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A 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
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)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:
Active, not recruiting
This study runs in
Cities
- Aichi
- Allentown
- Angers
- Ann Arbor
- Austin
- Baltimore
- Bangkok
- Barcelona
- Beer Sheva
- Beograd
- Bilbao
- Birmingham
- Box Hill
- Brighton
- Budapest
- Busan
- Charlotte
- ChiangMai
- Denver
- Detroit
- Dnipropetrovsk
- Fairfax
- Freiburg
- Fukuoka
- Gauting
- gda-sk
- Golnik
- Großhansdorf
- Gyeonggi-do
- Haifa
- Halle
- Hiroshima
- Hyogo
- Johannesburg
- Kaohsiung
- Kfar Saba
- Kogarah
- Kraków
- Kyoto
- Lake Success
- Lausanne
- Linköping
- Linz
- London
- Los Angeles
- Lund
- Lyon
- Madrid
- Melbourne
- Milano
- Minas Gerais
- Mineola
- Minneapolis
- Miyagi
- Moscow
- Málaga
- Nashville
- New York
- Okayama
- Oldenburg
- Omaha
- Orange
- Osaka
- Padova
- Palma De Mallorca
- Pamplona
- Peoria
- Pisa
- Porto Alegre
- Pretoria
- Regensburg
- Rochester
- Roma
- Sabadell
- Sacramento
- Saint-Mandé
- Saint-Petersburg
- Saint-Quentin
- San Diego
- Seoul
- Sevilla
- Shanghai
- Solna
- Springfield
- St. Petersburg
- Strasbourg
- Stuttgart
- São Paulo
- Taipei City
- Tel Aviv
- Tokyo
- Toulon
- Tucson
- Tyler
- Uppsala län
- València
- Vancouver
- Warszawa
- Washington
- Wien
- Wirral
- Würzburg
- xitun-dist-
- Zürich
Study Identifier:
NCT03456063 2023-504209-35-00 GO40241
Study 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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT03456063, GO40241, 2023-504209-35-00
Study Identifier
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Placebo Comparator, Nab-paclitaxel, Pemetrexed, Carboplatin, Cisplatin
Treatments
Non-Small-Cell Lung
Condition
Official Title
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
All
Gender
≥ 18 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com