A Clinical Trial to Compare Atezolizumab plus Chemotherapy versus Chemotherapy Alone Before Surgery in Patients with Non-Small Cell Lung Cancer (IMpower030)
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)
- Cancer
- Lung Cancer
- Non-Small Cell Lung Cancer (NSCLC)
Active, not recruiting
- _
- Allentown
- Angers
- Ann Arbor
- Aurora
- Austin
- Baltimore
- Barcelona
- Be'er Sheva
- Beograd
- Bilbo
- Birmingham
- Box Hill
- Brighton
- Budapest
- Bunkyo City
- Busan
- Chang Wat Chiang Mai
- Charlotte
- Denver
- Detroit
- Dnipro
- Fairfax
- Freiburg im Breisgau
- Fukuoka
- Fukushima
- Gauting
- Gdańsk
- Gerlingen
- Golnik
- Großhansdorf
- Haifa
- Halle (Saale)
- Hiroshima
- Johannesburg
- Kaohsiung City
- Kefar Sava
- Kobe
- Kogarah
- Koto City
- Kraków
- Krung Thep Maha Nakhon
- Kurashiki
- Lausanne
- Leeds
- Linköping
- Linz
- Lombardia
- London
- Los Angeles
- Lund
- Lyon
- Madrid
- Melbourne
- Milano
- Minas Gerais
- Mineola
- Minneapolis
- Moscow
- Moscow Oblast
- Málaga
- Nagoya
- Nashville
- New Hyde Park
- New York
- Newport Beach
- Nishinomiya
- Okayama
- Oldenburg
- Omaha
- Orange
- Osaka
- Padova
- Palma
- Pamplona
- Peoria
- Pisa
- Pretoria
- Regensburg
- Rio Grande do Sul
- Rochester
- Roma
- Sabadell
- Sacramento
- Saint Petersburg
- Saint-Mandé
- Saint-Quentin
- San Diego
- Sendai
- Seoul
- Sevilla
- Shinjuku City
- Solna
- Springfield
- Strasbourg
- Suwon
- São Paulo
- Taichung City
- Taipei City
- Tel Aviv-Yafo
- Toulon
- Tucson
- Tyler
- Uppsala län
- València
- Vancouver
- Warszawa
- Washington
- Wien
- Wirral
- Würzburg
- xi-an-shi
- Zürich
- 横浜市
NCT03456063 GO40241
Trial 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 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.
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
Eligibility 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
- 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
For the latest version of this information please go to www.forpatients.roche.com