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Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT02475382
Acronym
CheckMate 169
Enrollment
Unknown
Registered
2015-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2020-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer

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.

Interventions

DRUGNivolumab

Specified dose on specified days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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

Countries

Brazil, Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026