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

NCT03417037 | Withdrawn Phase 3 FDA Drug

• 2 other identifiers: CA017-0622017-003058-18
• Study Type: interventional
• Target: N/A
• Locations: 16 countries
• Sites: 81

Brief Summary

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.

Conditions

Lung Cancer; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR) measured by number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group

  24 months

• Progression free survival (PFS) measured by the time between the date of randomization and the first date of documented progression, as determined by the Blinded Independent Central Review, or death, due to any cause, whichever occurs first

  34 months

Secondary Outcomes (3)

• Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause

  Approximately 5 years

• Number of treatment-related adverse events (AE)

  Approximately 5 years

• Number of treatment-related serious adverse events

  Approximately 5 years

Study Arms (3)

Arm A

EXPERIMENTAL

BMS-986205 and Nivolumab administered in combination

Drug: BMS-986205; Biological: Nivolumab

Arm B

EXPERIMENTAL

BMS-986205 and Nivolumab administered in combination with chemotherapy

Drug: BMS-986205; Biological: Nivolumab; Drug: Chemotherapy

Arm C

ACTIVE COMPARATOR

Chemotherapy administered alone

Drug: Chemotherapy

Interventions

BMS-986205 DRUG

Administered orally daily, 100 mg

Arm A; Arm B

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Arm A; Arm B

Chemotherapy DRUG

Platinum-based doublet chemotherapy

Arm B; Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (83)

Local Institution

San Diego, California, 92123, United States

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Fort Myers, Florida, 33916, United States

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Jacksonville, Florida, 32256, United States

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St. Petersburg, Florida, 33705, United States

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Tallahassee, Florida, 32308, United States

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West Palm Beach, Florida, 33401, United States

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Decatur, Georgia, 30033, United States

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Marietta, Georgia, 30060, United States

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Wichita, Kansas, 67214, United States

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Louisville, Kentucky, 40202, United States

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Boston, Massachusetts, 02114, United States

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Bridgeton, Missouri, 63044, United States

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Lincoln, Nebraska, 68510, United States

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Cleveland, Ohio, 44106, United States

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Gettysburg, Pennsylvania, 17325, United States

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Greenville, South Carolina, 29607, United States

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Lebanon, Tennessee, 37087, United States

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Fort Worth, Texas, 76104, United States

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Lubbock, Texas, 79430-0002, United States

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Darlinghurst, New South Wales, 2010, Australia

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Brisbane, Queensland, 4102, Australia

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Melbourne, Victoria, 3004, Australia

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Murdoch, Western Australia, 6150, Australia

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North Tamworth, 2340, Australia

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Vienna, 1090, Austria

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Wels, 4600, Austria

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Ipatinga, Minas Gerais, 35160-158, Brazil

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Jd. Petropolis-Londrina, Paraná, 86015-520, Brazil

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Centro-porto Alegre, Rio Grande do Sul, 90050-170, Brazil

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Ijuí, Rio Grande do Sul, 98700-000, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Barretos, São Paulo, 14780-070, Brazil

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Morumbi, São Paulo, 05652-900, Brazil

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Rio de Janeiro, 22793-080, Brazil

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Québec, Quebec, G1R 2J6, Canada

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Prague, 128 08, Czechia

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Besançon, 25030, France

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La Tronche, 38700, France

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Paris, 75248, France

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Pessac, 33604, France

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Pringy, 74374, France

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Rennes, 35033, France

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Saint-Herblain, 44805, France

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Toulon, 83000, France

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Berlin, 14165, Germany

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Gauting, 82131, Germany

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Gera, 07548, Germany

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Göttingen, 37075, Germany

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Großhansdorf, 22927, Germany

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Hamburg, 21075, Germany

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Heidelberg, 69126, Germany

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Oldenburg, 26121, Germany

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Paderborn, 33098, Germany

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Wiesbaden, 65199, Germany

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Athens, 11527, Greece

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Athens, 18547, Greece

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Thessaloniki, 54 622, Greece

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Modena, 41100, Italy

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Monza (MB), 20900, Italy

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Napoli, 80131, Italy

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Perugia, 06132, Italy

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Ravenna, 48121, Italy

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Reggio Emilia, 42100, Italy

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Fukushima, Fukushima, 9601295, Japan

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Morioka, Iwate, 0208505, Japan

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Osaka-sayama-shi, Osaka, 5898511, Japan

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Kitaadachi-gun, Saitama, 362-0806, Japan

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Mérida, Yucatán, 97070, Mexico

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Seoul, 03080, South Korea

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Seoul, 135-710, South Korea

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A Coruña, Galicia, 15006, Spain

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Barcelona, 08035, Spain

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Madrid, 28041, Spain

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Majadahonda - Madrid, 28222, Spain

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Málaga, 29010, Spain

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Valencia, 46026, Spain

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Basel, 4031, Switzerland

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Taipei, 11217, Taiwan

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Taipei, Taiwan

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?stanbul, 34890, Turkey (Türkiye)

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Adana, 01250, Turkey (Türkiye)

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Antalya, 07070, Turkey (Türkiye)

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Istanbul, 34098, Turkey (Türkiye)

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

linrodostat; Nivolumab; Drug Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: January 31, 2018
• Study Start: May 24, 2018
• Primary Completion: April 25, 2021
• Study Completion: August 20, 2025
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

DE (10); JP (4); ME (1); TW (2); BR (8); ES (6); TU (4); KR (2); GR (3); CZ (1); IT (6); US (19); AU (5); CA (1); CH (1); FR (8)