A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

Cancer
Lung Cancer
Non Small Cell Lung Carcinoma
Non-squamous non-small cell lung cancer
Non-Small Cell Lung Cancer (NSCLC)

For Medical Professional
Results
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 3

Study Identifier NCT02409342, GO29431, 2014-003083-21

Condition Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer

Official Title A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer

Study Summary

This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.

Eligibility Criteria

Gender

All

Age

≥ 18 Years

Healthy Volunteers

Inclusion Criteria

Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study
Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Adequate hematologic and end-organ function

Exclusion Criteria

Known sensitizing mutation in the EGFR gene or ALK fusion oncogene
Active or untreated central nervous system (CNS) metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation
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 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 (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody
Severe infection within 4 weeks prior to randomization
Significant history of cardiovascular disease

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

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 (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

Study results

LPS GO29431 IMpower110 Interim Results November 2020 English (PDF, 0.3 MB)

LPS GO29431 IMpower110 Interim Results November 2020 German (PDF, 0.4 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Chinese (PDF, 0.3 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Ukrainian (PDF, 0.2 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Thai (PDF, 0.7 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Turkish (PDF, 0.2 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Spanish (PDF, 0.3 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Romanian (PDF, 0.4 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Russian (PDF, 0.2 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Serbian (PDF, 0.2 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Polish (PDF, 0.4 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Portuguese (PDF, 0.2 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Italian (PDF, 0.3 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Korean (PDF, 0.2 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Greek (PDF, 0.3 MB)

LPS GO29431 IMpower110 Interim Results November 2020 Hungarian (PDF, 0.3 MB)

LPS GO29431 IMpower110 Interim Results November 2020 French (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 (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

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