A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:April 24, 2018
End Date:March 30, 2025
Contact:Reference Study ID Number: GO40241 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. Only)

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A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment With Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non−Small Cell Lung Cancer

This is a randomized, double-blinded study designed to evaluate the efficacy, safety,
pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A)
or placebo in combination with platinum-based chemotherapy in patients with resectable Stage
II, IIIA, or select IIIB non−small cell lung cancer (NSCLC) followed by open-label adjuvant
atezolizumab or best supportive care and monitoring.


Inclusion criteria:

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

- Histologically or cytologically confirmed, resectable Stage II, IIIA, or Select IIIB
(T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on
the 8th edition of the AJCC/UICC staging system

- Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection
with curative intent

- Adequate pulmonary and cardiac function to undergo surgical resection

- Measurable disease as defined by RECIST v1.1

- Adequate hematologic and end organ function

- Negative HIV test at screening

- Negative for active HBV and HCV at screening

- Adequate tissue for PD-L1 IHC assessment

Exclusion criteria:

- Any prior therapy for lung cancer

- Malignancies other than NSCLC within 5 years prior to randomization, with the
exception of those with a negligible risk of metastasis or death treated expected
curative outcome

- Non-squamous NSCLC histology with activating ALK and EGFR mutation

- Pregnant or lactating women

- History of autoimmune disease

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or evidence of active of active pneumonitis on screening chest Computed
Tomography (CT) scan

- Prior treatment with cluster of differentiation 137 (CD137) agonist 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
We found this trial at
31
sites
8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Allentown, Pennsylvania 18105
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Austin, Texas 78745
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Baltimore, Maryland 21201
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Charlotte, North Carolina 28211
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Cincinnati, Ohio 45242
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Denver, Colorado 80218
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Fullerton, California 92835
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100 Mercy Way
Joplin, Missouri 64804
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Kogarah, New South Wales 2217
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Lake Success, New York
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Los Angeles, California 90033
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910 East 26th Street
Minneapolis, Minnesota 55404
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Nashville, Tennessee 37203
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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520 Superior Avenue
Newport Beach, California 92663
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Omaha, NE
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1010 West La Veta Avenue
Orange, California 92868
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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4501 X Street
Sacramento, California 95817
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San Diego, California 92037
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Springfield, Missouri 65804
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Truckee, CA
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Tucson, Arizona 85710
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721 Clinic Drive
Tyler, Texas 75701
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Vancouver, Washington 98684
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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Washington, District of Columbia 20010
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