A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]

Cancer
Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 3

Study Identifier NCT02367794, GO29437, 2014-003208-59

Condition Squamous Non-Small Cell Lung Cancer

Official Title A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

Study Summary

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
Measurable disease as defined by RECIST v1.1
Adequate hematologic and end organ function

Exclusion Criteria

Active or untreated central nervous system (CNS) metastasis
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
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 (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Positive test for Human Immunodeficiency Virus (HIV)
Active hepatitis B or hepatitis C
Prior treatment with cluster of differentiation 137 (CD137) agonists 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

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

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

LPS_GO29437_IMpower131_final results_July2020_Arabic (PDF, 0.5 MB)

LPS_GO29437_IMpower131_final results_July2020_Bulgarian (PDF, 0.5 MB)

LPS_GO29437_IMpower131_final results_July2020_Chinese_Singapore (PDF, 0.5 MB)

LPS_GO29437_IMpower131_final results_July2020_Chinese_Traditional (PDF, 0.7 MB)

LPS_GO29437_IMpower131_final results_July2020_Dutch_Netherlands (PDF, 0.4 MB)

LPS_GO29437_IMpower131_final results_July2020_English (PDF, 0.7 MB)

LPS_GO29437_IMpower131_final results_July2020_French_France (PDF, 0.4 MB)

LPS_GO29437_IMpower131_final results_July2020_German (PDF, 0.4 MB)

LPS_GO29437_IMpower131_final results_July2020_Hebrew (PDF, 0.5 MB)

LPS_GO29437_IMpower131_final results_July2020_Italian (PDF, 0.4 MB)

LPS_GO29437_IMpower131_final results_July2020_Latvian (PDF, 0.5 MB)

LPS_GO29437_IMpower131_final results_July2020_Lithuainian (PDF, 0.5 MB)

LPS_GO29437_IMpower131_final results_July2020_Malay (PDF, 0.4 MB)

LPS_GO29437_IMpower131_final results_July2020_Portuguese (PDF, 0.4 MB)

LPS_GO29437_IMpower131_final results_July2020_Russian (PDF, 0.5 MB)

LPS_GO29437_IMpower131_final results_July2020_Slovak (PDF, 0.5 MB)

LPS_GO29437_IMpower131_final results_July2020_Spanish_Spain (PDF, 0.4 MB)

LPS_GO29437_IMpower131_final results_July2020_Ukrainian (PDF, 0.5 MB)

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]

For the latest version of this information please go to www.forpatients.roche.com