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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02367794




Registration number
NCT02367794
Ethics application status
Date submitted
13/02/2015
Date registered
20/02/2015
Date last updated
30/04/2020

Titles & IDs
Public title
A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]
Scientific title
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2014-003208-59
Secondary ID [2] 0 0
GO29437
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous 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 (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody
Treatment: Drugs - Carboplatin
Treatment: Drugs - Nab-Paclitaxel
Treatment: Drugs - Paclitaxel

Experimental: Arm A: Atezolizumab + Paclitaxel + Carboplatin - The induction phase of the study will consist of four or six cycles; atezolizumab, paclitaxel, and carboplatin will be administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.

Experimental: Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin - The induction phase of the study will consist of four or six cycles; atezolizumab and carboplatin will be administered on Day 1 of each 21-day cycle. Nab-Paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.

Active Comparator: Arm C: Nab-Paclitaxel + Carboplatin - The induction phase of the study will consist of four or six cycles; carboplatin will be administered on Day 1 of each 21-day cycle, nab-paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: nab-paclitaxel, then carboplatin. Participants who experience disease progression at any time during the induction phase will discontinue all study treatment. In the maintenance phase, participants will receive best supportive care.


Treatment: Drugs: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody
Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.

Treatment: Drugs: Carboplatin
Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.

Treatment: Drugs: Nab-Paclitaxel
Nab-paclitaxel 100 milligrams per meter squared (mg/m^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.

Treatment: Drugs: Paclitaxel
Paclitaxel 200 mg/m^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m^2 IV.

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 v1.1) in the Intent-to-Treat (ITT) Population - PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT population.
Timepoint [1] 0 0
Up to approximately 30 months after first participant enrolled
Primary outcome [2] 0 0
Overall Survival (OS) in the ITT Population - OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
Timepoint [2] 0 0
Up to approximately 39 months after first participant enrolled
Secondary outcome [1] 0 0
OS in the Tumor Gene Expression (tGE) Population
Timepoint [1] 0 0
Up to approximately 39 months after first participant enrolled
Secondary outcome [2] 0 0
PFS as Determined by the Investigator Using RECIST v1.1 in the tGE Population
Timepoint [2] 0 0
Up to approximately 30 months after first participant enrolled
Secondary outcome [3] 0 0
PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population
Timepoint [3] 0 0
Up to approximately 30 months after first participant enrolled
Secondary outcome [4] 0 0
PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population
Timepoint [4] 0 0
Up to approximately 30 months after first participant enrolled
Secondary outcome [5] 0 0
OS in the TC2/3 or IC2/3 Population
Timepoint [5] 0 0
Up to approximately 39 months after first participant enrolled
Secondary outcome [6] 0 0
OS in the TC1/2/3 or IC1/2/3 Population
Timepoint [6] 0 0
Up to approximately 39 months after first participant enrolled
Secondary outcome [7] 0 0
Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population
Timepoint [7] 0 0
Up to approximately 30 months after first participant enrolled
Secondary outcome [8] 0 0
Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population
Timepoint [8] 0 0
Up to approximately 30 months after first participant enrolled
Secondary outcome [9] 0 0
OS at 1 and 2 Years in the ITT Population - OS rates at 1 and 2 years is defined as the proportion of participants alive at 1 and 2 years after randomization estimated using Kaplan-Meier (KM) methodology for the ITT population
Timepoint [9] 0 0
1 and 2 years
Secondary outcome [10] 0 0
Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population
Timepoint [10] 0 0
Up to approximately 30 months after first participant enrolled
Secondary outcome [11] 0 0
TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population
Timepoint [11] 0 0
Up to approximately 30 months after the first participant enrolled
Secondary outcome [12] 0 0
Change From Baseline in Patient-reported Lung Cancer Symptoms Score Using the SILC Scale Symptom Severity Score in the ITT Population
Timepoint [12] 0 0
Baseline up to approximately 30 months after first participant enrolled
Secondary outcome [13] 0 0
PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A vs. Arm B)
Timepoint [13] 0 0
Up to approximately 30 months after first participant enrolled
Secondary outcome [14] 0 0
OS in the ITT Population (Arm A vs. Arm B)
Timepoint [14] 0 0
Up to approximately 39 months after first participant enrolled
Secondary outcome [15] 0 0
Percentage of Participants With Adverse Events
Timepoint [15] 0 0
Up to approximately 39 months after first participant enrolled
Secondary outcome [16] 0 0
Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab - The predose samples will be collected on the same day of treatment administration.
Timepoint [16] 0 0
Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 39 months), at treatment discontinuation (up to 39 months), and at 120 days after the last dose of atezolizumab (up to approximately 39 months, each cycle is 21 days)
Secondary outcome [17] 0 0
Maximum Observed Serum Atezolizumab Concentration (Cmax) - 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 [17] 0 0
Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle up to 39 months; 30 minutes postdose on Day 1 of Cycles 1 and 3; at treatment discontinuation (up to 39 months), and at 120 days after last dose of atezolizumab (up to 39 months, each cycle is 21 days)
Secondary outcome [18] 0 0
Minimum Observed Serum Atezolizumab Concentration (Cmin) - The predose samples will be collected on the same day of treatment administration.
Timepoint [18] 0 0
Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 39 months), at treatment discontinuation (up to 39 months), and at 120 days after the last dose of atezolizumab (up to approximately 39 months, each cycle is 21 days)
Secondary outcome [19] 0 0
Plasma Concentrations for Paclitaxel
Timepoint [19] 0 0
Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 180 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)
Secondary outcome [20] 0 0
Plasma Concentrations for Nab-Paclitaxel
Timepoint [20] 0 0
Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)
Secondary outcome [21] 0 0
Plasma Concentrations for Carboplatin
Timepoint [21] 0 0
Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 15 to 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)

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

- Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC

- Previously obtained archival tumor tissue or tissue obtained from 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
- Active or untreated central nervous system (CNS) metastasis

- 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

- 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 (CT) scan, History of radiation pneumonitis in the radiation
field (fibrosis) is permitted

- Positive test for Human Immunodeficiency Virus (HIV)

- Active hepatitis B or hepatitis C

- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1
therapeutic antibody

- Severe infection within 4 weeks prior to randomization

- Significant history of cardiovascular disease

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,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [3] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [4] 0 0
Townsville Hospital - Townsville
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment hospital [8] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [9] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [10] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4810 - Townsville
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment postcode(s) [9] 0 0
3021 - St Albans
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
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Campania
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LAS Palmas
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Lugo
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Madrid
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Valencia
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Zaragoza
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Changhua
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Kaohsiung City
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Liuying Township
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Putzu
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Taichung
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Taipei City
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Taipei
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Katerynoslav Governorate
Country [153] 0 0
Ukraine
State/province [153] 0 0
Kharkiv Governorate
Country [154] 0 0
Ukraine
State/province [154] 0 0
KIEV Governorate
Country [155] 0 0
Ukraine
State/province [155] 0 0
Volhynian Governorate
Country [156] 0 0
Ukraine
State/province [156] 0 0
Chernivtsi
Country [157] 0 0
Ukraine
State/province [157] 0 0
Kharkiv
Country [158] 0 0
Ukraine
State/province [158] 0 0
Kryvyi Rih
Country [159] 0 0
Ukraine
State/province [159] 0 0
Poltava
Country [160] 0 0
Ukraine
State/province [160] 0 0
Sumy
Country [161] 0 0
Ukraine
State/province [161] 0 0
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
(MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel
compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants
with Stage IV squamous NSCLC.
Trial website
https://clinicaltrials.gov/show/NCT02367794
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
Other publications