Lung CancerPhase 3NCT03417037
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
A Phase 3 study testing BMS-986205, Nivolumab and Chemotherapy in people with Lung Cancer and Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 83 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-Small Cell Lung Cancer
- What is being tested?
- BMS-986205, Nivolumab and Chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 83 sitesin 17 countries
- Study dates
- 24 May 2018to 20 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
83 sites in 17 countries.
83 sites in 17 countries
United States19 sites
Local Institution
Boston, Massachusetts, 02114
Local Institution
Bridgeton, Missouri, 63044
Local Institution
Cleveland, Ohio, 44106
Local Institution
Decatur, Georgia, 30033
Local Institution
Fort Myers, Florida, 33916
Local Institution
Fort Worth, Texas, 76104
Local Institution
Gettysburg, Pennsylvania, 17325
Local Institution
Greenville, South Carolina, 29607
Local Institution
Jacksonville, Florida, 32256
Local Institution
Lebanon, Tennessee, 37087
Local Institution
Lincoln, Nebraska, 68510
Local Institution
Louisville, Kentucky, 40202
Local Institution
Lubbock, Texas, 79430-0002
Local Institution
Marietta, Georgia, 30060
Local Institution
San Diego, California, 92123
Local Institution
St. Petersburg, Florida, 33705
Local Institution
Tallahassee, Florida, 32308
Local Institution
West Palm Beach, Florida, 33401
Local Institution
Wichita, Kansas, 67214
Germany10 sites
Local Institution
Berlin, 14165
Local Institution
Gauting, 82131
Local Institution
Gera, 07548
Local Institution
Göttingen, 37075
Local Institution
Großhansdorf, 22927
Local Institution
Hamburg, 21075
Local Institution
Heidelberg, 69126
Local Institution
Oldenburg, 26121
Local Institution
Paderborn, 33098
Local Institution
Wiesbaden, 65199
Brazil8 sites
Local Institution
Barretos, São Paulo, 14780-070
Local Institution
Centro-porto Alegre, Rio Grande do Sul, 90050-170
Local Institution
Ijuí, Rio Grande do Sul, 98700-000
Local Institution
Ipatinga, Minas Gerais, 35160-158
Local Institution
Jd. Petropolis-Londrina, Paraná, 86015-520
Local Institution
Morumbi, São Paulo, 05652-900
Local Institution
Porto Alegre, Rio Grande do Sul, 90610-000
Local Institution
Rio de Janeiro, 22793-080
France8 sites
Local Institution
Besançon, 25030
Local Institution
La Tronche, 38700
Local Institution
Paris, 75248
Local Institution
Pessac, 33604
Local Institution
Pringy, 74374
Local Institution
Rennes, 35033
Local Institution
Saint-Herblain, 44805
Local Institution
Toulon, 83000
Italy6 sites
Local Institution
Modena, 41100
Local Institution
Monza (MB), 20900
Local Institution
Naples, 80131
Local Institution
Perugia, 06132
Local Institution
Ravenna, 48121
Local Institution
Reggio Emilia, 42100
Spain6 sites
Local Institution
A Coruña, Galicia, 15006
Local Institution
Barcelona, 08035
Local Institution
Madrid, 28041
Local Institution
Majadahonda - Madrid, 28222
Local Institution
Málaga, 29010
Local Institution
Valencia, 46026
Australia5 sites
Local Institution
Brisbane, Queensland, 4102
Local Institution
Darlinghurst, New South Wales, 2010
Local Institution
Melbourne, Victoria, 3004
Local Institution
Murdoch, Western Australia, 6150
Local Institution
North Tamworth, 2340
Japan4 sites
Local Institution
Fukushima, Fukushima, 9601295
Local Institution
Kitaadachi-gun, Saitama, 362-0806
Local Institution
Morioka, Iwate, 0208505
Local Institution
Osaka-sayama-shi, Osaka, 5898511
Turkey (Türkiye)4 sites
Local Institution
?stanbul, 34890
Local Institution
Adana, 01250
Local Institution
Antalya, 07070
Local Institution
Istanbul, 34098
Greece3 sites
Local Institution
Athens, 11527
Local Institution
Athens, 18547
Local Institution
Thessaloniki, 54 622
South Korea2 sites
Local Institution
Seoul, 03080
Local Institution
Seoul, 135-710
About this study
Official title: 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.
- Conditions
- Lung Cancer, Non-Small Cell Lung Cancer
- Being tested
- BMS-986205, Nivolumab, Chemotherapy
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986205Drug
Administered orally daily, 100 mg
NivolumabBiological
Also called Opdivo, BMS-936558
Specified dose on specified days
ChemotherapyDrug
Platinum-based doublet chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | BMS-986205 and Nivolumab administered in combination Receives: Drug: BMS-986205; Biological: Nivolumab |
| Arm B | Experimental | BMS-986205 and Nivolumab administered in combination with chemotherapy Receives: Drug: BMS-986205; Biological: Nivolumab; Drug: Chemotherapy |
| Arm C | Active comparator | Chemotherapy administered alone Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Approximately 5 years
Number of treatment-related adverse events (AE)
Measured: Approximately 5 years
Number of treatment-related serious adverse events
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start24 May 2018 (estimated)
- Primary completion25 Apr 2021 (estimated)
- Study completion20 Aug 2025 (estimated)
Why it stopped: Business objectives have changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417037
- Sponsor's protocol ID
- CA017-062
- Other IDs
- 2017-003058-18, 2017
- Status last verified
- Apr 2018
- First submitted
- 25 Jan 2018
- Last updated
- 30 Apr 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03417037
- Acronym / sponsor ID
- CA017-062
- Conditions
- Lung Cancer, Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 24 May 2018 (estimated)
- Primary completion
- 25 Apr 2021 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: BMS-986205, Biological: NivolumabBMS-986205 and Nivolumab administered in combination |
| Arm B | Experimental | Drug: BMS-986205, Biological: Nivolumab, Drug: ChemotherapyBMS-986205 and Nivolumab administered in combination with chemotherapy |
| Arm C | Active comparator | Drug: ChemotherapyChemotherapy administered alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986205Administered orally daily, 100 mg | Drug | Arm A, Arm B |
| NivolumabAlso: Opdivo, BMS-936558Specified dose on specified days | Biological | Arm A, Arm B |
| ChemotherapyPlatinum-based doublet chemotherapy | Drug | Arm B, Arm C |
Primary outcome
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
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
3 secondary outcomes
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
Number of treatment-related adverse events (AE)
Time frame: Approximately 5 years
Number of treatment-related serious adverse events
Time frame: Approximately 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
83 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BMS-986205, Nivolumab and Chemotherapy in people with Lung Cancer and Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 83 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States, Germany, Brazil, France, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.