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  • NCT02477826
This clinical trial is no longer recruiting patients.

Active, Not Recruiting

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) - CA209-227

Opdateret: 5 januar, 2024   |   ClinicalTrials.gov

Udskriftsvenligt sammendrag

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Udskriv denne side CA209-227
Hente vejledningen til forsøgsdeltagere

VÆLG SPROG

Forsøgsdetaljer

  • Phase 3

    Fase

  • Køn

  • 18+

    Aldersinterval

  • Active, Not Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
Experimental: Arm A: Nivolumab
Drug: Nivolumab
Experimental: Arm B: Nivolumab + Ipilimumab
Drug: Nivolumab, Ipilimumab
Experimental: Arm C: Nivolumab + Platinum doublet chemotherapy
Drug: Nivolumab, Carboplatin, Cisplatin, Gemcitabine, Pemetrexed, Paclitaxel
Experimental: Arm D: Platinum doublet chemotherapy
Drug: Carboplatin, Cisplatin, Gemcitabine, Pemetrexed, Paclitaxel

Primære egnethedskriterier

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy - Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period - Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 - Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria Exclusion Criteria: - Subjects with untreated Central nervous system (CNS) metastases are excluded - Subjects with an active, known or suspected autoimmune disease are excluded - Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection Other protocol defined inclusion/exclusion criteria could apply

Hvis du vil rapportere en bivirkning, kan du indberette direkte til Lægemiddelstyrelsen via hjemmesiden www.meldenbivirkning.dk
Vi anbefaler at du også kontakter BMS for at rapportere bivirkninger.
Bivirkninger og andre rapporterbare begivenheder er defineret her
Rapporter bivirkninger eller klager over produktkvalitet: Medicinsk information

466-DK-2200001