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) |
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.
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
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
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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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
Newport Beach, California 92663
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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1010 West La Veta Avenue
Orange, California 92868
Orange, California 92868
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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