New Zealand
State/province [38] 0 0
Hamilton
Country [39] 0 0
New Zealand
State/province [39] 0 0
Tauranga
Country [40] 0 0
Peru
State/province [40] 0 0
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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Poland
State/province [44] 0 0
Otwock
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Poland
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Warszawa
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Russian Federation
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Mordovija
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Russian Federation
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Moskovskaja Oblast
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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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Pretoria
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South Africa
State/province [54] 0 0
Sandton
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
Madrid
Country [57] 0 0
Thailand
State/province [57] 0 0
Bangkok
Country [58] 0 0
Thailand
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Chanthaburi
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Thailand
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ChiangMai
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Thailand
State/province [60] 0 0
Hat Yai
Country [61] 0 0
Thailand
State/province [61] 0 0
Khonkaen
Country [62] 0 0
Thailand
State/province [62] 0 0
Muang,Udonthani
Country [63] 0 0
Turkey
State/province [63] 0 0
Ankara
Country [64] 0 0
Turkey
State/province [64] 0 0
Istanbul
Country [65] 0 0
Turkey
State/province [65] 0 0
Izmir
Country [66] 0 0
Turkey
State/province [66] 0 0
Sihhiye/Ankara
Country [67] 0 0
Ukraine
State/province [67] 0 0
Katerynoslav Governorate
Country [68] 0 0
Ukraine
State/province [68] 0 0
Kharkiv Governorate
Country [69] 0 0
Ukraine
State/province [69] 0 0
Ivano-Frankivsk
Country [70] 0 0
Ukraine
State/province [70] 0 0
Sumy
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Birmingham
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03735121