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Eine Studie zu Atezolizumab in Kombination mit Carboplatin + Paclitaxel oder Carboplatin + Nab-Paclitaxel im Vergleich zu Carboplatin + Nab-Paclitaxel bei Teilnehmenden mit plattenepithelialem nicht-kleinzelligem Lungenkrebs (NSCLC) im Stadium IV [IMpower131]
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]
- Krebs
- Lungenkrebs
- Nicht-kleinzelliges Lungenkarzinom
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Berlin
- Bielefeld
- Bochum
- Dresden
- Frankfurt am Main
- Großhansdorf
- Halle (Saale)
- Hamburg
- Hemer
- Homburg
- Immenhausen
- Köln
- Minden
- München
- Regensburg
- Rheine
- Stuttgart
- Villingen-Schwenningen
Studien-ID:
NCT02367794 2014-003208-59 GO29437
Studienzusammenfassung
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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02367794,GO29437,2014-003208-59
Studien-ID
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody, Carboplatin, Nab-Paclitaxel, Paclitaxel
Treatments
Squamous Non-Small Cell Lung Cancer
Condition
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
Einschlusskriterien
All
Gender
≥18 Years
Age
No
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
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