An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer



Status:Withdrawn
Conditions:Lung Cancer, Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/2/2018
Start Date:May 24, 2018
End Date:August 20, 2025

Use our guide to learn which trials are right for you!

A Phase 3 Open Label, Randomized Study of BMS-986205 Combined With Nivolumab With or Without Chemotherapy Versus Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer

This is a study of experimental medication BMS-986205 given with Nivolumab with or without
chemotherapy compared to chemotherapy in participants with previously untreated stage IV or
recurrent non-small cell lung cancer.


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Histologically confirmed stage IV NSCLC per the 8th IASLC of squamous or nonsquamous
histology

- Locally advanced disease with recurrence after chemoradiation therapy (stage IIIB
disease, specifically refers to patients with no curative treatment options)

- No prior systemic anti-cancer therapy (including EGFR and ALK/ROS1 inhibitors) given
as primary therapy for advanced or metastatic disease

- Participants must have biomarker test results available for randomization

- ECOG Performance Status of ≤ 1

- Measurable disease by CT or MRI per RECIST 1.1 criteria

Exclusion Criteria:

- Participants with known sensitizing EGFR mutations or known ALK/ROS1 rearrangements

- Participants with interstitial lung disease that is symptomatic or may interfere with
the detection or management of suspected drug-related pulmonary toxicity

- Participants with an active, known or suspected autoimmune disease [Participants with
type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin
disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment,
or conditions not expected to recur in the absence of an external trigger are
permitted to enroll]

- Participants with untreated CNS metastases are excluded [Participants are eligible if
CNS metastases are adequately treated and participants are neurologically returned to
baseline (except for residual signs or symptoms related to the CNS treatment) for at
least 2 weeks prior to first treatment]

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
20
sites
300 North Washington Street
Gettysburg, Pennsylvania 17325
?
mi
from
Gettysburg, PA
Click here to add this to my saved trials
Boston, Massachusetts 02111
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bridgeton, Missouri 63044
?
mi
from
Bridgeton, MO
Click here to add this to my saved trials
Cleveland, Ohio 44195
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Darlinghurst, New South Wales
?
mi
from
Darlinghurst,
Click here to add this to my saved trials
2675 North Decatur Road
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Fort Myers, Florida 33908
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Fort Worth, Texas 76164
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Lebanon, Tennessee 37087
?
mi
from
Lebanon, TN
Click here to add this to my saved trials
Lincoln, Nebraska 68506
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lubbock, Texas
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Saint Petersburg, Florida 33701
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Tallahassee, Florida 32308
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
West Palm Beach, Florida 33401
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Wichita, Kansas 67214
?
mi
from
Wichita, KS
Click here to add this to my saved trials