Clinical trial NCT02475382: Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen
Official title: 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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Squamous Non-Small Cell Lung Cancer
Non-squamous Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-06-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Fortaleza
country: Brazil
facility: Local Institution
state: Ceara
city: Fortaleza
country: Brazil
facility: Local Institution
state: Ceara
city: Brasilia
country: Brazil
facility: Local Institution
state: Distrito Federal
city: Belo Horizonte
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Cascavel
country: Brazil
facility: Local Institution
state: Parana
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Recife
country: Brazil
facility: Local Institution
state: Pernambuco
city: Recife
country: Brazil
facility: Local Institution
state: Pernambuco
city: Natal
country: Brazil
facility: Local Institution
state: Rio Grande Do Norte
city: Ijui
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Passo Fundo
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Florianopolis
country: Brazil
facility: Local Institution
state: Santa Catarina
city: Itajai
country: Brazil
facility: Local Institution
state: Santa Catarina
city: Barretos
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Campinas
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Jau
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Ribeirao Preto
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Distrito Federal
country: Brazil
facility: Local Institution
city: Rio de Janeiro
country: Brazil
facility: Local Institution
city: Rio de Janeiro
country: Brazil
facility: Local Institution
city: Salvador
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Burnaby
country: Canada
facility: Local Institution
state: British Columbia
city: Kelowna
country: Canada
facility: Local Institution
state: British Columbia
city: Richmond
country: Canada
facility: Local Institution
state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Moncton
country: Canada
facility: Local Institution
state: New Brunswick
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Oshawa
country: Canada
facility: Local Institution
state: Ontario
city: Sudbury
country: Canada
facility: Local Institution
state: Ontario
city: Thunder Bay
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Chicoutimi
country: Canada
facility: Local Institution
state: Quebec
city: Greenfield Park
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Rimouski
country: Canada
facility: Centre De Sante Et De Services Sociaux Rimouski Neigette
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: