Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen (CheckMate 169)

Bristol-Myers Squibb (BMS)

Status

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

Treatments: Drug: Nivolumab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02475382

CA209-169

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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