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

April 26, 2018 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • North Tamworth, Australia, 2340
        • Local Institution
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Local Institution
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Local Institution
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Local Institution
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution
  • Austria
      • Vienna, Austria, 1090
        • Local Institution
      • Wels, Austria, 4600
        • Local Institution
  • Brazil
      • Rio de Janeiro, Brazil, 22793-080
        • Local Institution
    • Minas Gerais
      • Ipatinga, Minas Gerais, Brazil, 35160-158
        • Local Institution
    • Parana
      • Jd. Petropolis-Londrina, Parana, Brazil, 86015-520
        • Local Institution
    • RIO Grande DO SUL
      • Centro-porto Alegre, RIO Grande DO SUL, Brazil, 90050-170
        • Local Institution
      • Ijui, RIO Grande DO SUL, Brazil, 98700-000
        • Local Institution
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
        • Local Institution
    • SAO Paulo
      • Barretos, SAO Paulo, Brazil, 14780-070
        • Local Institution
      • Morumbi, SAO Paulo, Brazil, 05652-900
        • Local Institution
  • Canada
      • Quebec, Canada, G1R 2J6
        • Local Institution
  • Czechia
      • Praha 2, Czechia, 128 08
        • Local Institution
  • France
      • Besancon, France, 25030
        • Local Institution
      • La Tronche, France, 38700
        • Local Institution
      • Paris Cedex 5, France, 75248
        • Local Institution
      • Pessac cedex, France, 33604
        • Local Institution
      • Pringy Cedex, France, 74374
        • Local Institution
      • Rennes Cedex 9, France, 35033
        • Local Institution
      • Saint Herblain, France, 44805
        • Local Institution
      • Toulon, France, 83000
        • Local Institution
  • Germany
      • Berlin, Germany, 14165
        • Local Institution
      • Gauting, Germany, 82131
        • Local Institution
      • Gera, Germany, 07548
        • Local Institution
      • Gottingen, Germany, 37075
        • Local Institution
      • Grosshansdorf, Germany, 22927
        • Local Institution
      • Hamburg, Germany, 21075
        • Local Institution
      • Heidelberg, Germany, 69126
        • Local Institution
      • Oldenburg, Germany, 26121
        • Local Institution
      • Paderborn, Germany, 33098
        • Local Institution
      • Wiesbaden, Germany, 65199
        • Local Institution
  • Greece
      • Athens, Greece, 11527
        • Local Institution
      • Athens, Greece, 18547
        • Local Institution
      • Thessaloniki, Greece, 54 622
        • Local Institution
  • Italy
      • Modena, Italy, 41100
        • Local Institution
      • Monza (MB), Italy, 20900
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Perugia, Italy, 06132
        • Local Institution
      • Ravenna, Italy, 48121
        • Local Institution
      • Reggio Emilia, Italy, 42100
        • Local Institution
  • Japan
    • Fukushima
      • Fukushima-shi, Fukushima, Japan, 9601295
        • Local Institution
    • Iwate
      • Morioka-shi, Iwate, Japan, 0208505
        • Local Institution
    • Osaka
      • Osaka-sayama-shi, Osaka, Japan, 5898511
        • Local Institution
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Local Institution
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Local Institution
      • Seoul, Korea, Republic of, 03080
        • Local Institution
  • Mexico
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Local Institution
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution
      • Madrid, Spain, 28041
        • Local Institution
      • Majadahonda - Madrid, Spain, 28222
        • Local Institution
      • Malaga, Spain, 29010
        • Local Institution
      • Valencia, Spain, 46026
        • Local Institution
    • Galicia
      • A Coruna, Galicia, Spain, 15006
        • Local Institution
  • Switzerland
      • Basel, Switzerland, 4031
        • Local Institution
  • Taiwan
      • Taipei, Taiwan
        • Local Institution
      • Taipei, Taiwan, 11217
        • Local Institution
  • Turkey
      • ?stanbul, Turkey, 34890
        • Local Institution
      • Adana, Turkey, 01250
        • Local Institution
      • Antalya, Turkey, 07070
        • Local Institution
      • Istanbul, Turkey, 34098
        • Local Institution
  • United States
    • California
      • San Diego, California, United States, 92123
        • Local Institution
    • Florida
      • Fort Myers, Florida, United States, 33916
        • Local Institution
      • Jacksonville, Florida, United States, 32256
        • Local Institution
      • Saint Petersburg, Florida, United States, 33705
        • Local Institution
      • Tallahassee, Florida, United States, 32308
        • Local Institution
      • West Palm Beach, Florida, United States, 33401
        • Local Institution
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Local Institution
      • Marietta, Georgia, United States, 30060
        • Local Institution
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Local Institution
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Local Institution
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Local Institution
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Local Institution
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Local Institution
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Local Institution
    • Tennessee
      • Lebanon, Tennessee, United States, 37087
        • Local Institution
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Local Institution
      • Lubbock, Texas, United States, 79430-0002
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
BMS-986205 and Nivolumab administered in combination
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986205
Administered orally daily, 100 mg
Experimental: Arm B
BMS-986205 and Nivolumab administered in combination with chemotherapy
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: BMS-986205
Administered orally daily, 100 mg
Drug: Chemotherapy
Platinum-based doublet chemotherapy
Active Comparator: Arm C
Chemotherapy administered alone
Drug: Chemotherapy
Platinum-based doublet chemotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: 24 months
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
Time Frame: 34 months
34 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause
Time Frame: Approximately 5 years
Approximately 5 years
Number of treatment-related adverse events (AE)
Time Frame: Approximately 5 years
Approximately 5 years
Number of treatment-related serious adverse events
Time Frame: Approximately 5 years
Approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA017-062
  • 2017-003058-18 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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