Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT02409368
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02409368
Study Brief:
Protocol Section:
NCT02409368