Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 combinat...
Eligibility Criteria
Inclusion
- 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:
- NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma
- Mixed NSCLC and small cell lung cancer histology
- 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
Exclusion
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT03456063
Start Date
April 24 2018
End Date
December 31 2025
Last Update
October 28 2025
Active Locations (119)
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1
Arizona Oncology
Tucson, Arizona, United States, 85711
2
USC Norris Cancer Center
Los Angeles, California, United States, 90033
3
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
Orange, California, United States, 92868
4
UC Davis Cancer Center
Sacramento, California, United States, 95817