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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02366143




Registration number
NCT02366143
Ethics application status
Date submitted
12/02/2015
Date registered
19/02/2015
Date last updated
8/07/2020

Titles & IDs
Public title
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Scientific title
A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2014-003207-30
Secondary ID [2] 0 0
GO29436
Universal Trial Number (UTN)
Trial acronym
IMpower150
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel

Experimental: Arm A (Atezolizumab+Paclitaxel+Carboplatin) - Participants will receive intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.

Experimental: Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) - Participants will receive IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Active Comparator: Arm C (Bevacizumab+Paclitaxel+Carboplatin) - Participants will receive IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.


Treatment: Drugs: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.

Treatment: Drugs: Bevacizumab
Bevacizumab will be administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, or death.

Treatment: Drugs: Carboplatin
Carboplatin will be administered at area under the concentration-time curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.

Treatment: Drugs: Paclitaxel
Paclitaxel will be administered as IV infusion at a dose of 200 milligrams per square meter (mg/m^2) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Timepoint [1] 0 0
Baseline until disease progression or death, whichever occurs first (up to approximately 32 months)
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Baseline until death (up to approximately 32 months)
Secondary outcome [1] 0 0
PFS as Determined by the Independent Review Facility (IRF) Using RECIST v1.1
Timepoint [1] 0 0
Baseline until disease progression or death, whichever occurs first (up to approximately 40 months)
Secondary outcome [2] 0 0
Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1
Timepoint [2] 0 0
Baseline until disease progression or death, whichever occurs first (up to approximately 40 months)
Secondary outcome [3] 0 0
Percentage of Participants Who are Alive at Years 1 and 2
Timepoint [3] 0 0
Years 1 and 2
Secondary outcome [4] 0 0
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
Timepoint [4] 0 0
Baseline up to approximately 40 months
Secondary outcome [5] 0 0
TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
Timepoint [5] 0 0
Baseline up to approximately 40 months
Secondary outcome [6] 0 0
Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale
Timepoint [6] 0 0
Baseline up to approximately 40 months
Secondary outcome [7] 0 0
Percentage of Participants With Adverse Events
Timepoint [7] 0 0
Baseline up to approximately 40 months
Secondary outcome [8] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Timepoint [8] 0 0
Arms A and B: Baseline up to approximately 40 months
Secondary outcome [9] 0 0
Maximum Observed Serum Concentration (Cmax) of Atezolizumab - The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
Timepoint [9] 0 0
Arms A and B: Predose on Day (D) 1 of Cycle (Cy) 1,2,3,4,8,16 and every 8 cycles thereafter up to end of treatment (EOT) (approximately 40 months), 0.5 hours (h) post-infusion on D1 of Cy1,3, at 120 days after EOT (up to approximately 40 months)
Secondary outcome [10] 0 0
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion
Timepoint [10] 0 0
Arms A and B: Predose on D1 of Cy 1, 2, 3, 4, 8, 16 and every 8 cycles thereafter up to end of treatment (EOT) (approximately 40 months), at 120 days after EOT (up to approximately 40 months)
Secondary outcome [11] 0 0
Plasma Concentrations for Carboplatin
Timepoint [11] 0 0
Arm A, B and C: Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 h after carboplatin infusion (infusion duration=15 to 30 minutes) on D1 of Cy1,3 (1Cy=21 days)
Secondary outcome [12] 0 0
Plasma Concentrations for Paclitaxel
Timepoint [12] 0 0
Arm A, B and C: Predose (same day of treatment administration), 5-10 minutes before end of paclitaxel infusion, 1 h after paclitaxel infusion (infusion duration=3 h) on D1 of Cy1,3 (1Cy=21 days)
Secondary outcome [13] 0 0
Cmax of Bevacizumab
Timepoint [13] 0 0
Arms A and B: Predose on Day (D) 1 of Cycle (Cy) 1,2,3,4,8,16 and every 8 cycles thereafter up to end of treatment (EOT) (approximately 40 months), 0.5 hours (h) post-infusion on D1 of Cy1,3, at 120 days after EOT (up to approximately 40 months)
Secondary outcome [14] 0 0
Cmin of Bevacizumab
Timepoint [14] 0 0
Arm B and C: Predose (same day of treatment administration) on D1 of Cy1,3 (1 Cy=21 days), at bevacizumab discontinuation (up to approximately 44 months)

Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group performance status 0 or 1

- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC

- Participants with no prior treatment for Stage IV non-squamous NSCLC

- Known PD-L1 status as determined by immunohistochemistry assay performed on previously
obtained archival tumor tissue or tissue obtained from a biopsy at screening

- Measurable disease as defined by RECIST v1.1

- Adequate hematologic and end organ function
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cancer-Specific Exclusions:

- Active or untreated central nervous system metastases

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

General Medical Exclusions:

- Pregnant or lactating women

- History of autoimmune disease

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest computed tomography scan. History of radiation pneumonitis in the radiation
field (fibrosis) is permitted

- Positive test for human immunodeficiency virus

- Active hepatitis B or hepatitis C

- Severe infection within 4 weeks prior to randomization

- Significant cardiovascular disease

- Illness or condition that interferes with the participant's capacity to understand,
follow and/or comply with study procedures

Exclusion Criteria Related to Medications:

- Prior treatment with cluster of differentiation 137 agonists or immune checkpoint
blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies

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
Parallel
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Nepean Cancer Care Centre - Sydney
Recruitment hospital [4] 0 0
Prince Charles Hospital; Department of Medical Oncology - Chermside
Recruitment hospital [5] 0 0
Townsville Hospital - Townsville
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [9] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [10] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [11] 0 0
Frankston Hospital - Frankston
Recruitment hospital [12] 0 0
Austin Health - Heidelberg
Recruitment hospital [13] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [14] 0 0
The Alfred Hospital - Prahan
Recruitment hospital [15] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [16] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2747 - Sydney
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
4810 - Townsville
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
7250 - Launceston
Recruitment postcode(s) [11] 0 0
3199 - Frankston
Recruitment postcode(s) [12] 0 0
3084 - Heidelberg
Recruitment postcode(s) [13] 0 0
3144 - Malvern
Recruitment postcode(s) [14] 0 0
3181 - Prahan
Recruitment postcode(s) [15] 0 0
3021 - St Albans
Recruitment postcode(s) [16] 0 0
6009 - Nedlands
Recruitment outside Australia
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Lugo
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Madrid
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Bruderholz
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Changhua
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Liuying Township
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Putzu
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Taichung
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Tainan
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Taipei City
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Taipei
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Taiwan
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Taoyuan City
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Ukraine
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Chernihiv Governorate
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Ukraine
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Katerynoslav Governorate
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Ukraine
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Kharkiv Governorate
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Ukraine
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Kherson Governorate
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Ukraine
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KIEV Governorate
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Ukraine
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Kharkiv
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Ukraine
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Kryvyi Rih
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Ukraine
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Kyiv
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Ukraine
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Poltava
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Sumy
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Ukraine
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Uzhhorod

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

Ethics approval
Ethics application status

Summary
Brief summary
This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (an
engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with
carboplatin+paclitaxel with or without bevacizumab compared with treatment with
carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV
non-squamous NSCLC. Participants will be randomized in a 1:1:1 ratio to Arm A
(Atezolizumab+Carboplatin+Paclitaxel), Arm B
(Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C
(Carboplatin+Paclitaxel+Bevacizumab).
Trial website
https://clinicaltrials.gov/show/NCT02366143
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
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Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications