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  • NCT04025879

Active, Not Recruiting

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer - CA209-77T

Oppdatert: 5 april, 2024   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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  • Phase 3

    Fase

  • Kjønn

  • 18+

    Aldersgruppe

  • Active, Not Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
Drug: Paclitaxel, Carboplatin, Cisplatin, Pemetrexed, Docetaxel Biological: Nivolumab
Placebo Comparator: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
Drug: Carboplatin, Cisplatin, Paclitaxel, Pemetrexed, Placebo, Docetaxel

Nøkkelkriterier for kvalifikasjon

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participants with suspected or histologically confirmed Stage IIA to IIIB non-small cell lung carcinoma (NSCLC) with disease that is considered resectable - No brain metastasis - Treatment-naive (no prior systemic anti-cancer treatment) - Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 - Ability to provide surgical or biopsy tumor tissue for biomarkers Exclusion Criteria: - Participants 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 - Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy Other protocol defined inclusion/exclusion criteria could apply

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Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046