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Eine Studie zu Atezolizumab in Kombination mit Carboplatin plus Nab-Paclitaxel im Vergleich zu Carboplatin plus Nab-Paclitaxel bei Teilnehmenden mit nicht-plattenepithelialem, nicht-kleinzelligem Lungenkrebs (NSCLC) im Stadium IV
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) (IMpower130)
- 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
- Chemnitz
- Ebensfeld
- Erfurt
- Eschweiler
- Esslingen am Neckar
- Flensburg
- Frankfurt am Main
- Gera
- Hannover
- Heidelberg
- Immenhausen
- Karlsruhe
- Kassel
- Koblenz
- Lübeck
- Mannheim
- Minden
- München
- Stuttgart
- Tübingen
- Velbert
- Villingen-Schwenningen
- Wuppertal
Studien-ID:
NCT02367781 2014-003206-32 GO29537
Studienzusammenfassung
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).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02367781, GO29537, 2014-003206-32
Studien-ID
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin, Nab-Paclitaxel, Pemetrexed
Treatments
Carcinoma, Non-Squamous Non-Small Cell Lung
Condition
Official Title
A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Einschlusskriterien
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion 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
Exclusion Criteria
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
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