Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria a) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): i) PS 0 to 1 (Subgroup1) ii) PS 2 (Subgroup 2; minimum of 95 enrolled (81 treated) subjects. The Scientific Steering Committee will provide guidance and scientific expertise on the risk/benefit ratio following a Safety Management Plan). b) Subjects with histologically or cytologically-documented SqNSCLC who presented with stage IIIb/stage IV disease or who developed recurrent or progressive disease following prior definitive therapy for localized or local advanced disease. A fresh biopsy is not required to take part in the study. c) Subjects must have experienced disease recurrence or progression during or after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease. i) Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy ii) Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible. iii) Subjects with recurrent disease > 6 months after platinumcontaining adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence, are eligible. d) Subjects with CNS metastases: i) Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first dose. In addition, subjects must be either off corticosteroids or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent) OR ii) Subjects are eligible if they have previously untreated CNS metastases that are neurologically asymptomatic. In addition, subjects must be either off corticosteroids or on a stable or decreasing dose of =65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: Key exclusion criteria: a) Subjects with untreated, symptomatic CNS metastases are excluded b) Subjects with carcinomatous meningitis are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the incidence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in subjects with advanced or metastatic SqNSCLC who progressed during or after at least 1 systemic therapy.;Secondary Objective: • To determine the incidence and to characterize the outcome of all high-grade (CTCAE v4.0 Grades 3-4), select adverse events in subjects with advanced or metastatic SqNSCLC who have progressed during or after at least 2 prior systemic therapies and are treated with nivolumab monotherapy • To estimate overall survival (OS) in all treated subjects • To estimate investigator-assessed objective response rate (ORR) ;Primary end point(s): The primary endpoint is the incidence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events ;Timepoint(s) of evaluation of this end point: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints include: • Incidence of high grade (Grade 3-4) select adverse events • Median time to onset and median time to resolution (Grades 3-4) of select adverse events • OS • ORR ;Timepoint(s) of evaluation of this end point: 5 years | — |
Countries
Austria, Denmark, Finland, Germany, Greece, Hungary, Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, United Kingdom
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed