Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:October 31, 2015
End Date:December 17, 2027

Use our guide to learn which trials are right for you!

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

This is a Phase III, global, multicenter, open-label, randomized study to compare the
efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A)
treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA
non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured
by disease-free survival (DFS) as assessed by the investigator and overall survival (OS).
Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will
be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.


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 [ 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

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
We found this trial at
103
sites
Morristown, New Jersey 07962
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
?
mi
from
Port Saint Lucie, FL
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
?
mi
from
Providence, RI
Click here to add this to my saved trials
Ann Arbor, Michigan 48106
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
3320 Old Jefferson Road
Athens, Georgia 30607
?
mi
from
Athens, GA
Click here to add this to my saved trials
Auburn, Washington 98002
?
mi
from
Auburn, WA
Click here to add this to my saved trials
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
9400 Rosecrans Avenue
Bellflower, California 90706
?
mi
from
Bellflower, CA
Click here to add this to my saved trials
Bend, Oregon 97701
?
mi
from
Bend, OR
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
701 Ostrum Street
Bethlehem, Pennsylvania 18015
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
701 Northwest 13th Street
Boca Raton, Florida 33428
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
1400 VFW Parkway
Boston, Massachusetts 02132
?
mi
from
Boston, MA
Click here to add this to my saved trials
410 Stagecoach Road
Bristol, Virginia 24201
?
mi
from
Bristol, VA
Click here to add this to my saved trials
Carrollton, Georgia 30117
?
mi
from
Carrollton, GA
Click here to add this to my saved trials
200 Hawthorne Ln
Charlotte, North Carolina 28204
(704) 384-4000
Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
979 E 3rd St # A540
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
4350 Malsbary Road
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbia, Maryland 21044
?
mi
from
Columbia, MD
Click here to add this to my saved trials
3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Corona, CA
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
1192 East Newport Center Drive
Deerfield Beach, Florida 33442
?
mi
from
Deerfield Beach, FL
Click here to add this to my saved trials
800 West Magnolia Avenue
Denton, Texas 76210
?
mi
from
Denton, TX
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
?
mi
from
Englewood, NJ
Click here to add this to my saved trials
Everett, Washington 98201
?
mi
from
Everett, WA
Click here to add this to my saved trials
?
mi
from
Florham Park, NJ
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Frederick, Maryland 21701
?
mi
from
Frederick, MD
Click here to add this to my saved trials
?
mi
from
Fredericksburg, VA
Click here to add this to my saved trials
6409 North Quail Hollow Road
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Greenbrae, California 94904
?
mi
from
Greenbrae, CA
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Harrisburg, Pennsylvania 17043
?
mi
from
Harrisburg, PA
Click here to add this to my saved trials
1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
?
mi
from
Harvey, IL
Click here to add this to my saved trials
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Joliet, IL
Click here to add this to my saved trials
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Lake Success, New York 11042
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
Lincoln, Nebraska 68510
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
4301 West Markham Street
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
?
mi
from
Livingston, NJ
Click here to add this to my saved trials
Louisville, Kentucky 40207
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Louisville, Kentucky 40207
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
6111 East Arbor Avenue
Mesa, Arizona 85206
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Miami Beach, Florida 33140
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Norwich, CT
Click here to add this to my saved trials
Oakland, California 94611
?
mi
from
Oakland, CA
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
1 Valley Health Plaza
Paramus, New Jersey 07652
?
mi
from
Paramus, NJ
Click here to add this to my saved trials
Park Ridge, Illinois 60068
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
Peoria, Illinois 61656
?
mi
from
Peoria, IL
Click here to add this to my saved trials
Pinehurst, North Carolina 28374
?
mi
from
Pinehurst, NC
Click here to add this to my saved trials
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
1005 Broadway Street
Quincy, Illinois 62301
?
mi
from
Quincy, IL
Click here to add this to my saved trials
Richmond, Virginia 23235
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rogers, Arkansas 72758
?
mi
from
Rogers, AR
Click here to add this to my saved trials
Roseville, California 95661
?
mi
from
Roseville, CA
Click here to add this to my saved trials
2025 Morse Avenue
Sacramento, California 95825
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
1201 5th Avenue North
Saint Petersburg, Florida 33705
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salisbury, North Carolina 28144
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Jose, California 95119
?
mi
from
San Jose, CA
Click here to add this to my saved trials
2500 Merced Street
San Leandro, California 94577
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
Santa Clara, California 95051
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials
405 Hilgard Avenue
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Scarborough, Maine 04074
?
mi
from
Scarborough, ME
Click here to add this to my saved trials
9055 East Del Camino Drive
Scottsdale, Arizona 85258
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
1660 South Columbian Way
Seattle, Washington 98108
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sepulveda, California 91343
?
mi
from
Sepulveda, CA
Click here to add this to my saved trials
Sewell, New Jersey 08080
?
mi
from
Sewell, NJ
Click here to add this to my saved trials
230 Nebraska St.
Sioux City, Iowa 51101
712-252-0088
Siouxland Hematology-Oncology Associates, LLP Siouxland Hematology-Oncology Associates (SHOA) provides medical oncology treatment. In addition to...
?
mi
from
Sioux City, IA
Click here to add this to my saved trials
South San Francisco, California 94080
?
mi
from
South San Francisco, CA
Click here to add this to my saved trials
101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
?
mi
from
Springfield, IL
Click here to add this to my saved trials
99 Beauvoir Avenue
Summit, New Jersey 07901
?
mi
from
Summit, NJ
Click here to add this to my saved trials
Tallahassee, Florida 32308
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Thomasville, Georgia 31792
?
mi
from
Thomasville, GA
Click here to add this to my saved trials
100 Angus Smith Drive
Townsville, Queensland 4814
?
mi
from
Townsville,
Click here to add this to my saved trials
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
Vallejo, California 94589
?
mi
from
Vallejo, CA
Click here to add this to my saved trials