West Cancer Center

LUNG: Metastatic; NSCLC; anti-PD-1; >/= 2nd line; "CheckMate 153"

A phase IIIb/IV safety trial of nivolumab (BMS-936558) in subjects with advanced or metastatic non-small cell lung cancer who have progressed during or after receiving at least one prior systemic regimen

Title

Bristol-Myers Squibb CA209-153

Study Title

Site Link

NCT02066636

Malignancy

lung cancer (c), adenocarcinoma, squamous cell carcinoma

Stage

Stage 4

Disease Setting

Metastatic/palliative

Line Of Therapy

>�2nd line

Investigational Agent

Nivolumab

Drug Class

PD-1 inhibitor (antibody)

Jason Chandler, MD

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02066636

Key Eligibility Criteria Details

IIIB or IV non-small cell lung cancer
Progression during or after at least one�prior systemic therapies
� �Progression within 6 months of adjuvant tx counts as 1st line
EGFR or ALK mutations are eligible if progressed on on anti-EGFR or anti-ALK
ECOG PS 0-2
No active CNS disease
No history of interstitial lung disease
No history of autoimmune disease
No prior PD-1 inhibitors
Willingness to undergo on-treatment biopsies

Objective

Primary- High grade trAEs; Secondary- other high-grade AEs, use of steroids or immune modulators for AEs, time to onset and resolution of AEs

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma or squamous cell carcinoma

Dosing Frequency

Nivolumab 3mg/kg IV q2 weeks until progression (Cohort 1) or for 1 year (Cohort 2)

Control Agents

Study Protocol

Randomized