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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02366143
Ethics application status
Date submitted
12/02/2015
Date registered
19/02/2015
Date last updated
23/09/2021

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 received 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 received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.

Experimental: Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) - Participants received 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 received 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 received 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 received 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 was 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 was 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 was 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 was 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 in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population
Timepoint [1] 0 0
Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)
Primary outcome [2] 0 0
Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population
Timepoint [2] 0 0
Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)
Primary outcome [3] 0 0
Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population
Timepoint [3] 0 0
Baseline until death (up approximately 53 months)
Secondary outcome [1] 0 0
PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population
Timepoint [1] 0 0
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
Secondary outcome [2] 0 0
PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population
Timepoint [2] 0 0
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
Secondary outcome [3] 0 0
PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
Timepoint [3] 0 0
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
Secondary outcome [4] 0 0
PFS, as Determined by the Investigator in Arm B Versus Arm C by PD-L1 Subgroup
Timepoint [4] 0 0
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
Secondary outcome [5] 0 0
OS in Arm B Versus Arm C by PD-L1 Subgroup
Timepoint [5] 0 0
Baseline until death (up to approximately 34 months)
Secondary outcome [6] 0 0
OS in Arm A Versus Arm C by PD-L1 Subgroup
Timepoint [6] 0 0
Baseline until death (up approximately 53 months)
Secondary outcome [7] 0 0
OS in Arm B Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
Timepoint [7] 0 0
Baseline until death (up to approximately 34 months)
Secondary outcome [8] 0 0
OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
Timepoint [8] 0 0
Baseline until death (up approximately 53 months)
Secondary outcome [9] 0 0
OS in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
Timepoint [9] 0 0
Baseline until death (up approximately 53 months)
Secondary outcome [10] 0 0
Duration of Response (DOR), as Determined By Investigator in Arm B Versus Arm C
Timepoint [10] 0 0
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
Secondary outcome [11] 0 0
Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator in the Teff-High-WT Population and ITT-WT Population
Timepoint [11] 0 0
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
Secondary outcome [12] 0 0
OS Rates at Years 1 and 2 in Arm B Versus Arm C
Timepoint [12] 0 0
Baseline to 2 years or death, whichever occurs first.
Secondary outcome [13] 0 0
OS Rates at Years 1 and 2 in Arm A Versus Arm C
Timepoint [13] 0 0
Baseline to 2 years or death, whichever occurs first.
Secondary outcome [14] 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 [14] 0 0
Baseline up to approximately 29 months
Secondary outcome [15] 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 [15] 0 0
Baseline up to approximately 29 months
Secondary outcome [16] 0 0
Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale
Timepoint [16] 0 0
Baseline up to approximately 29 months
Secondary outcome [17] 0 0
Percentage of Participants With Adverse Events
Timepoint [17] 0 0
Baseline up to data cutoff date 7 December 2020 (up to approximately 68 months)
Secondary outcome [18] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Timepoint [18] 0 0
Baseline up to approximately 29 months
Secondary outcome [19] 0 0
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Arm A and Arm B
Timepoint [19] 0 0
Day 1 of Cycle 1 and 3 (Cycle length=21 days)
Secondary outcome [20] 0 0
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B
Timepoint [20] 0 0
Day 21 of Cycles 1, 2 3, and 7 (Cycle length=21 days)
Secondary outcome [21] 0 0
Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C
Timepoint [21] 0 0
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 (Cycle length=21 days)
Secondary outcome [22] 0 0
Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
Timepoint [22] 0 0
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 (Cycle length=21 days)
Secondary outcome [23] 0 0
Cmax of Bevacizumab in Arm B and Arm C
Timepoint [23] 0 0
Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length=21 days)
Secondary outcome [24] 0 0
Cmin of Bevacizumab in Arm B and Arm C
Timepoint [24] 0 0
Cycle 1 Day 1 and Cycle 2 Day 21 (Cycle length=21 days)

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/12/2020
Sample size
Target
Accrual to date
Final
1202
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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Ehime
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Kyoto
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Miyagi
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Niigata
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Osaka
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Tokyo
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Wakayama
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Riga
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Vilnius
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Breda
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EDE
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Hoofddorp
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Utrecht
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Zutphen
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Peru
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Lima
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Porto
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Moscow
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LAS Palmas
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Orense
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Spain
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Valencia
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Cordoba
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Spain
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Lugo
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Spain
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Madrid
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Switzerland
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Bruderholz
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Switzerland
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Luzern
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Switzerland
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St. Gallen
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Taiwan
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Changhua
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Taiwan
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Kaohsiung City
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Taiwan
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Liuying Township
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Taiwan
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Putzu
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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Taiwan
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Xitun Dist.
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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
Country [145] 0 0
Ukraine
State/province [145] 0 0
Kharkiv
Country [146] 0 0
Ukraine
State/province [146] 0 0
Kryvyi Rih
Country [147] 0 0
Ukraine
State/province [147] 0 0
Kyiv
Country [148] 0 0
Ukraine
State/province [148] 0 0
Poltava
Country [149] 0 0
Ukraine
State/province [149] 0 0
Sumy

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 evaluated 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 were 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/study/NCT02366143
Trial related presentations / publications
Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.
Nogami N, Barlesi F, Socinski MA, Reck M, Thomas CA, Cappuzzo F, Mok TSK, Finley G, Aerts JG, Orlandi F, Moro-Sibilot D, Jotte RM, Stroyakovskiy D, Villaruz LC, Rodriguez-Abreu D, Wan-Teck Lim D, Merritt D, Coleman S, Lee A, Shankar G, Yu W, Bara I, Nishio M. IMpower150 Final Exploratory Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in Key NSCLC Patient Subgroups With EGFR Mutations or Metastases in the Liver or Brain. J Thorac Oncol. 2022 Feb;17(2):309-323. doi: 10.1016/j.jtho.2021.09.014. Epub 2021 Oct 7.
Socinski MA, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kong S, Lee A, Coleman S, Zou W, McCleland M, Shankar G, Reck M. IMpower150 Final Overall Survival Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Nonsquamous NSCLC. J Thorac Oncol. 2021 Nov;16(11):1909-1924. doi: 10.1016/j.jtho.2021.07.009. Epub 2021 Jul 24.
Reck M, Wehler T, Orlandi F, Nogami N, Barone C, Moro-Sibilot D, Shtivelband M, Gonzalez Larriba JL, Rothenstein J, Fruh M, Yu W, Deng Y, Coleman S, Shankar G, Patel H, Kelsch C, Lee A, Piault E, Socinski MA. Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer. J Clin Oncol. 2020 Aug 1;38(22):2530-2542. doi: 10.1200/JCO.19.03158. Epub 2020 May 27.
Reck M, Mok TSK, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Lee A, Coleman S, Deng Y, Kowanetz M, Shankar G, Lin W, Socinski MA; IMpower150 Study Group. Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial. Lancet Respir Med. 2019 May;7(5):387-401. doi: 10.1016/S2213-2600(19)30084-0. Epub 2019 Mar 25.
Socinski MA, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kelsch C, Lee A, Coleman S, Deng Y, Shen Y, Kowanetz M, Lopez-Chavez A, Sandler A, Reck M; IMpower150 Study Group. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med. 2018 Jun 14;378(24):2288-2301. doi: 10.1056/NEJMoa1716948. Epub 2018 Jun 4.
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
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Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02366143