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

Withdrawn before enrolling · Phase 3

Conditions studied: Lung Cancer, Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT03417037

Run by

Bristol-Myers Squibb

People needed

0

Starts

2018-05-24

Expected to finish

2025-08-20

Last updated by the study team

2018-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution — Fort Myers, Florida, United States
• Local Institution — Jacksonville, Florida, United States
• Local Institution — St. Petersburg, Florida, United States
• Local Institution — Tallahassee, Florida, United States
• Local Institution — West Palm Beach, Florida, United States
• Local Institution — Decatur, Georgia, United States
• Local Institution — Marietta, Georgia, United States
• Local Institution — Wichita, Kansas, United States
• Local Institution — Louisville, Kentucky, United States
• Local Institution — Boston, Massachusetts, United States
• Local Institution — Bridgeton, Missouri, United States
• Local Institution — Lincoln, Nebraska, United States
• Local Institution — Cleveland, Ohio, United States
• Local Institution — Gettysburg, Pennsylvania, United States
• Local Institution — Greenville, South Carolina, United States
• Local Institution — Lebanon, Tennessee, United States
• Local Institution — Fort Worth, Texas, United States
• Local Institution — Lubbock, Texas, United States
• Local Institution — Darlinghurst, New South Wales, Australia
• Local Institution — Brisbane, Queensland, Australia
• Local Institution — Melbourne, Victoria, Australia
• Local Institution — Murdoch, Western Australia, Australia
• Local Institution — North Tamworth, Australia
• Local Institution — Vienna, Austria
• Local Institution — San Diego, California, United States

Full record on ClinicalTrials.gov

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