This trial is active, not recruiting.

Condition squamous cell non-small cell lung cancer
Treatments nivolumab, docetaxel
Phase phase 3
Target PD-1
Sponsor Bristol-Myers Squibb
Start date September 2012
End date November 2014
Trial size 264 participants
Trial identifier NCT01642004, 2011-004792-36, CA209-017


The purpose of the study is to compare the change in tumor size, and overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
nivolumab BMS-936558
Docetaxel 75 mg/m2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
docetaxel Taxotere®

Primary Outcomes

Overall Survival (OS) of BMS-936558 (Nivolumab) versus Docetaxel in subjects with squamous cell NSCLC after failure of prior-platinum doublet-based chemotherapy
time frame: 38 months

Secondary Outcomes

ORR of BMS-936558 (Nivolumab) versus Docetaxel
time frame: 38 months
PFS of BMS-936558 (Nivolumab) versus Docetaxel
time frame: 38 months
Potential association between PD-L1 expression and efficacy measures (ORR, OS PFS) will be assessed
time frame: 38 Months
QoL measured by disease-related symptom improvement rate in BMS-936558 (Nivolumab) and Docetaxel groups
time frame: 38 Months

Eligibility Criteria

Male or female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Men and women ≥18 years of age - Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease) - Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease - Measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria - Eastern Cooperative Oncology Group (ECOG) performance status ≤1 - An formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient Exclusion Criteria: - Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) - Subjects with carcinomatous meningitis - Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll - Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization - Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) - Prior treatment on the first line study CA184104 first line NSCLC study - Prior treatment with Docetaxel - Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity - Treatment with any investigational agent within 14 days of first administration of study treatment

Additional Information

Official title An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.