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

• Conditions: Squamous Non-Small Cell Lung Cancer; Non-squamous Non-Small Cell Lung Cancer

• Registration Number: NCT02475382
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-16
• Study First Posted: 2015-06-18
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-25
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (2)

Local Institution; 🇨🇦 Montreal, Quebec, Canada

Centre De Sante Et De Services Sociaux Rimouski Neigette; 🇨🇦 Rimouski, Quebec, Canada