A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)



Status:Terminated
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:May 7, 2015
End Date:December 7, 2017

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

A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Gemcitabine+Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

This randomized, open-label study was designed to evaluate and compare the safety and
efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected
participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to
low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC
into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no
longer applicable and formal analyses of efficacy or safety have not been performed.


Inclusion Criteria:

- Histologically or cytologically confirmed Stage IV squamous NSCLC

- Tumor programmed death-ligand 1 (PD-L1) expression, as determined by
immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at
screening

- No prior treatment for Stage IV squamous NSCLC

- Measurable disease as defined by RECIST v1.1

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate hematologic and end-organ function

Exclusion Criteria:

- Active or untreated central nervous system (CNS) metastases

- Untreated or inadequately treated spinal cord compression

- Leptomeningeal disease

- Uncontrolled pleural effusion, pericardial effusion, or ascites

- Uncontrolled tumor-related pain

- Uncontrolled hypercalcemia

- Any other malignancies within 5 years except those with negligible risk of metastasis
or death

- Pregnant or lactating women

- Known hypersensitivity to any component of atezolizumab formulation or other study
medication

- History of autoimmune disease except controlled, treated hypothyroidism or type I
diabetes

- Prior allogeneic bone marrow or solid organ transplantation

- Positive human immunodeficiency virus (HIV) test

- Active hepatitis B or C

- Active tuberculosis

- Significant cardiovascular disease

- Severe infection or major surgery within 4 weeks prior to randomization

- Use of any approved anti-cancer therapy within 3 weeks prior to treatment

- Use of an investigational agent or participation in another clinical trial within 4
weeks prior to randomization

- Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4
weeks prior to randomization

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

- Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents
within 2 weeks prior to randomization
We found this trial at
29
sites
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
Auburn, Washington 98002
?
mi
from
Auburn, WA
Click here to add this to my saved trials
Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
1 Medical Park Boulevard
Bristol, Tennessee 37620
?
mi
from
Bristol, TN
Click here to add this to my saved trials
4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
?
mi
from
Brooklyn, NY
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
979 E 3rd St # A540
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Easton, Maryland 21601
?
mi
from
Easton, MD
Click here to add this to my saved trials
?
mi
from
Encinitas, CA
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
Greenbrae, California 94904
?
mi
from
Greenbrae, CA
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
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
?
mi
from
Hershey, PA
Click here to add this to my saved trials
2406 Century Place Southeast
Hickory, North Carolina 28602
?
mi
from
Hickory, NC
Click here to add this to my saved trials
888 South King Street
Honolulu, Hawaii 96813
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
?
mi
from
La Jolla, CA
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
Miami Beach, Florida 33140
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
Missoula, Montana 59802
?
mi
from
Missoula, MT
Click here to add this to my saved trials
Morgantown, West Virginia
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
Nashville, Tennessee 37212
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Norwich, CT
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
44 Kyjevská
Pardubice, 53203
?
mi
from
Pardubice,
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
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
Summit, New Jersey 07902
?
mi
from
Summit, NJ
Click here to add this to my saved trials
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
?
mi
from
Washington,
Click here to add this to my saved trials