An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC (Checkmate 171)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02409368

CA209-171

2014-001285-10 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.

Enrollment

812 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

ECOG Status: PS 0-1 & PS 2
Subjects with histologically or cytologically-documented SqNSCLC
Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen
Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria
Subjects with treated or asymptomatic CNS metastases
Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab
Males and Females, ages 18 or older

Exclusion Criteria:

Subjects with untreated, symptomatic CNS metastases
Subjects with carcinomatous meningitis
Subjects with active, known or suspected autoimmune disease.
Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.