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
NCT ID: NCT03417037
Last Updated: 2018-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2018-05-24
2025-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
BMS-986205 and Nivolumab administered in combination
BMS-986205
Administered orally daily, 100 mg
Nivolumab
Specified dose on specified days
Arm B
BMS-986205 and Nivolumab administered in combination with chemotherapy
BMS-986205
Administered orally daily, 100 mg
Nivolumab
Specified dose on specified days
Chemotherapy
Platinum-based doublet chemotherapy
Arm C
Chemotherapy administered alone
Chemotherapy
Platinum-based doublet chemotherapy
Interventions
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BMS-986205
Administered orally daily, 100 mg
Nivolumab
Specified dose on specified days
Chemotherapy
Platinum-based doublet chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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 \[Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment\]
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
San Diego, California, United States
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
Wels, , Austria
Local Institution
Ipatinga, Minas Gerais, Brazil
Local Institution
Jd. Petropolis-Londrina, Paraná, Brazil
Local Institution
Centro-porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Ijuí, Rio Grande do Sul, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Barretos, São Paulo, Brazil
Local Institution
Morumbi, São Paulo, Brazil
Local Institution
Rio de Janeiro, , Brazil
Local Institution
Québec, Quebec, Canada
Local Institution
Prague, , Czechia
Local Institution
Besançon, , France
Local Institution
La Tronche, , France
Local Institution
Paris, , France
Local Institution
Pessac, , France
Local Institution
Pringy, , France
Local Institution
Rennes, , France
Local Institution
Saint-Herblain, , France
Local Institution
Toulon, , France
Local Institution
Berlin, , Germany
Local Institution
Gauting, , Germany
Local Institution
Gera, , Germany
Local Institution
Göttingen, , Germany
Local Institution
Großhansdorf, , Germany
Local Institution
Hamburg, , Germany
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Heidelberg, , Germany
Local Institution
Oldenburg, , Germany
Local Institution
Paderborn, , Germany
Local Institution
Wiesbaden, , Germany
Local Institution
Athens, , Greece
Local Institution
Athens, , Greece
Local Institution
Thessaloniki, , Greece
Local Institution
Modena, , Italy
Local Institution
Monza (MB), , Italy
Local Institution
Napoli, , Italy
Local Institution
Perugia, , Italy
Local Institution
Ravenna, , Italy
Local Institution
Reggio Emilia, , Italy
Local Institution
Fukushima, Fukushima, Japan
Local Institution
Morioka, Iwate, Japan
Local Institution
Osaka-sayama-shi, Osaka, Japan
Local Institution
Kitaadachi-gun, Saitama, Japan
Local Institution
Mérida, Yucatán, Mexico
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
A Coruña, Galicia, Spain
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Majadahonda - Madrid, , Spain
Local Institution
Málaga, , Spain
Local Institution
Valencia, , Spain
Local Institution
Basel, , Switzerland
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
?stanbul, , Turkey (Türkiye)
Local Institution
Adana, , Turkey (Türkiye)
Local Institution
Antalya, , Turkey (Türkiye)
Local Institution
Istanbul, , Turkey (Türkiye)
Countries
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Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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2017-003058-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA017-062
Identifier Type: -
Identifier Source: org_study_id