A Clinical Trial to be conducted in many hospitals and in different countries with the medicinal substance Nivolumab as the only therapy in patients with Non-Small Cell Lung Cancer (NSCLC) who have received earlier cancer treatments.

Conditions: Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC)
MedDRA version: 18.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-001285-10-ES

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1800

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; maximum of 300 subjects; clinical risk/benefit ratio will be monitored by the Scientific Steering Committee 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. Enrollees must not be eligible for another clinical study with nivolumab. A fresh biopsy is not required to take part in the study.
c) Subjects must have experienced disease progression or recurrence during or after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
i) Additional systemic therapies are defined as agents that are locally accepted and established for use as monotherapy or in combination for the treatment of stage IIIb/stage IV SqNSCLC.
ii) Experimental therapies when given as a separate regimen are considered as separate lines of therapy.
iii) Maintenance therapy following platinum doublet-based chemotherapy is not considered a separate line of therapy.
iv) Prior platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease is considered first-line therapy only if recurrent (local or metastatic) or progressive disease developed within 6 months of completing therapy. Subjects with recurrent disease > 6 months must also have progressed during or after at least 2 subsequent regimens (a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy OR at least 2 additional systemic therapies) given to treat the recurrence
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 < or = 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 < or = 10 mg daily prednisone (or equivalent)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Key exclusion criteria:
a) Subjects with untreated, symptomatic CNS metastases are excluded
b) Subjects with carcinomatous meningitis are excluded.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 2 systemic therapies.;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<br>-To estimate overall survival (OS) in all treated subjects<br>-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 or higher), treatment-related, select adverse events;Timepoint(s) of evaluation of this end point: 5 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints include: <br>-Incidence of high grade (Grade 3-4) select adverse events<br>-Median time to onset and median time to resolution (Grades 3-4) of select adverse events<br>-OS is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug. <br>-ORR is defined as the number and percentage of subjects with a best overall response (BOR) of confirmed CR or PR. ORR as assessed by the investigator will be reported.;Timepoint(s) of evaluation of this end point: 5 years

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