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A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Cancer Lung Cancer Non-Small Cell Lung Cancer (NSCLC)
Basic Details
Study Summary
This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).
Eligibility Criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
- Participants with no prior treatment for Stage IV non-squamous NSCLC
- Previously obtained archival tumor tissue or tissue obtained from fresh biopsy at screening
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function
Cancer-Specific Exclusions:
- Active or untreated central nervous system metastases
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
General Medical Exclusions:
- Pregnant or lactating women
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Positive test for human immunodeficiency virus
- Active hepatitis B or hepatitis C
- Severe infection within 4 weeks prior to randomization
- Significant cardiovascular disease
- Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures
Exclusion Criteria Related to Medications:
- Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
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Study results
LPS GO29537 IMpower130 Final Results February 2021 Arabic
(PDF, 1.0 MB)
LPS GO29537 IMpower130 Final Results February 2021 Dutch Belgium
(PDF, 1.0 MB)
LPS GO29537 IMpower130 Final Results February 2021 English
(PDF, 0.9 MB)
LPS GO29537 IMpower130 Final Results February 2021 French France
(PDF, 1.0 MB)
LPS GO29537 IMpower130 Final Results February 2021 German
(PDF, 0.9 MB)
LPS GO29537 IMpower130 Final Results February 2021 Hebrew
(PDF, 1.0 MB)
LPS GO29537 IMpower130 Final Results February 2021 Italian
(PDF, 0.9 MB)
LPS GO29537 IMpower130 Final Results February 2021 Russian
(PDF, 1.0 MB)
LPS GO29537 IMpower130 Final Results February 2021 Spanish Spain
(PDF, 0.9 MB)
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For the latest version of this information please go to www.forpatients.roche.com