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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/NCT02031458




Registration number
NCT02031458
Ethics application status
Date submitted
16/12/2013
Date registered
9/01/2014
Date last updated
6/01/2020

Titles & IDs
Public title
A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Scientific title
A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With PD-L1-Positive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2013-003330-32
Secondary ID [2] 0 0
GO28754
Universal Trial Number (UTN)
Trial acronym
BIRCH
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

Experimental: Atezolizumab -


Treatment: Drugs: Atezolizumab
1200 mg IV every 3 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF)
Timepoint [1] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [1] 0 0
Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV)
Timepoint [1] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [2] 0 0
Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV
Timepoint [2] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [3] 0 0
Duration of Response (DOR) Assessed by IRF Per RECIST v1.1
Timepoint [3] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [4] 0 0
DOR as Assessed by INV Per RECIST v1.1
Timepoint [4] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [5] 0 0
DOR as Assessed by INV Per Modified RECIST
Timepoint [5] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [6] 0 0
Progression Free Survival (PFS) as Assessed by IRF Per RECIST v1.1
Timepoint [6] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [7] 0 0
PFS as Assessed by INV Per RECIST v1.1
Timepoint [7] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [8] 0 0
PFS as Assessed by INV Per Modified RECIST
Timepoint [8] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [9] 0 0
Overall Survival : Percentage of Participants Without Event (Death)
Timepoint [9] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [10] 0 0
Overall Survival : Median Time to Event (Death)
Timepoint [10] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [11] 0 0
Percentage of Participants Without an Event (Death) at 6 Months
Timepoint [11] 0 0
Month 6
Secondary outcome [12] 0 0
Percentage of Participants Without an Event (Death) at 12 Months
Timepoint [12] 0 0
Month 12
Secondary outcome [13] 0 0
PFS: Percentage of Participants Alive and Progression Free at 6 Months
Timepoint [13] 0 0
Month 6
Secondary outcome [14] 0 0
PFS: Percentage of Participants Alive and Progression Free at 12 Months
Timepoint [14] 0 0
Month 12
Secondary outcome [15] 0 0
Time in Response (TIR) as Assessed by INV Per RECIST v1.1
Timepoint [15] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [16] 0 0
TIR as Assessed by INV Per Modified RECIST
Timepoint [16] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [17] 0 0
TIR as Assessed by IRF Per RECIST v1.1
Timepoint [17] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [18] 0 0
Atezolizumab Serum Concentrations
Timepoint [18] 0 0
Pre-dose (hour 0) and 0.5 hours post dose on Cycle 1 Day 1 (Cycle length = 21days), Cycle 1 Days 2, 4, 8, 15, and 21, Cycle 2 Day 21, Cycle 3 Day 21, Cycle 7 Day 21
Secondary outcome [19] 0 0
Percentage of Participants With Positive Anti-Therapeutic Antibody (Anti-Atezolizumab Antibody) Status
Timepoint [19] 0 0
Baseline, post-baseline (up to 16 months)
Secondary outcome [20] 0 0
Percentage of Participants With Event (Disease Progression or Death) as Assessed by IRF Per RECIST v1.1
Timepoint [20] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [21] 0 0
Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per RECIST v1.1
Timepoint [21] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)
Secondary outcome [22] 0 0
Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per Modified RECIST v1.1
Timepoint [22] 0 0
Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)

Eligibility
Key inclusion criteria
- Adult participants greater than or equal to 18 years of age

- Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC

- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens

- PD-L1-positive tumor status as determined by an immunohistochemistry (IHC) assay based
on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by
a central laboratory

- Measurable disease, as defined by RECIST version 1.1

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3
weeks prior to initiation of study treatment; the following exception are allowed:

Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs)
approved for treatment of NSCLC discontinued >7 days prior to Cycle 1, Day 1

- Central nervous system (CNS) disease, including treated brain metastases

- Malignancies other than NSCLC within 5 years prior to randomization, with the
exception of those with negligible risk of metastases or death and treated with
expected curative outcome

- History of autoimmune disease

- History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced
pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT
scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted

- Active hepatitis B or hepatitis C

- Human Immunodeficiency virus (HIV) positive

- Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic
antibody or pathway-targeting agents

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/01/2019
Sample size
Target
Accrual to date
Final
667
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal North Shore Hospital; Oncology - St. Leonards
Recruitment hospital [2] 0 0
Princess AleXandra Hospital; Department of Medical Oncology - Woolloongabba
Recruitment hospital [3] 0 0
Austin Health - Heidelberg
Recruitment hospital [4] 0 0
Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital; Medical Oncology - Nedlands
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Belgium
State/province [23] 0 0
Bruxelles
Country [24] 0 0
Belgium
State/province [24] 0 0
Charleroi
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
Belgium
State/province [26] 0 0
Wilrijk
Country [27] 0 0
Bosnia and Herzegovina
State/province [27] 0 0
Banja Luka
Country [28] 0 0
Bosnia and Herzegovina
State/province [28] 0 0
Sarajevo
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Plovdiv
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Sofia
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Canada
State/province [31] 0 0
British Columbia
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Canada
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Ontario
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France
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Brest
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France
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Caen
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France
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Limoges
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France
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Lyon
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France
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Montpellier
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France
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Nantes
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France
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Strasbourg
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France
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Villejuif
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Georgia
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Tbilisi
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Germany
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Essen
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Germany
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Großhansdorf
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Germany
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Nürnberg
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Germany
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Oldenburg
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Germany
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Villingen-Schwenningen
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin
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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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Japan
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Fukuoka
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Tokyo
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Netherlands
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Amsterdam
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Netherlands
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Breda
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Netherlands
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Groningen
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Singapore
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Singapore
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Slovenia
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Ljubljana
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Spain
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Barcelona
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Spain
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Sevilla
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Switzerland
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Basel
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Switzerland
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Lausanne
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Switzerland
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St. Gallen
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Switzerland
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Zürich
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Turkey
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Ankara
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Turkey
State/province [70] 0 0
Izmir
Country [71] 0 0
Turkey
State/province [71] 0 0
Malatya
Country [72] 0 0
United Kingdom
State/province [72] 0 0
London
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Sutton

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

Ethics approval
Ethics application status

Summary
Brief summary
This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in
participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer
(NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3
weeks as long as participants are experiencing clinical benefit as assessed by the
investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration
attributed to disease progression.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02031458
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02031458