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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-Small-Cell Lung

In brief

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 participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.

Key facts

Study ID

NCT03456063

Run by

Hoffmann-La Roche

People needed

453

Starts

2018-04-24

Expected to finish

2025-12-31

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• USC Norris Cancer Center — Los Angeles, California, United States
• The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange — Orange, California, United States
• UC Davis Cancer Center — Sacramento, California, United States
• Scripps Clinic — San Diego, California, United States
• National Jewish Health — Denver, Colorado, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Washington Cancer Institute — Washington D.C., District of Columbia, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• Uni of Maryland Cancer Center — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Brighton Center for Specialty Care — Brighton, Michigan, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Minnesota Oncology Minneapolis — Minneapolis, Minnesota, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Mercy Clinic Cancer & Hematology — Springfield, Missouri, United States
• Nebraska Methodist Estabrook Cancer Center — Omaha, Nebraska, United States
• Northwell Health — Lake Success, New York, United States
• NYU Winthrop Hospital — Mineola, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Sarah Cannon Research Institute / Tennessee Oncology — Nashville, Tennessee, United States
• Arizona Oncology — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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