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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02486718




Registration number
NCT02486718
Ethics application status
Date submitted
4/06/2015
Date registered
1/07/2015
Date last updated
20/08/2024

Titles & IDs
Public title
Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
Scientific title
A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2014-003205-15
Secondary ID [2] 0 0
GO29527
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 - Cisplatin
Treatment: Drugs - Vinorelbine
Treatment: Drugs - Docetaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Pemetrexed

Experimental: Atezolizumab - Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.

Active comparator: Best Supportive Care - Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.


Treatment: Drugs: Atezolizumab
Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).

Treatment: Drugs: Cisplatin
Participants will receive cisplatin 75 milligrams per square meter (mg/m\^2) IV on Day 1 of up to four 21-day cycles.

Treatment: Drugs: Vinorelbine
Participants will receive vinorelbine 30 mg/m\^2 IV on Days 1 and 8 of each of the four 21-day cycles.

Treatment: Drugs: Docetaxel
Participants will receive docetaxel 75 mg/m\^2 IV on Day 1 of each of the four 21-day cycles.

Treatment: Drugs: Gemcitabine
Participants will receive gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each of the four 21-day cycles.

Treatment: Drugs: Pemetrexed
Participants will receive pemetrexed 500 mg/m\^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-Free Survival (DFS), Assessed Using Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/X-Ray
Timepoint [1] 0 0
From randomization to the date of first recurrence of NSCLC, occurrence of new primary NSCLC, or death from any cause, whichever occurs first (up to approximately 131 months)
Secondary outcome [1] 0 0
Overall Survival (OS) in the ITT Population
Timepoint [1] 0 0
Baseline up to death from any cause (up to approximately 131 months)
Secondary outcome [2] 0 0
Percentage of Participants Who are Disease-Free at Year 3, Assessed Using CT/MRI/X-Ray
Timepoint [2] 0 0
Year 3
Secondary outcome [3] 0 0
Percentage of Participants Who are Disease-Free at Year 5, Assessed Using CT/MRI/X-Ray
Timepoint [3] 0 0
Year 5
Secondary outcome [4] 0 0
DFS Within Selected Populations
Timepoint [4] 0 0
From randomization to the date of first recurrence of NSCLC, occurrence of new primary NSCLC, or death from any cause, whichever occurs first (up to approximately 67 months)
Secondary outcome [5] 0 0
Percentage of Participants with Adverse Events
Timepoint [5] 0 0
Baseline up to approximately 131 months
Secondary outcome [6] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Timepoint [6] 0 0
Predose (Hour 0) on Day (D) 1 of Cycles (Cy) 1, 2, 3, 4, 8, 16 (Cy length=21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 months)
Secondary outcome [7] 0 0
Maximum Plasma Concentration (Cmax) of Atezolizumab
Timepoint [7] 0 0
Post-infusion on Day 1 of Cycle 1 (cy length = 21 days)
Secondary outcome [8] 0 0
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Timepoint [8] 0 0
Prior to infusion on D1 of Cy2, 3, 4, 8, 16 (Cy length = 21 days), and at study termination (up to approximately 131 months)

Eligibility
Key inclusion criteria
Inclusion Criteria for Enrollment Phase

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histological or cytological diagnosis of Stage IB (tumors greater than or equal to [>/=] 4 centimeters [cm])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009)
* Participants must have had complete resection of NSCLC 4-12 weeks (>/=28 days and less than or equal to [</=] 84 days) prior to enrollment and must be adequately recovered from surgery
* If mediastinoscopy was not performed preoperatively, it is required that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the participant will be considered eligible if no lymph nodes are found in those areas; if participants have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative staging imaging results (contrast computed tomography [CT] and positron emission tomography [PET] scans) do not suggest evidence of disease in the mediastinum, the participant will be considered eligible if N2 nodal sampling is not performed per surgeon's decision
* Eligible to receive a cisplatin-based chemotherapy regimen
* Adequate hematologic and end-organ function
* Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin-based chemotherapy

Inclusion Criteria for Randomized Phase - Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of atezolizumab or BSC
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for Enrollment Phase

* Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures
* Pregnant and lactating women
* Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor
* Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment
* Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment
* Participants with hearing impairment
* Known sensitivity to any component of the chemotherapy regimen the participant will be assigned to, or to mannitol
* Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti programmed death ligand 1 (PD-L1) therapeutic antibodies
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS greater than [>] 90 percent [%]) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
* Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
* History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
* Positive test for human immunodeficiency virus (HIV)
* Participants with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
* Active tuberculosis
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within the previous 3 months, unstable arrhythmias, or unstable angina
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
* Prior allogeneic bone marrow transplantation or solid organ transplant
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
* Known tumor PD-L1 expression status as determined by an immunohistochemistry (IHC) assay from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies but were not eligible are excluded)

Specific Exclusions for Pemetrexed Treatment

- Participants with squamous cell histology

Exclusion Criteria for Randomized Phase

* Signs or symptoms of infection within 14 days prior to randomization (severe infection within 28 days prior to randomization), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
* Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to randomization
* Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
* Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study
* Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization: Prior treatment with cancer vaccines is allowed
* Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization

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
31/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2035
Actual
Sample size
Target
Accrual to date
Final
1280
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Townsville Hospital - Townsville
Recruitment hospital [2] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment postcode(s) [1] 0 0
4810 - Townsville
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment outside Australia
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Arkansas
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California
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Connecticut
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Hemer
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Homburg
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Immenhausen
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Karlsruhe
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Koln
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Velbert
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Shatin
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Pecs
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Sicilia
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Umbria
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Suwon
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Netherlands
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'S Hertogenbosch
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Groningen
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Otwock
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Mordovija
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LA Coruña
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Murcia
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Cordoba
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Jaen
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Lugo
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Madrid
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Valencia
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Zaragoza
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Taiwan
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Chang Hua
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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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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.
Country [147] 0 0
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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KIEV Governorate
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Ukraine
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Poltava Governorate
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Ukraine
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Kirovograd
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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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Sumy
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Ukraine
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Zaporizhzhya
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United Kingdom
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Birmingham
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United Kingdom
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Colchester, Essex
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United Kingdom
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London

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

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Results publications and other study-related documents

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Results not provided in https://clinicaltrials.gov/study/NCT02486718