Squamous Non-Small Cell Lung CancerCheckMate 169NCT02475382
Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen
A study testing Nivolumab in people with Squamous Non-Small Cell Lung Cancer and Non-squamous Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 50 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Non-Small Cell Lung Cancer, Non-squamous Non-Small Cell Lung Cancer
- What is being tested?
- Nivolumab
- How many people
- Not given
- Where
- 50 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
50 sites in 2 countries.
50 sites in 2 countries
Brazil35 sites
Local Institution
Barretos, São Paulo, 14784
Local Institution
Belo Horizonte, Minas Gerais, 30430
Local Institution
Brasília, Federal District, 70200
Local Institution
Campinas, São Paulo, 13092
Local Institution
Cascavel, Paraná, 85806
Local Institution
Curitiba, Paraná, 80530
Local Institution
Curitiba, Paraná
Local Institution
Distrito Federal, Federal District, 72025
Local Institution
Florianópolis, Santa Catarina, 88034
Local Institution
Fortaleza, Ceará, 60130
Local Institution
Fortaleza, Ceará, 60336
Local Institution
Ijuí, Rio Grande do Sul
Local Institution
Itajaí, Santa Catarina, 88301
Local Institution
Jaú, São Paulo, 17210
Local Institution
Natal, Rio Grande do Norte, 59062
Local Institution
Passo Fundo, Rio Grande do Sul, 99010
Local Institution
Porto Alegre, Rio Grande do Sul, 90020
Local Institution
Porto Alegre, Rio Grande do Sul, 90035
Local Institution
Porto Alegre, Rio Grande do Sul, 90470
Local Institution
Porto Alegre, Rio Grande do Sul
Local Institution
Recife, Pernambuco, 50070
Local Institution
Recife, Pernambuco, 52010
Local Institution
Ribeirão Preto, São Paulo, 14025
Local Institution
Rio de Janeiro, 22793
Local Institution
Rio de Janeiro
Local Institution
Salvador, Estado de Bahia, 41950
Local Institution
Salvador, 40170
Local Institution
Santo André, São Paulo, 09060
Local Institution
São Paulo, 01308
Local Institution
São Paulo, 01321
Local Institution
São Paulo, 01406
Local Institution
São Paulo, 01525
Local Institution
São Paulo, 03102
Local Institution
São Paulo, 04538
Local Institution
São Paulo, 05651
Canada15 sites
Local Institution
Burnaby, British Columbia, V5G 2X6
Local Institution
Chicoutimi, Quebec, G7H 2A4
Local Institution
Edmonton, Alberta, T6G 1Z2
Local Institution
Greater Sudbury, Ontario, P3E 5J1
Local Institution
Greenfield Park, Quebec, J4V 2H1
Local Institution
Hamilton, Ontario
Local Institution
Kelowna, British Columbia, V1Y 5L3
Local Institution
Moncton, New Brunswick, E1C 2Z3
Local Institution
Montreal, Quebec, H3A 1A1
Local Institution
Oshawa, Ontario, L1G 2B9
Local Institution
Richmond, British Columbia, V6X 1A2
Centre De Sante Et De Services Sociaux Rimouski Neigette
Rimouski, Quebec, G5L 5T1
Local Institution
Thunder Bay, Ontario, P7B 6V4
Local Institution
Toronto, Ontario, M4N 3M5
Local Institution
Winnipeg, Manitoba, R3E 0V9
About this study
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
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.
- Being tested
- Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Specified dose on specified days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475382
- Sponsor's protocol ID
- CA209-169
- Acronym
- CheckMate 169
- Status last verified
- Nov 2020
- First submitted
- 16 Jun 2015
- Last updated
- 27 Nov 2020
- Results posted
- No
Publications
Parodi D, Dighero E, Biddau G, D'Amico F, Bauckneht M, Marini C, Garbarino S, Campi C, Piana M, Sambuceti G. Localized FDG loss in lung cancer lesions. EJNMMI Res. 2024 Nov 1;14(1):102. doi: 10.1186/s13550-024-01161-y.
PubMed 39485534
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02475382
- Acronym / sponsor ID
- CheckMate 169 / CA209-169
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabSpecified dose on specified days | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Derived from this study: PubMed 39485534Parodi D, Dighero E, Biddau G, D'Amico F, Bauckneht M, Marini C, Garbarino S, Campi C, Piana M, Sambuceti G. Localized FDG loss in lung cancer lesions. EJNMMI Res. 2024 Nov 1;14(1):102. doi: 10.1186/s13550-024-01161-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
50 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nivolumab in people with Squamous Non-Small Cell Lung Cancer and Non-squamous Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 50 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Brazil, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02475382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.