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Clinical Trials/NCT02475382
NCT02475382
No Longer Available
Not Applicable

Expanded Access Program With Nivolumab Monotherapy in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC

Bristol-Myers Squibb2 sites in 1 countryJune 18, 2015
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ConditionsSquamous Non-Small Cell Lung CancerNon-squamous Non-Small Cell Lung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Squamous Non-Small Cell Lung Cancer
Sponsor
Bristol-Myers Squibb
Locations
2
Status
No Longer Available
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 18, 2015
End Date
TBD
Last Updated
5 years ago
Study Type
Expanded Access
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Study Sites (2)

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