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Søg Study Connect

Not Yet Recruiting

An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease - CA209-9TN

Opdateret: 23 september, 2019   |   ClinicalTrials.gov

Udskriftsvenligt sammendrag

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Forsøgsdetaljer

  • Phase 2

    Fase

  • Køn

  • 18+

    Aldersinterval

  • 10

    Beliggenhed(er)

  • Not Yet Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
Experimental: Arm A
Other: Observation Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed Drug: Docetaxel Drug: Gemcitabine Drug: Vinorelbine Biological: Nivolumab
Active Comparator: Arm B
Other: Observation Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed Drug: Docetaxel Drug: Gemcitabine Drug: Vinorelbine

Primære egnethedskriterier

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria prior to Surgery: - Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is considered resectable - Must be deemed eligible for complete resection and must agree to undergo standard of care surgery for complete resection of NSCLC - Treatment naive (no previous systemic treatment) Inclusion Criteria prior to Treatment Randomization: - Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC - Must have adequately recovered from surgery at the time of randomization - Minimal residual disease (MRD) positive results as detected by ctDNA Exclusion Criteria prior to Surgery: - Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy (Prior to treatment randomization in select sites) - Active, known or suspected autoimmune disease - Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization Exclusion Criteria prior to Treatment Randomization: - Must continue to meet Exclusion Criteria prior to Surgery - Must have no evidence of metastatic disease after surgery - Received a live/attenuated vaccine within 30 days of first treatment 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

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