Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or No… (NCT02475382) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen
Brazil
Plain-language summary
The purpose of this study is to provide treatment with nivolumab, a fully human monoclonal antibody, to subjects who have relapsed after treatment with a minimum of 1 prior systemic treatment for advanced or metastatic squamous (Sq) or non-squamous (non-Sq) non-small cell lung cancer (NSCLC) , Stage IIIB/IV and whose physicians believe that nivolumab treatment is appropriate.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Sq or Non-Sq NSCLC, Stage IIIb/IV (histologically or cytologically confirmed)
* Relapsed after 1 prior platinum-based systemic treatment
* Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2
* CNS metastasis must be treated and returned to baseline at least 2 weeks before first dose of nivolumab and off steroids or using stable or decreasing dose of \< 10 mg prednisone or equivalent
* Prior chemotherapy, Tyrosine Kinase Inhibitor (TKI) therapy or Immunotherapy (tumor vaccine, cytokine or growth factor to control cancer) must be completed at least 2 weeks before first nivolumab dose
Exclusion Criteria:
* CNS metastases (untreated and/or symptomatic)
* Carcinomatous meningitis
* ECOG Performance status \> 3
* Corticosteroids \> 10 mg prednisolone/day (or equivalent)
* Prior treatment with anti-PD-1, anti-PD-L-1, anti-PDL2, anti-CT137 or anti-CTLA antibody, including ipilimumab or any other drugs specifically targeting T cell costimulation or checkpoint pathways